A Phase 2 interventional study of GS-5734 and Placebo Comparator in Ebola, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 2 sites in 2 countries. Open to male participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-02-15.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment
Background:
Some people have Ebola virus in their body for months after they recover from Ebola virus disease. Some may have health problems from the virus while others are fine. These people may be able to pass the virus to others. There are currently no drugs for people who have survived Ebola virus disease but still have the virus in their body. A new drug, GS-5734, might help get rid of Ebola virus in semen.
Objective:
To test if GS-5734 helps get rid of Ebola virus in semen and is safe for humans.
Eligibility:
Men who participated in the Ebola survivor study (PREVAIL III) and have evidence of the Ebola virus in their semen
Design:
Participants will be screened with:
Questions
Physical exam
Eye exam
Blood tests
2 semen samples if they have not had it tested recently
Participants must live near the study site in Liberia for 6 months.
Participants will be put into 1 of 2 study groups. They will have an infusion of either GS-5734 or a placebo every day for 5 days. A plastic tube is put into an arm vein. The infusion lasts 1 hour.
Participants will be observed for 1 hour after. They will provide a semen sample on infusion day 4.
After the infusions, participants will have 5 visits in the first month, then 1 per month for 5 more months. These include giving a blood and semen sample.
Blood tests are performed before and after each infusion and the last visit (5 month visit) will also include an eye exam.
When the study is over, if the study drug works and is safe, participants who got the placebo can get the study drug.
With the unprecedented size of the recent 2014-2016 West African Ebola outbreak, the scientific community is learning a great deal about the psychological and physical consequences of Ebola, Ebola viral persistence in survivors, risk of Ebola disease relapse in survivors, and the potential for survivors to transmit the virus to others. Data from PREVAIL III has demonstrated that persistence of Ebola virus in the semen of male survivors is common. In addition to Ebola virus persistence, Ebola relapse causing clinical disease has been well documented.
There are no licensed therapies for the treatment of Ebola virus disease nor for the clearance of persistent Ebola virus in survivors. A safe, effective therapy that can reduce and/or eliminate persistent Ebola virus from semen would reduce the risk of transmission and enable male survivors to resume normal sexual relations without fear of harming loved ones. The mechanism underlying Post-Ebola Syndrome is as yet unknown, but improvement in Post-Ebola signs and symptoms resulting from GS-5734 treatment would be an added benefit.
This study is a double-blind, randomized, two-phase (treatment and longer-term follow-up), two- arm trial of GS-5734 versus placebo among male Ebola survivors with persistent Ebola virus RNA in their semen. Participants are randomized 1:1 to receive either 100 mg of GS-5734 or placebo once daily by intravenous catheter for 5 days. Informed by transaminase elevations in prior Phase I studies in normal healthy subjects, a risk-mitigation strategy includes a built-in dose de-escalation. Participants will be stratified by country and on the basis of one versus two positive semen samples for Ebola virus RNA using the Cepheid GeneXpert platform assessed within 42 days prior to study enrollment. The early Data Safety and Monitoring Board (DSMB) review in August 2016 concluded there was no need for a cohort dose reduction. The protocol expanded to Guinea in October 2017, where the outbreak ended later. Currently there is an outbreak in the Democratic Republic of the Congo where the study team may evaluate conducting this study following the completion of the outbreak.
Antiviral activity, as well as safety and tolerability, will be assessed during the treatment phase. Longer-term clearance of Ebola virus will be assessed during the 5-month follow-up phase. Primary analyses for the assessment of antiviral activity in the treatment phase will focus on the assay negativity rate (ANR; percentage of genital samples that are negative for Ebola) over the first 28 days of the study, as well as clinical and laboratory adverse events. A sample is considered negative by PCR if the test result is undetectable. Primary analysis for the follow-up phase will focus on the ANR collected monthly from months 2 to 6.
104 studies on the registry are indexed under Hemorrhagic Fever, Ebola; 13 are open to participants now.
This study's enrollment of 38 is below the median of 94 across 81 interventional studies indexed under Hemorrhagic Fever, Ebola.
Browse Hemorrhagic Fever, Ebola studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Individuals must meet all of the following criteria to be eligible for study participation:
EXCLUSION CRITERIA:
Individuals meeting any of the following criteria will be excluded from study participation:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Male Ebola survivors with persistent Ebola virus in their semen were given GS-5734 100mg intravenously daily for 5 days
Drug: GS-5734
Male Ebola survivors with persistent Ebola virus in their semen were given normal saline intravenously daily for 5 days
Other: Placebo Comparator
Daily GS-5734 delivered intravenously (IV) for 5 days
Placebo delivered intravenously (IV) for 5 days.
Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase
Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, \& 28. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.
Time frame: Treatment Phase (assessed at days 4, 8, 11, 16, 20, 24, & 28)
Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase
Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase on weeks 8, 12, 16, 20, \& 24. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.
Time frame: Follow-up phase (assessed on weeks 8, 12, 16, 20, & 24)
Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase
Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, \& 28. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.
Time frame: Treatment Phase (assessed on days 4, 8, 11, 16, 20, 24, & 28)
Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase
Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase - weeks 8, 12, 16, 20, \& 24. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.
Time frame: Follow-up phase (assessed on weeks 8, 12, 16, 20, & 24)
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at day 1
Time frame: Treatment phase - Day 1
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at day 2
Time frame: Treatment phase - Day 2
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at day 3
Time frame: Treatment phase - Day 3
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at day 4
Time frame: Treatment phase - Day 4
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at day 5
Time frame: Treatment phase - Day 5
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at day 8
Time frame: Treatment phase - Day 8
Mean Change From Baseline in ALT Value at Day 11
Mean change from baseline in alanine transaminase (ALT) value at day 11
Time frame: Treatment phase - Day 11
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at day 16
Time frame: Treatment phase - Day 16
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at at day 24
Time frame: Treatment phase - Day 24
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at at day 28
Time frame: Treatment phase - Day 28
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at week 8
Time frame: Follow-up phase - Week 8
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) Value at week 12
Time frame: Follow-up phase - Week 12
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at week 16
Time frame: Follow-up phase - Week 16
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at week 20
Time frame: Follow-up phase - Week 20
Mean Change From Baseline in ALT Value
Mean change from baseline in alanine transaminase (ALT) value at week 24
Time frame: Follow-up phase - Week 24
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 1
Time frame: Treatment phase - Day 1
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 2
Time frame: Treatment phase - Day 2
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 3
Time frame: Treatment phase - Day 3
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 4
Time frame: Treatment phase - Day 4
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 5
Time frame: Treatment phase - Day 5
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 8
Time frame: Treatment phase - Day 8
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 11
Time frame: Treatment phase - Day 11
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 16
Time frame: Treatment phase - Day 16
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 24
Time frame: Treatment phase - Day 24
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 28
Time frame: Treatment phase - Day 28
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 8
Time frame: Follow-up phase - Week 8
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 12
Time frame: Follow-up phase - Week 12
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 16
Time frame: Follow-up phase - Week 16
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 20
Time frame: Follow-up phase - Week 20
Mean Change From Baseline in aPTT Value
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 24
Time frame: Follow-up phase - Week 24
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) Value at day 1
Time frame: Treatment phase - Day 1
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) Value at day 2
Time frame: Treatment phase - Day 2
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at day 3
Time frame: Treatment phase - Day 3
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at day 4
Time frame: Treatment phase - Day 4
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at day 5
Time frame: Treatment phase - Day 5
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at day 8
Time frame: Treatment phase - Day 8
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at day 11
Time frame: Treatment phase - Day 11
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at day 16
Time frame: Treatment phase - Day 16
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at day 24
Time frame: Treatment phase - Day 24
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at day 28
Time frame: Treatment phase - Day 28
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at week 8
Time frame: Follow-up phase - Week 8
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 12
Time frame: Follow-up phase - Week 12
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 16
Time frame: Follow-up phase - Week 16
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 20
Time frame: Follow-up phase - Week 20
Mean Change From Baseline in AST Value
Mean change from baseline in aspartate transaminase (AST) value at week 24
Time frame: Follow-up phase - Week 24
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 1
Time frame: Treatment phase - Day 1
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 2
Time frame: Treatment phase - Day 2
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 3
Time frame: Treatment phase - Day 3
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 4
Time frame: Treatment phase - Day 4
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 5
Time frame: Treatment phase - Day 5
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 8
Time frame: Treatment phase - Day 8
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 11
Time frame: Treatment phase - Day 11
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 16
Time frame: Treatment phase - Day 16
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 24
Time frame: Treatment phase - Day 24
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at day 28
Time frame: Treatment phase - Day 28
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at week 8
Time frame: Follow-up phase - Week 8
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at week 12
Time frame: Follow-up phase - Week 12
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at week 16
Time frame: Follow-up phase - Week 16
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at week 20
Time frame: Follow-up phase - Week 20
Mean Change From Baseline in INR Value
Mean change from baseline in international normalized ratio (INR) value at week 24
Time frame: Follow-up phase - Week 24
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 1
Time frame: Treatment phase - Day 1
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 2
Time frame: Treatment phase - Day 2
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 3
Time frame: Treatment phase - Day 3
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 4
Time frame: Treatment phase - Day 4
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 5
Time frame: Treatment phase - Day 5
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 8
Time frame: Treatment phase - Day 8
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 11
Time frame: Treatment phase - Day 11
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 16
Time frame: Treatment phase - Day 16
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 24
Time frame: Treatment phase - Day 24
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at day 28
Time frame: Treatment phase - Day 28
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at week 8
Time frame: Follow-up phase - Week 8
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at week 12
Time frame: Follow-up phase - Week 12
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at week 16
Time frame: Follow-up phase - Week 16
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at week 20
Time frame: Follow-up phase - Week 20
Mean Change From Baseline in PT Value
Mean change from baseline in prothrombin time (PT) value at week 24
Time frame: Follow-up phase - Week 24
Number of Participants With Increase in Grade From Baseline for ALT Value
Number of participants with increase in grade from baseline in alanine transaminase (ALT) value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (AE) \[DAIDS AE grading table\] version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 1
Number of Participants With Increase in Grade From Baseline for ALT Value
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 2
Number of Participants With Increase in Grade From Baseline for ALT Value
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 3
Number of Participants With Increase in Grade From Baseline for ALT Value
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 4
Number of Participants With Increase in Grade From Baseline for ALT Value
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 5
Number of Participants With Increase in Grade From Baseline for ALT Value
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 8
Number of Participants With Increase in Grade From Baseline for ALT Value
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 11
Number of Participants With Increase in Grade From Baseline for ALT Value
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 16
Number of Participants With Increase in Grade From Baseline for ALT Value
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 24
Number of Participants With Increase in Grade From Baseline for ALT Value
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 28
Number of Participants With Increase in Grade From Baseline for ALT Value
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Follow-up phase - Week 8
Number of Participants With Increase in Grade From Baseline for ALT Value
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Follow-up phase - Week 12
Number of Participants With Increase in Grade From Baseline for ALT Value
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Follow-up phase - Week 16
Number of Participants With Increase in Grade From Baseline for ALT Value
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Follow-up phase - Week 20
Number of Participants With Increase in Grade From Baseline for ALT Value
Number of participants with increase in grade from baseline in alanine transaminase (ALT) value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Follow-up phase - Week 24
Number of Participants With Increase in Grade From Baseline for aPTT Value
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 1
Number of Participants With Increase in Grade From Baseline for aPTT Value
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 2
Number of Participants With Increase in Grade From Baseline for aPTT Value
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 3
Number of Participants With Increase in Grade From Baseline for aPTT Value
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 4
Number of Participants With Increase in Grade From Baseline for aPTT Value
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 5
Number of Participants With Increase in Grade From Baseline for aPTT Value
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 8
Number of Participants With Increase in Grade From Baseline for aPTT Value
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 11
Number of Participants With Increase in Grade From Baseline for aPTT Value
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 16
Number of Participants With Increase in Grade From Baseline for aPTT Value
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 24
Number of Participants With Increase in Grade From Baseline for aPTT Value
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 28
Number of Participants With Increase in Grade From Baseline for aPTT Value
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Follow-up phase - Week 8
Number of Participants With Increase in Grade From Baseline for aPTT Value
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Follow-up phase - Week 12
Number of Participants With Increase in Grade From Baseline for aPTT Value
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Follow-up phase - Week 16
Number of Participants With Increase in Grade From Baseline for aPTT Value
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Follow-up phase - Week 20
Number of Participants With Increase in Grade From Baseline for aPTT Value
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Follow-up phase - Week 24
Number of Participants With Increase in Grade From Baseline for AST Value
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 1
Number of Participants With Increase in Grade From Baseline for AST Value
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 2
Number of Participants With Increase in Grade From Baseline for AST Value
Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 3
Number of Participants With Increase in Grade From Baseline for AST Value
Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 4
Number of Participants With Increase in Grade From Baseline for AST Value
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 5
Number of Participants With Increase in Grade From Baseline for AST Value
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 8
Number of Participants With Increase in Grade From Baseline for AST Value
Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 11
Number of Participants With Increase in Grade From Baseline for AST Value
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 16
Number of Participants With Increase in Grade From Baseline for AST Value
Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 24
Number of Participants With Increase in Grade From Baseline for AST Value
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Treatment phase - Day 28
Number of Participants With Increase in Grade From Baseline for AST Value
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Follow-up phase - Week 8
Number of Participants With Increase in Grade From Baseline for AST Value
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Follow-up phase - Week 12
Number of Participants With Increase in Grade From Baseline for AST Value
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Follow-up phase - Week 16
Number of Participants With Increase in Grade From Baseline for AST Value
Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Follow-up phase - Week 20
Number of Participants With Increase in Grade From Baseline for AST Value
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
Time frame: Follow-up phase - Week 24
Number of Participants With Increase in Grade From Baseline for PT Value
Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 1
Number of Participants With Increase in Grade From Baseline for PT Value
Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 2
Number of Participants With Increase in Grade From Baseline for PT Value
Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 3
Number of Participants With Increase in Grade From Baseline for PT Value
Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 4
Number of Participants With Increase in Grade From Baseline for PT Value
Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 5
Number of Participants With Increase in Grade From Baseline for PT Value
Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 8
Number of Participants With Increase in Grade From Baseline for PT Value
Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 11
Number of Participants With Increase in Grade From Baseline for PT Value
Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 16
Number of Participants With Increase in Grade From Baseline for PT Value
Number of participants increase in grade from baseline in prothrombin time (PT) value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 24
Number of Participants With Increase in Grade From Baseline for PT Value
Number of participants increase in grade from baseline in prothrombin time (PT) value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Treatment phase - Day 28
Number of Participants With Increase in Grade From Baseline for PT Value
Number of participants increase in grade from baseline in prothrombin time (PT) value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Follow-up phase - Week 8
Number of Participants With Increase in Grade From Baseline for PT Value
Number of participants increase in grade from baseline in prothrombin time (PT) value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Follow-up phase - Week 12
Number of Participants With Increase in Grade From Baseline for PT Value
Number of participants increase in grade from baseline in prothrombin time (PT) value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Follow-up phase - Week 16
Number of Participants With Increase in Grade From Baseline for PT Value
Number of participants increase in grade from baseline in prothrombin time (PT) value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Follow-up phase - Week 20
Number of Participants With Increase in Grade From Baseline for PT Value
Number of participants increase in grade from baseline in prothrombin time (PT) value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
Time frame: Follow-up phase - Week 24
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 1
Time frame: Treatment phase - Day 1
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 2
Time frame: Treatment phase - Day 2
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 3
Time frame: Treatment phase - Day 3
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 4
Time frame: Treatment phase - Day 4
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 5
Time frame: Treatment phase - Day 5
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 8
Time frame: Treatment phase - Day 8
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 11
Time frame: Treatment phase - Day 11
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 16
Time frame: Treatment phase - Day 16
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 24
Time frame: Treatment phase - Day 24
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 28
Time frame: Treatment phase - Day 28
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 8
Time frame: Follow-up phase - Week 8
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 12
Time frame: Follow-up phase - Week 12
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 16
Time frame: Follow-up phase - Week 16
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 20
Time frame: Follow-up phase - Week 20
Participants With Grade 1 ALT Level
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 24
Time frame: Follow-up phase - Week 24
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 1
Time frame: Treatment phase - Day 1
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 2
Time frame: Treatment phase - Day 2
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 3
Time frame: Treatment phase - Day 3
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 4
Time frame: Treatment phase - Day 4
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 5
Time frame: Treatment phase - Day 5
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 8
Time frame: Treatment phase - Day 8
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 11
Time frame: Treatment phase - Day 11
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 16
Time frame: Treatment phase - Day 16
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 24
Time frame: Treatment phase - Day 24
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 28
Time frame: Treatment phase - Day 28
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 8
Time frame: Follow-up phase - Week 8
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 12
Time frame: Follow-up phase - Week 12
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 16
Time frame: Follow-up phase - Week 16
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 24
Time frame: Follow-up phase - Week 24
Participants With Grade 1 AST Level
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 28
Time frame: Follow-up phase - Week 28
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 1
Time frame: Treatment phase - Day 1
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 2
Time frame: Treatment phase - Day 2
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 3
Time frame: Treatment phase - Day 3
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 4
Time frame: Treatment phase - Day 4
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 5
Time frame: Treatment phase - Day 5
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 8
Time frame: Treatment phase - Day 8
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 11
Time frame: Treatment phase - Day 11
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 16
Time frame: Treatment phase - Day 16
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 24
Time frame: Treatment phase - Day 24
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 28
Time frame: Treatment phase - Day 28
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 8
Time frame: Follow-up phase - Week 8
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 12
Time frame: Follow-up phase - Week 12
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 16
Time frame: Follow-up phase - Week 16
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 20
Time frame: Follow-up phase - Week 20
Participants With Grade 2 ALT Level
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 24
Time frame: Follow-up phase - Week 24
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 1
Time frame: Treatment phase - Day 1
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 2
Time frame: Treatment phase - Day 2
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 3
Time frame: Treatment phase - Day 3
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 4
Time frame: Treatment phase - Day 4
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 5
Time frame: Treatment phase - Day 5
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 8
Time frame: Treatment phase - Day 8
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 11
Time frame: Treatment phase - Day 11
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 16
Time frame: Treatment phase - Day 16
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 24
Time frame: Treatment phase - Day 24
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 28
Time frame: Treatment phase - Day 28
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 8
Time frame: Follow-up phase - Week 8
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 12
Time frame: Follow-up phase - Week 12
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 16
Time frame: Follow-up phase - Week 16
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 24
Time frame: Follow-up phase - Week 24
Participants With Grade 2 AST Level
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 28
Time frame: Follow-up phase - Week 28
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 1
Time frame: Treatment phase - Day 1
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 2
Time frame: Treatment phase - Day 2
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 3
Time frame: Treatment phase - Day 3
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 4
Time frame: Treatment phase - Day 4
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 5
Time frame: Treatment phase - Day 5
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 8
Time frame: Treatment phase - Day 8
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 11
Time frame: Treatment phase - Day 11
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 16
Time frame: Treatment phase - Day 16
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 24
Time frame: Treatment phase - Day 24
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 28
Time frame: Treatment phase - Day 28
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 8
Time frame: Follow-up phase - Week 8
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 12
Time frame: Follow-up phase - Week 12
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 16
Time frame: Follow-up phase - Week 16
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 20
Time frame: Follow-up phase - Week 20
Participants With Grade 3 ALT Level
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 24
Time frame: Follow-up phase - Week 24
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 1
Time frame: Treatment phase - Day 1
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 2
Time frame: Treatment phase - Day 2
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 3
Time frame: Treatment phase - Day 3
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 4
Time frame: Treatment phase - Day 4
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 5
Time frame: Treatment phase - Day 5
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 8
Time frame: Treatment phase - Day 8
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 11
Time frame: Treatment phase - Day 11
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 16
Time frame: Treatment phase - Day 16
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 24
Time frame: Treatment phase - Day 24
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 28
Time frame: Treatment phase - Day 28
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 8
Time frame: Follow-up phase - Week 8
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 12
Time frame: Follow-up phase - Week 12
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 16
Time frame: Follow-up phase - Week 16
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 24
Time frame: Follow-up phase - Week 24
Participants With Grade 3 AST Level
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 28
Time frame: Follow-up phase - Week 28
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 1
Time frame: Treatment phase - Day 1
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 2
Time frame: Treatment phase - Day 2
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 3
Time frame: Treatment phase - Day 3
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 4
Time frame: Treatment phase - Day 4
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 5
Time frame: Treatment phase - Day 5
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 8
Time frame: Treatment phase - Day 8
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 11
Time frame: Treatment phase - Day 11
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 16
Time frame: Treatment phase - Day 16
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 24
Time frame: Treatment phase - Day 24
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 28
Time frame: Treatment phase - Day 28
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at week 8
Time frame: Follow-up phase - Week 8
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine aminotransferase (ALT) level at week 12
Time frame: Follow-up phase - Week 12
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at week 16
Time frame: Follow-up phase - Week 16
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at week 20
Time frame: Follow-up phase - Week 20
Participants With Grade 4 ALT Level
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at week 24
Time frame: Follow-up phase - Week 24
Participants With Grade 4 AST Level
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 1
Time frame: Treatment phase - Day 1
Participants With Grade 4 AST Level
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 2
Time frame: Treatment phase - Day 2
Participants With Grade 4 AST Level
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 3
Time frame: Treatment phase - Day 3
Participants With Grade 4 AST Level
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 4
Time frame: Treatment phase - Day 4
Participants With Grade 4 AST Level
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 5
Time frame: Treatment phase - Day 5
Participants With Grade 4 AST Level
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 8
Time frame: Treatment phase - Day 8
Participants With Grade 4 AST Level
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 11
Time frame: Treatment phase - Day 11
Participants With Grade 4 AST Level
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 16
Time frame: Treatment phase - Day 16
Participants With Grade 4 AST Level
Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 24
Time frame: Treatment phase - Day 24
Participants With Grade 4 AST Level
Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 28
Time frame: Treatment phase - Day 28
Participants With Grade 4 AST Level
Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 8
Time frame: Follow-up phase - Week 8
Participants With Grade 4 AST Level
Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 12
Time frame: Follow-up phase - Week 12
Participants With Grade 4 AST Level
Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 16
Time frame: Follow-up phase - Week 16
Participants With Grade 4 AST Level
Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 24
Time frame: Follow-up phase - Week 24
Participants With Grade 4 AST Level
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 28
Time frame: Follow-up phase - Week 28
| Milestone | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Started | 20 | 18 |
| Completed | 20 | 18 |
| Not completed | 0 | 0 |
Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, \& 28. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.
| proportion of semen samples | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase | 0.85 ± 0.24 | 0.76 ± 0.3 |
Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase on weeks 8, 12, 16, 20, \& 24. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.
| proportion of semen samples | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase | 0.96 ± 0.1 | 0.81 ± 0.29 |
Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, \& 28. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.
| proportion of semen samples | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase | 0.86 ± 0.24 | 0.86 ± 0.19 |
Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, \& 28. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.
| proportion of semen samples | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Assay Negativity Rate (ANR) for Ebola Virus During the Treatment Phase | 0.79 ± 0.25 | 0.28 ± 0.35 |
Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase - weeks 8, 12, 16, 20, \& 24. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.
| proportion of semen samples | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase | 0.95 ± 0.12 | 0.9 ± 0.19 |
Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase - weeks 8, 12, 16, 20, \& 24. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.
| proportion of semen samples | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Assay Negativity Rate (ANR) for Ebola Virus During the Follow-up Phase | 1 ± 0 | 0.33 ± 0.23 |
Mean change from baseline in alanine transaminase (ALT) value at day 1
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in ALT Value | 3.6 ± 11.94 | -2.22 ± 7.48 |
Mean change from baseline in alanine transaminase (ALT) value at day 2
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in ALT Value | 2.25 ± 11.61 | -0.56 ± 7.25 |
Mean change from baseline in alanine transaminase (ALT) value at day 3
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in ALT Value | 4.05 ± 12.25 | 10.28 ± 18.05 |
Mean change from baseline in alanine transaminase (ALT) value at day 4
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in ALT Value | 8.45 ± 13.2 | 11.78 ± 20.74 |
Mean change from baseline in alanine transaminase (ALT) value at day 5
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in ALT Value | 13.15 ± 14.64 | 9.22 ± 14.97 |
Mean change from baseline in alanine transaminase (ALT) value at day 8
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in ALT Value | 21.45 ± 21.09 | 4.89 ± 7.88 |
Mean change from baseline in alanine transaminase (ALT) value at day 11
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in ALT Value at Day 11 | 8.65 ± 10.91 | 1.78 ± 8.18 |
Mean change from baseline in alanine transaminase (ALT) value at day 16
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in ALT Value | 3.53 ± 9.06 | -0.06 ± 8.91 |
Mean change from baseline in alanine transaminase (ALT) value at at day 24
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in ALT Value | -0.65 ± 7.21 | -0.67 ± 6.89 |
Mean change from baseline in alanine transaminase (ALT) value at at day 28
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in ALT Value | 0.4 ± 10.08 | -2.06 ± 9.67 |
Mean change from baseline in alanine transaminase (ALT) value at week 8
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in ALT Value | -2.15 ± 6.28 | -1.22 ± 7.01 |
Mean change from baseline in alanine transaminase (ALT) Value at week 12
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in ALT Value | 3.1 ± 18.29 | -1.78 ± 8.99 |
Mean change from baseline in alanine transaminase (ALT) value at week 16
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in ALT Value | 5.95 ± 24.56 | -0.11 ± 4.56 |
Mean change from baseline in alanine transaminase (ALT) value at week 20
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in ALT Value | -1.55 ± 8.24 | -1.72 ± 8.04 |
Mean change from baseline in alanine transaminase (ALT) value at week 24
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in ALT Value | -0.89 ± 6.74 | 22.67 ± 104.56 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 1
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in aPTT Value | 0.34 ± 5.13 | 0.24 ± 2.6 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 2
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in aPTT Value | -0.9 ± 4.28 | -1.45 ± 2.04 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 3
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in aPTT Value | -0.03 ± 4.28 | -1.42 ± 3.91 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 4
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in aPTT Value | 3.82 ± 11.84 | -2.24 ± 2.29 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 5
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in aPTT Value | 1.29 ± 4.63 | -1.24 ± 4.15 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 8
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in aPTT Value | 3.92 ± 6.43 | 0.34 ± 2.84 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 11
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in aPTT Value | -1.41 ± 3.6 | -0.17 ± 2.97 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 16
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in aPTT Value | -0.18 ± 4.76 | 0.26 ± 4.33 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 24
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in aPTT Value | -0.27 ± 4.72 | 0.76 ± 4.2 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at day 28
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in aPTT Value | 0.52 ± 3.91 | 0.24 ± 5.18 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 8
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in aPTT Value | 1.16 ± 3.65 | 0.62 ± 3.67 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 12
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in aPTT Value | 0.5 ± 3.95 | 1.29 ± 3.17 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 16
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in aPTT Value | 0.78 ± 4.84 | 1.37 ± 5.22 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 20
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in aPTT Value | 1.83 ± 5.04 | 0.75 ± 6.8 |
Mean change from baseline in activated partial thromboplastin time (aPTT) value at week 24
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in aPTT Value | -0.39 ± 4.6 | 0.41 ± 4.7 |
Mean change from baseline in aspartate transaminase (AST) Value at day 1
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in AST Value | 2.45 ± 8.34 | -1.89 ± 7.38 |
Mean change from baseline in aspartate transaminase (AST) Value at day 2
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in AST Value | -0.2 ± 5.95 | 0.06 ± 5.56 |
Mean change from baseline in aspartate transaminase (AST) value at day 3
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in AST Value | 0.35 ± 6.9 | 10.39 ± 20.13 |
Mean change from baseline in aspartate transaminase (AST) value at day 4
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in AST Value | 5.6 ± 9.08 | 5.72 ± 15.94 |
Mean change from baseline in aspartate transaminase (AST) value at day 5
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in AST Value | 8.15 ± 9.35 | 2.44 ± 9.51 |
Mean change from baseline in aspartate transaminase (AST) value at day 8
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in AST Value | 9.4 ± 12.83 | 1.39 ± 7.69 |
Mean change from baseline in aspartate transaminase (AST) value at day 11
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in AST Value | 0.2 ± 6.87 | -0.22 ± 8.14 |
Mean change from baseline in aspartate transaminase (AST) value at day 16
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in AST Value | -1.42 ± 5.34 | -0.89 ± 8.38 |
Mean change from baseline in aspartate transaminase (AST) value at day 24
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in AST Value | -1.25 ± 5.22 | 0.67 ± 6.89 |
Mean change from baseline in aspartate transaminase (AST) value at day 28
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in AST Value | 0.85 ± 8.6 | -0.83 ± 9.4 |
Mean change from baseline in aspartate transaminase (AST) value at week 8
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in AST Value | -1.7 ± 5.16 | 1.39 ± 7.91 |
Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 12
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in AST Value | 5.85 ± 24.54 | 1 ± 8.25 |
Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 16
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in AST Value | 11.4 ± 36.51 | 1.39 ± 4.35 |
Mean change from baseline in aspartate aminotransferase transaminase (AST) value at week 20
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in AST Value | -0.95 ± 8.91 | -0.67 ± 8.25 |
Mean change from baseline in aspartate transaminase (AST) value at week 24
| IU/L | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in AST Value | -1.05 ± 6.03 | 11.61 ± 51.06 |
Mean change from baseline in international normalized ratio (INR) value at day 1
| Ratio | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in INR Value | 0.02 ± 0.15 | 0 ± 0.13 |
Mean change from baseline in international normalized ratio (INR) value at day 2
| Ratio | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in INR Value | 0.01 ± 0.08 | -0.01 ± 0.14 |
Mean change from baseline in international normalized ratio (INR) value at day 3
| Ratio | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in INR Value | 0.03 ± 0.07 | -0.03 ± 0.14 |
Mean change from baseline in international normalized ratio (INR) value at day 4
| Ratio | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in INR Value | 1.04 ± 4.16 | -0.06 ± 0.15 |
Mean change from baseline in international normalized ratio (INR) value at day 5
| Ratio | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in INR Value | 0.13 ± 0.07 | -0.05 ± 0.16 |
Mean change from baseline in international normalized ratio (INR) value at day 8
| Ratio | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in INR Value | 0.12 ± 0.16 | -0.05 ± 0.15 |
Mean change from baseline in international normalized ratio (INR) value at day 11
| Ratio | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in INR Value | 0.05 ± 0.18 | -0.03 ± 0.14 |
Mean change from baseline in international normalized ratio (INR) value at day 16
| Ratio | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in INR Value | 0.05 ± 0.19 | -0.05 ± 0.13 |
Mean change from baseline in international normalized ratio (INR) value at day 24
| Ratio | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in INR Value | 0.06 ± 0.22 | -0.04 ± 0.15 |
Mean change from baseline in international normalized ratio (INR) value at day 28
| Ratio | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in INR Value | 0.01 ± 0.21 | -0.03 ± 0.19 |
Mean change from baseline in international normalized ratio (INR) value at week 8
| Ratio | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in INR Value | -0.01 ± 0.24 | -0.18 ± 0.21 |
Mean change from baseline in international normalized ratio (INR) value at week 12
| Ratio | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in INR Value | 0.04 ± 0.2 | -0.06 ± 0.27 |
Mean change from baseline in international normalized ratio (INR) value at week 16
| Ratio | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in INR Value | 0.09 ± 0.2 | -0.05 ± 0.24 |
Mean change from baseline in international normalized ratio (INR) value at week 20
| Ratio | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in INR Value | -0.05 ± 0.3 | -0.16 ± 0.26 |
Mean change from baseline in international normalized ratio (INR) value at week 24
| Ratio | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in INR Value | -0.1 ± 0.31 | -0.28 ± 0.2 |
Mean change from baseline in prothrombin time (PT) value at day 1
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in PT Value | -0.13 ± 0.51 | 0.22 ± 0.41 |
Mean change from baseline in prothrombin time (PT) value at day 2
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in PT Value | 0.09 ± 0.71 | 0.13 ± 0.51 |
Mean change from baseline in prothrombin time (PT) value at day 3
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in PT Value | 0.28 ± 0.62 | -0.01 ± 0.62 |
Mean change from baseline in prothrombin time (PT) value at day 4
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in PT Value | 6.27 ± 23.42 | -0.24 ± 0.5 |
Mean change from baseline in prothrombin time (PT) value at day 5
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in PT Value | 1.28 ± 0.6 | -0.13 ± 0.6 |
Mean change from baseline in prothrombin time (PT) value at day 8
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in PT Value | 0.86 ± 0.76 | -0.11 ± 0.65 |
Mean change from baseline in prothrombin time (PT) value at day 11
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in PT Value | -0.08 ± 0.56 | 0.04 ± 0.71 |
Mean change from baseline in prothrombin time (PT) value at day 16
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in PT Value | -0.13 ± 0.84 | -0.17 ± 0.56 |
Mean change from baseline in prothrombin time (PT) value at day 24
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in PT Value | -0.1 ± 0.78 | -0.07 ± 0.58 |
Mean change from baseline in prothrombin time (PT) value at day 28
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in PT Value | -0.34 ± 0.75 | 0.11 ± 0.61 |
Mean change from baseline in prothrombin time (PT) value at week 8
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in PT Value | -0.26 ± 0.59 | -0.27 ± 0.57 |
Mean change from baseline in prothrombin time (PT) value at week 12
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in PT Value | -0.22 ± 0.74 | 0.06 ± 0.59 |
Mean change from baseline in prothrombin time (PT) value at week 16
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in PT Value | -0.17 ± 0.59 | -0.03 ± 0.54 |
Mean change from baseline in prothrombin time (PT) value at week 20
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in PT Value | -0.25 ± 0.7 | 0.26 ± 0.81 |
Mean change from baseline in prothrombin time (PT) value at week 24
| Seconds | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Mean Change From Baseline in PT Value | -0.41 ± 0.90 | -0.23 ± 0.6 |
Number of participants with increase in grade from baseline in alanine transaminase (ALT) value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (AE) \[DAIDS AE grading table\] version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for ALT Value | 1 | 0 |
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for ALT Value | 1 | 0 |
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for ALT Value | 1 | 0 |
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for ALT Value | 1 | 3 |
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for ALT Value | 2 | 2 |
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for ALT Value | 5 | 0 |
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for ALT Value | 3 | 0 |
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for ALT Value | 1 | 0 |
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for ALT Value | 1 | 0 |
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for ALT Value | 0 | 0 |
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for ALT Value | 0 | 0 |
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for ALT Value | 1 | 0 |
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for ALT Value | 1 | 0 |
Number of participants with increase in grade from baseline in alanine transaminase (ALT) Value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for ALT Value | 0 | 0 |
Number of participants with increase in grade from baseline in alanine transaminase (ALT) value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). ALT grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for ALT Value | 1 | 1 |
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for aPTT Value | 1 | 0 |
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for aPTT Value | 0 | 0 |
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for aPTT Value | 1 | 1 |
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for aPTT Value | 5 | 0 |
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for aPTT Value | 2 | 0 |
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for aPTT Value | 2 | 0 |
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for aPTT Value | 0 | 0 |
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for aPTT Value | 1 | 0 |
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for aPTT Value | 1 | 1 |
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for aPTT Value | 0 | 0 |
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for aPTT Value | 1 | 1 |
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for aPTT Value | 1 | 1 |
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for aPTT Value | 1 | 2 |
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for aPTT Value | 1 | 2 |
Number of participants with increase in grade from baseline in activated partial thromboplastin time (aPTT) value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). aPTT grade ranges include grade 1 (1.1 - 1.66 x ULN), grade 2 (1.67 - 2.33 x ULN), grade 3 (2.34 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for aPTT Value | 0 | 1 |
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for AST Value | 0 | 0 |
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for AST Value | 0 | 0 |
Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for AST Value | 1 | 4 |
Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for AST Value | 1 | 1 |
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for AST Value | 1 | 1 |
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for AST Value | 3 | 0 |
Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for AST Value | 0 | 0 |
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for AST Value | 0 | 0 |
Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for AST Value | 0 | 0 |
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for AST Value | 0 | 0 |
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for AST Value | 0 | 1 |
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for AST Value | 1 | 0 |
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for AST Value | 2 | 0 |
Number of participants with increase in grade from baseline in aspartate transaminase (AST) value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for AST Value | 1 | 0 |
Number of participants with increase in grade from baseline in aspartate transaminase (AST) Value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). AST grade ranges include grade 1 (1.25-2.5 x ULN), grade 2 (2.6-5.0 x ULN), grade 3 (5.1-10.0 x ULN), \& grade 4 (\> 10 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for AST Value | 1 | 1 |
Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 1. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for PT Value | 0 | 0 |
Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 2. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for PT Value | 0 | 0 |
Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 3. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for PT Value | 0 | 0 |
Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 4. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for PT Value | 2 | 0 |
Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 5. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for PT Value | 1 | 0 |
Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for PT Value | 0 | 0 |
Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 11. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for PT Value | 0 | 0 |
Number of participants with increase in grade from baseline in prothrombin time (PT) value at day 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for PT Value | 0 | 0 |
Number of participants increase in grade from baseline in prothrombin time (PT) value at day 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for PT Value | 0 | 0 |
Number of participants increase in grade from baseline in prothrombin time (PT) value at day 28. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for PT Value | 0 | 0 |
Number of participants increase in grade from baseline in prothrombin time (PT) value at week 8. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for PT Value | 0 | 0 |
Number of participants increase in grade from baseline in prothrombin time (PT) value at week 12. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for PT Value | 0 | 0 |
Number of participants increase in grade from baseline in prothrombin time (PT) value at week 16. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for PT Value | 0 | 0 |
Number of participants increase in grade from baseline in prothrombin time (PT) value at week 20. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for PT Value | 0 | 1 |
Number of participants increase in grade from baseline in prothrombin time (PT) value at week 24. Lab values were graded using Division of Acquired Immunodeficiency Syndrome (DAIDS) table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE grading table) version 2.0, November 2014 with grade 1 (mild), grade 2 (moderate), grade 3 (severe), and grade 4 (potentially life-threatening). PT grade ranges include grade 1 (1.1 - 1.25 x ULN), grade 2 (1.26 - 1.50 x ULN), grade 3 (1.51 - 3.00 x ULN), \& grade 4 (\> 3.00 x ULN)
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Number of Participants With Increase in Grade From Baseline for PT Value | 0 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 1
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 ALT Level | 1 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 2
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 ALT Level | 1 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 3
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 ALT Level | 1 | 5 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 4
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 ALT Level | 1 | 3 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 5
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 ALT Level | 2 | 2 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 8
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 ALT Level | 4 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 11
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 ALT Level | 3 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 16
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 ALT Level | 1 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 24
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 ALT Level | 1 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at day 28
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 ALT Level | 0 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 8
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 ALT Level | 0 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 12
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 ALT Level | 1 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 16
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 ALT Level | 0 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 20
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 ALT Level | 0 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) alanine transaminase (ALT) level at week 24
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 ALT Level | 1 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 1
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 AST Level | 0 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 2
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 AST Level | 0 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 3
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 AST Level | 1 | 4 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 4
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 AST Level | 1 | 1 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 5
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 AST Level | 1 | 1 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 8
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 AST Level | 3 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 11
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 AST Level | 0 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 16
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 AST Level | 0 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 24
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 AST Level | 0 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at day 28
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 AST Level | 0 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 8
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 AST Level | 0 | 1 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 12
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 AST Level | 0 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 16
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 AST Level | 0 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 24
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 AST Level | 1 | 0 |
Participants with grade 1 (1.25 - 2.5 x ULN) aspartate transaminase (AST) level at week 28
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 1 AST Level | 1 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 1
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 ALT Level | 1 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 2
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 ALT Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 3
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 ALT Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 4
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 ALT Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 5
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 ALT Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 8
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 ALT Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 11
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 ALT Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 16
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 ALT Level | 1 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 24
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 ALT Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at day 28
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 ALT Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 8
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 ALT Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 12
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 ALT Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 16
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 ALT Level | 1 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 20
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 ALT Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) alanine transaminase (ALT) level at week 24
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 ALT Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 1
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 AST Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 2
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 AST Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 3
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 AST Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 4
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 AST Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 5
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 AST Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 8
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 AST Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 11
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 AST Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 16
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 AST Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 24
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 AST Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at day 28
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 AST Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 8
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 AST Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 12
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 AST Level | 1 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 16
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 AST Level | 2 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 24
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 AST Level | 0 | 0 |
Participants with grade 2 (2.6 - 5.0 x ULN) aspartate transaminase (AST) level at week 28
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 2 AST Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 1
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 ALT Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 2
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 ALT Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 3
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 ALT Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 4
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 ALT Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 5
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 ALT Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 8
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 ALT Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 11
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 ALT Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 16
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 ALT Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 24
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 ALT Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at day 28
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 ALT Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 8
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 ALT Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 12
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 ALT Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 16
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 ALT Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 20
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 ALT Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) alanine transaminase (ALT) level at week 24
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 ALT Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 1
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 AST Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 2
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 AST Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 3
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 AST Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 4
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 AST Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 5
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 AST Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 8
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 AST Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 11
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 AST Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 16
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 AST Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 24
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 AST Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at day 28
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 AST Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 8
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 AST Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 12
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 AST Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 16
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 AST Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 24
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 AST Level | 0 | 0 |
Participants with grade 3 (5.1 - 10.0 x ULN) aspartate transaminase (AST) level at week 28
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 3 AST Level | 0 | 1 |
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 1
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 ALT Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 2
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 ALT Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 3
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 ALT Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 4
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 ALT Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 5
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 ALT Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 8
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 ALT Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 11
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 ALT Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 16
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 ALT Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 24
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 ALT Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at day 28
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 ALT Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at week 8
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 ALT Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) alanine aminotransferase (ALT) level at week 12
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 ALT Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at week 16
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 ALT Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at week 20
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 ALT Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) alanine transaminase (ALT) level at week 24
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 ALT Level | 0 | 1 |
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 1
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 AST Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 2
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 AST Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 3
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 AST Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 4
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 AST Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 5
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 AST Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 8
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 AST Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 11
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 AST Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 16
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 AST Level | 0 | 0 |
Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 24
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 AST Level | 0 | 0 |
Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at day 28
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 AST Level | 0 | 0 |
Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 8
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 AST Level | 0 | 0 |
Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 12
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 AST Level | 0 | 0 |
Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 16
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 AST Level | 0 | 0 |
Proportion of grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 24
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 AST Level | 0 | 0 |
Participants with grade 4 (\> 10 x ULN) aspartate transaminase (AST) level at week 28
| Participants | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Participants With Grade 4 AST Level | 0 | 0 |
Collected over 24 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GS-5734 100mg Given Intravenously Daily for 5 Days | 0/20 (0%) | 0/20 (0%) | 15/20 (75%) |
| Normal Saline Given Intravenously Daily for 5 Days | 0/18 (0%) | 0/18 (0%) | 15/18 (83.3%) |
| Event | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days |
|---|---|---|
| Decreased appetiteMetabolism and nutrition disorders | 2/20 | 7/18 |
| HeadacheNervous system disorders | 4/20 | 7/18 |
| DiarrhoeaGastrointestinal disorders | 2/20 | 5/18 |
| Infusion site painGeneral disorders | 3/20 | 5/18 |
| NauseaGastrointestinal disorders | 5/20 | 4/18 |
| Back painMusculoskeletal and connective tissue disorders | 2/20 | 4/18 |
| RashSkin and subcutaneous tissue disorders | 2/20 | 4/18 |
| DizzinessCardiac disorders | 1/20 | 2/18 |
| ConstipationGastrointestinal disorders | 0/20 | 2/18 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/20 | 2/18 |
| Age, Categorical(Participants) | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 18 | 38 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 20 | 18 | 38 |
| Ethnicity (NIH/OMB)(Participants) | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 20 | 18 | 38 |
| Race (NIH/OMB)(Participants) | GS-5734 100mg Given Intravenously Daily for 5 Days | Normal Saline Given Intravenously Daily for 5 Days | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 20 | 18 | 38 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2016 to primary completion in Aug 2020, 49 months.
Results were first posted in Feb 2022, 1 year 5 months after primary completion.
Of 13 phase 2 interventional studies under Hemorrhagic Fever, Ebola, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 39. This study's 49 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Remdesivir
National Institute of Allergy and Infectious Diseases (NIAID) →