A Phase 2 interventional study of GSK1265744 10 mg and GSK1265744 30 mg in Infection, Human Immunodeficiency Virus and HIV Infections, sponsored by ViiV Healthcare. Completed at 48 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-30.
Sponsored by ViiV Healthcare · Phase 2, Interventional, and Treatment
The study is designed to select a dose of GSK1265744 primarily on the basis of antiviral activity and tolerability in HIV-1 infected, antiretroviral naive subjects.
This study consists of two parts:
Induction Phase: Approximately 200 subjects will be randomized (50 subjects in each of the 4 treatment arms). The Induction Phase consists of a 24 week dose-ranging evaluation of GSK1265744 at blinded doses of 10 mg, 30 mg and 60 mg once-daily and a control arm of open-label efavirenz (EFV) 600 mg once daily. The background dual nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral therapy (ART) for all arms will be either abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC) as selected by the Investigator. Subjects randomized to a GSK1265744 containing arm, who successfully complete 24 weeks on study and demonstrate virologic suppression (defined as having a plasma HIV-1 ribonucleic acid [RNA] \<50 copies per milliliter [c/mL] before Week 24, with no signs of virologic rebound) will become eligible for the Maintenance Phase of this study.
Maintenance Phase: The background NRTIs will be discontinued and the subjects will continue their randomized dose of GSK1265744 in combination with rilpivirine (RPV) 25 mg once-daily for an additional 72 weeks. The Maintenance phase will evaluate the ability of this two drug ART regimen to maintain virologic suppression through Week 48, Week 72 and Week 96. Subjects randomized to the EFV arm will continue on their randomized regimen through Week 96.
After completion of the maintenance phase, subjects could enroll in the Open-Label Phase to continue GSK1265744 + RPV treatment as long as they continue to derive clinical benefit and until it is locally approved and commercially available.
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 244 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In the Induction Phase subjects will receive oral tablets of GSK1265744 10 mg + matching placebo + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine) once daily from Day 1 to Week 24. Subjects continuing in the Maintenance Phase will receive oral tablets of GSK1265744 10 mg + matching placebo + Rilpivirine 25 mg once daily from Week 24 to Week 96.
Drug: GSK1265744 10 mg · Drug: Rilpivirine 25 mg · Drug: Placebo · Drug: Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
In the Induction Phase subjects will receive oral tablets of GSK1265744 30 mg + matching placebo + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine) once daily from Day 1 to Week 24. Subjects continuing in the Maintenance Phase will receive oral tablets of GSK1265744 30 mg + matching placebo + Rilpivirine 25 mg once daily from Week 24 to Week 96.
Drug: GSK1265744 30 mg · Drug: Rilpivirine 25 mg · Drug: Placebo · Drug: Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
In the Induction Phase subjects will receive oral tablets of GSK1265744 60 mg + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine) once daily from Day 1 to Week 24. Subjects continuing in the Maintenance Phase will receive oral tablets of GSK1265744 60 mg + Rilpivirine 25 mg once daily from Week 24 to Week 96.
Drug: GSK1265744 60 mg · Drug: Rilpivirine 25 mg · Drug: Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
In the Induction Phase and Maintenance Phase subjects will receive oral tablets of Efavirenz 600 mg + investigator-selected background NRTIs (either abacavir/lamivudine or tenofovir/emtricitabine).
Drug: Efavirenz 600 mg · Drug: Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
GSK1265744 10 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
GSK1265744 30 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
GSK1265744 60 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
Efavirenz 600 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase and Maintenance Phase of the study.
Rilpivirine 25 mg will be administered orally once daily in combination with GSK1265744 10 mg, 30 mg and 60 mg in the Maintenance Phase of the study.
Placebo matching to GSK1265744 will be administered along with GSK1265744 10 mg and 30 mg in the Induction phase and Maintenance phase of the study.
The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator.
Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 was determined using the MSDF algorithm based on the current US Food and Drug Administration (FDA) definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-E Population comprised of all randomized participants who received at least one dose of investigational product.
Time frame: Week 48
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with HIV-1 RNA \<400 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<400 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on randomized therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease
HIV-1 associated conditions were assessed according to the 1993 Centers for Disease Control and Prevention (CDC) Revised Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death.
Time frame: Up to Week 324
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96
CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Change From Baseline in CD4+ Cell Count Over Time by Visit
CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Number of Participants With Treatment Emergent Phenotypic Resistance
Plasma samples were collected for drug resistance testing. Phenotypic resistance data for the following drugs under integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), NRTI and proteasome inhibitor drug classes is presented for participants with confirmed virologic failure: GSK1265744, Raltegravir \[RAL\], Delavirdine \[DLV\], Efavirenz \[EFV\], Etravirine \[ETR\], Nevirapine (NVP), RPV, 3TC, ABC, FTC, TDF, Zidovudine \[ZDV\], Stavudine \[d4T\], Didanosine \[ddI\], Atazanavir/ritonavir \[ATV/r\], Darunavir (DRV)/r, Fosamprenavir/r \[FPV/r\], Indinavir/r \[IDV/r\], Lopinavir/r \[LPV/r\], Nelfinavir \[NFV\], Ritonavir \[RTV\], Saquinavir/r \[SQV/r\], Tipranavir/r \[TPV/r\]. On-treatment Phenotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data, excluding participants who are not protocol-defined virologic failures.
Time frame: Up to Week 324
Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance
Plasma samples were collected for drug resistance testing. The treatment emergent INI mutations associated with development of resistance to RAL, ELV, dolutegravir (DTG) or GSK1265744 and major resistance mutations to other classes (NRTI, NNRTI, PI) as defined by International AIDS society (IAS)-United States of America (USA) are presented. On-treatment Genotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment genotypic resistance data, excluding participants who are not protocol-defined virologic failures.
Time frame: Up to Week 324
Number of Participants With Adherence to Study Treatment
Number of participants with \>=90% adherence to study treatment based on pill count is summarized.
Time frame: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
Time frame: Week 16 and Week 24
Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The end point was determined using MSDF algorithm based on the current US FDA definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-Maintenance Exposed (ME) Population comprised of all participants randomized to GSK1265744 and who received at least one dose of investigational product during maintenance phase of the study.
Time frame: Weeks 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Maintenance Safety Population comprised of all participants randomized to GSK1265744 and who were exposed to investigational products during the maintenance phase of the study with the exception of any participants with documented evidence of not having consumed any amount of investigational product.
Time frame: Week 24 to Week 96
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase
Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotranferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), carbon dioxide(CO2)/bicarbonate, cholesterol, creatine kinase (CK), creatinine, glucose, low density lipoprotein (LDL) cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Time frame: Week 24 to Week 96
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase
Blood samples were collected for the analysis of following hematology parameters: Activated Partial Thromboplastin Time (APTT), hemoglobin, international normalized ratio (INR), platelet count, prothrombin time (PT), total neutrophils and white blood cell (WBC) count. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Time frame: Week 24 to Week 96
Number of Participants With AEs and SAEs Over Time
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Safety Population comprised of all randomized participants who were exposed to investigational products with the exception of any participants with documented evidence of not having consumed any amount of investigational product.
Time frame: Up to Week 324
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time
Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, cholesterol, CK, creatinine, glucose, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Time frame: Up to Week 324
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time
Blood samples were collected for the analysis of following hematology parameters: APTT, hemoglobin, INR, platelet count, PT, total neutrophils and WBC count. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Time frame: Up to Week 324
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of creatinine and total bilirubin (T. bilirubin). Baseline value is the last pre-treatment value observed.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of platelet count, total neutrophils (T. neutrophils) and WBC count. Baseline value is the last pre-treatment value observed.
Time frame: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Change From Baseline in ALT, AST and CK Over Time by Visit
Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit
Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264
Change From Baseline in Hemoglobin Level Over Time by Visit
Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit
Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
Time frame: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.
Time frame: Up to Week 324
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Twelve lead ECG was performed after the participants had rested in a semi-supine position for at least 5 minutes using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst case results at any time on-treatment is presented.
Time frame: Up to Week 324
Number of Participants With AEs and SAEs-Induction Phase
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia.
Time frame: Up to Week 24
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase
Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, chloride, cholesterol, CK, creatinine, glucose, high density lipoprotein (HDL) cholesterol, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin, triglycerides and urea/blood urea nitrogen (BUN). A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Time frame: Up to Week 24
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase
Blood samples were collected for the analysis of following hematology parameters: APTT, basophils, eosinophils, hematocrit, hemoglobin, INR, lymphocytes, mean corpuscle volume (MCV), monocytes, platelet count, PT, red blood cell (RBC) count, total neutrophils and WBC count. A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
Time frame: Up to Week 24
Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.
Time frame: Up to Week 24
Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.
Time frame: Week 24 to Week 96
Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2
Blood samples for pharmacokinetic (PK) analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. The PK Summary Population comprised of all participants who received GSK1265744 or with Rilpivirine, underwent intensive and/or limited/sparse PK sampling during the study, and provided evaluable GSK1265744 and Rilpivirine plasma concentration data
Time frame: pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2
Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2
Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2
Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2
Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
Time frame: pre-dose, 1, 2, 3, 4, 8 and 24 hours post dose at Week 2
AUC(0 to Tau) for Rilpivirine
Data was not collected for analysis of rilpivirine PK parameters.
Time frame: pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36
Cmax for Rilpivirine
Data was not collected for analysis of rilpivirine PK parameters.
Time frame: pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36
Ctau for Rilpivirine
Data was not collected for analysis of rilpivirine PK parameters.
Time frame: pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36
This was a multicenter, two part study in human immunodeficiency virus-1 (HIV-1) infected antiretroviral therapy (ART) naïve adult participants conducted across 48 sites in the United States (US) and Canada.
| Milestone | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Started | 60 | 60 | 61 | 62 |
| Completed | 52 | 53 | 55 | 47 |
| Not completed | 8 | 7 | 6 | 15 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 | 1 |
| Withdrew: Physician decision | 0 | 1 | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 2 | 0 | 3 |
| Withdrew: Protocol violation | 2 | 1 | 1 | 0 |
| Withdrew: Lack of efficacy | 4 | 1 | 2 | 3 |
| Withdrew: Adverse event | 0 | 1 | 3 | 7 |
| Milestone | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Started | 52 | 53 | 55 | 47 |
| Completed | 46 | 48 | 52 | 41 |
| Not completed | 6 | 5 | 3 | 6 |
| Withdrew: Withdrawal by subject | 2 | 3 | 1 | 0 |
| Withdrew: Physician decision | 0 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 | 1 | 2 |
| Withdrew: Lack of efficacy | 1 | 1 | 0 | 2 |
| Withdrew: Adverse event | 1 | 0 | 1 | 2 |
| Milestone | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Started | 46 | 47 | 51 | 0 |
| Completed | 30 | 35 | 43 | 0 |
| Not completed | 16 | 12 | 8 | 0 |
| Withdrew: Withdrawal by subject | 2 | 3 | 1 | 0 |
| Withdrew: Physician decision | 0 | 1 | 1 | 0 |
| Withdrew: Lost to follow-up | 5 | 4 | 5 | 0 |
| Withdrew: Site closed | 1 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 1 | 0 | 0 |
| Withdrew: Lack of efficacy | 4 | 1 | 0 | 0 |
| Withdrew: Adverse event | 3 | 2 | 1 | 0 |
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 was determined using the MSDF algorithm based on the current US Food and Drug Administration (FDA) definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-E Population comprised of all randomized participants who received at least one dose of investigational product.
| Percentage of participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm | 80 (70 to 90) | 80 (70 to 90) | 87 (78 to 95) | 71 (60 to 82) |
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with HIV-1 RNA \<400 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
| Percentage of participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Baseline | 0 | 0 | 0 | 0 |
| Week 2 | 87 | 80 | 84 | 68 |
| Week 4 | 93 | 93 | 93 | 68 |
| Week 8 | 93 | 92 | 92 | 79 |
| Week 12 | 90 | 85 | 89 | 73 |
| Week 16 | 93 | 87 | 93 | 81 |
| Week 24 | 93 | 87 | 92 | 79 |
| Week 26 | 80 | 80 | 87 | 71 |
| Week 28 | 85 | 83 | 85 | 73 |
| Week 32 | 87 | 85 | 89 | 73 |
| Week 36 | 87 | 85 | 90 | 73 |
| Week 40 | 87 | 85 | 90 | 73 |
| Week 48 | 83 | 85 | 89 | 73 |
| Week 60 | 80 | 77 | 87 | 71 |
| Week 72 | 77 | 75 | 85 | 68 |
| Week 84 | 77 | 77 | 85 | 68 |
| Week 96 | 75 | 77 | 85 | 65 |
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<400 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on randomized therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period.
| Percentage of participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Baseline; n=60, 60, 61, 62 | 0 | 0 | 0 | 0 |
| Week 2; n=57, 56, 59, 59 | 91 | 86 | 86 | 71 |
| Week 4; n=58, 57, 59, 57 | 97 | 98 | 97 | 74 |
| Week 8; n=59, 56, 57, 55 | 95 | 98 | 98 | 91 |
| Week 12; n=58, 52, 57, 51 | 97 | 100 | 98 | 92 |
| Week 16; n=57, 54, 57, 52 | 98 | 100 | 100 | 96 |
| Week 20; n=56, 54, 56, 47 | 100 | 100 | 100 | 100 |
| Week 24; n=56, 53, 56, 48 | 100 | 100 | 100 | 100 |
| Week 26; n=48, 50, 53, 44 | 100 | 100 | 100 | 100 |
| Week 28; n=51, 52, 52, 45 | 100 | 100 | 100 | 100 |
| Week 32; n=52, 53, 55, 45 | 100 | 100 | 98 | 100 |
| Week 36; n=52, 53, 55, 45 | 100 | 100 | 100 | 100 |
| Week 40; n=52, 53, 55, 45 | 100 | 100 | 100 | 100 |
| Week 48; n=51, 53, 54, 44 | 98 | 98 | 100 | 100 |
| Week 60; n=48, 48, 53, 44 | 96 | 100 | 100 | 98 |
| Week 72; n=47, 48, 52, 42 | 98 | 96 | 100 | 100 |
| Week 84; n=46, 48, 52, 42 | 100 | 98 | 100 | 100 |
| Week 96; n=45, 48, 52, 40 | 96 | 100 | 100 | 100 |
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
| Percentage of participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Baseline | 0 | 0 | 0 | 0 |
| Week 2 | 48 | 50 | 51 | 13 |
| Week 4 | 80 | 78 | 70 | 24 |
| Week 8 | 90 | 83 | 87 | 48 |
| Week 12 | 88 | 75 | 82 | 61 |
| Week 16 | 90 | 83 | 87 | 74 |
| Week 24 | 87 | 85 | 87 | 74 |
| Week 26 | 78 | 75 | 85 | 66 |
| Week 28 | 85 | 78 | 85 | 69 |
| Week 32 | 83 | 80 | 87 | 69 |
| Week 36 | 85 | 82 | 85 | 71 |
| Week 40 | 83 | 82 | 85 | 68 |
| Week 48 | 80 | 80 | 87 | 71 |
| Week 60 | 78 | 73 | 85 | 68 |
| Week 72 | 72 | 73 | 85 | 68 |
| Week 84 | 72 | 75 | 85 | 68 |
| Week 96 | 68 | 75 | 84 | 63 |
| Week 108 | 68 | 72 | 80 | 0 |
| Week 120 | 65 | 73 | 80 | 0 |
| Week 132 | 62 | 70 | 80 | 0 |
| Week 144 | 58 | 67 | 77 | 0 |
| Week 156 | 58 | 63 | 80 | 0 |
| Week 168 | 57 | 65 | 75 | 0 |
| Week 180 | 58 | 67 | 75 | 0 |
| Week 192 | 57 | 65 | 74 | 0 |
| Week 204 | 55 | 62 | 75 | 0 |
| Week 216 | 55 | 63 | 77 | 0 |
| Week 228 | 53 | 63 | 75 | 0 |
| Week 240 | 50 | 62 | 74 | 0 |
| Week 252 | 52 | 62 | 75 | 0 |
| Week 264 | 53 | 62 | 75 | 0 |
| Week 276 | 52 | 62 | 70 | 0 |
| Week 288 | 50 | 62 | 74 | 0 |
| Week 300 | 52 | 60 | 70 | 0 |
| Week 312 | 52 | 52 | 70 | 0 |
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase.
| Percentage of participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Baseline; n=60, 60, 61, 62 | 0 | 0 | 0 | 0 |
| Week 2; n=57, 56, 59, 59 | 51 | 54 | 53 | 14 |
| Week 4; n=58, 57, 59, 57 | 83 | 82 | 73 | 26 |
| Week 8; n=59, 56, 57, 55 | 92 | 89 | 93 | 55 |
| Week 12; n=58, 52, 57, 51 | 95 | 88 | 91 | 76 |
| Week 16; n=57, 54, 57, 52 | 95 | 94 | 93 | 87 |
| Week 20; n=56, 54, 56, 47 | 91 | 98 | 98 | 91 |
| Week 24; n=56, 53, 56, 48 | 93 | 98 | 95 | 96 |
| Week 26; n=48, 50, 53, 44 | 98 | 94 | 98 | 93 |
| Week 28; n=51, 52, 52, 45 | 100 | 94 | 100 | 96 |
| Week 32; n=52, 53, 55, 45 | 96 | 94 | 96 | 96 |
| Week 36; n=52, 53, 55, 45 | 98 | 96 | 95 | 98 |
| Week 40; n=52, 53, 55, 45 | 96 | 96 | 95 | 93 |
| Week 48; n=51, 53, 54, 44 | 92 | 92 | 98 | 98 |
| Week 60; n=48, 48, 53, 44 | 94 | 96 | 98 | 95 |
| Week 72; n=47, 48, 52, 42 | 91 | 92 | 100 | 100 |
| Week 84; n=46, 48, 52, 42 | 91 | 94 | 100 | 100 |
| Week 96; n=45, 48, 52, 40 | 89 | 98 | 98 | 98 |
| Week 108; n=43, 46, 49, 0 | 95 | 96 | 100 | — |
| Week 120; n=41, 46, 49, 0 | 95 | 100 | 98 | — |
| Week 132; n=40, 46, 49, 0 | 95 | 96 | 100 | — |
| Week 144; n=37, 45, 47, 0 | 92 | 93 | 98 | — |
| Week 156; n=37, 42, 49, 0 | 95 | 95 | 98 | — |
| Week 168; n=35, 43, 47, 0 | 94 | 95 | 98 | — |
| Week 180; n=36, 41, 47, 0 | 97 | 100 | 98 | — |
| Week 192; n=36, 40, 47, 0 | 94 | 100 | 96 | — |
| Week 204; n=34, 39, 47, 0 | 97 | 97 | 98 | — |
| Week 216; n=33, 39, 47, 0 | 100 | 100 | 98 | — |
| Week 228; n=32, 39, 47, 0 | 100 | 100 | 98 | — |
| Week 240; n=31, 39, 45, 0 | 97 | 97 | 100 | — |
| Week 252; n=31, 38, 47, 0 | 100 | 97 | 98 | — |
| Week 264; n=32, 38, 47, 0 | 100 | 100 | 98 | — |
| Week 276; n=31, 38, 45, 0 | 100 | 100 | 96 | — |
| Week 288; n=30, 38, 45, 0 | 100 | 100 | 100 | — |
| Week 300; n=31, 37, 44, 0 | 97 | 100 | 95 | — |
| Week 312; n=31, 33, 43, 0 | 100 | 97 | 100 | — |
| Week 324; n=3, 4, 3, 0 | 100 | 100 | 100 | — |
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed.
| Log10 copies per milliliter | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Baseline; n=60, 60, 61, 62 | 4.424 ± 0.5834 | 4.270 ± 0.6359 | 4.428 ± 0.6418 | 4.290 ± 0.6683 |
| Week 2; n=57, 56, 59, 59 | 1.883 ± 0.4551 | 1.984 ± 0.5786 | 1.939 ± 0.5071 | 2.415 ± 0.5717 |
| Week 4; n=58, 57, 59, 57 | 1.706 ± 0.3245 | 1.731 ± 0.4141 | 1.725 ± 0.2750 | 2.201 ± 0.5780 |
| Week 8; n=59, 56, 57, 55 | 1.695 ± 0.4114 | 1.666 ± 0.3676 | 1.666 ± 0.3926 | 1.950 ± 0.5636 |
| Week 12; n=58, 52, 57, 51 | 1.643 ± 0.2506 | 1.618 ± 0.0786 | 1.641 ± 0.2033 | 1.758 ± 0.4082 |
| Week 16; n=57, 54, 57, 52 | 1.619 ± 0.1418 | 1.602 ± 0.0354 | 1.616 ± 0.0956 | 1.697 ± 0.3277 |
| Week 20; n=56, 54, 56, 47 | 1.623 ± 0.1175 | 1.596 ± 0.0346 | 1.599 ± 0.0591 | 1.649 ± 0.1962 |
| Week 24; n=56, 53, 56, 48 | 1.615 ± 0.1010 | 1.597 ± 0.0360 | 1.603 ± 0.0532 | 1.610 ± 0.0902 |
| Week 26; n=48, 50, 53, 44 | 1.595 ± 0.0270 | 1.602 ± 0.0434 | 1.594 ± 0.0194 | 1.610 ± 0.0742 |
| Week 28; n=51, 52, 52, 45 | 1.591 ± 0.0000 | 1.607 ± 0.0565 | 1.591 ± 0.0000 | 1.600 ± 0.0451 |
| Week 32; n=52, 53, 55, 45 | 1.609 ± 0.0955 | 1.620 ± 0.1277 | 1.618 ± 0.1742 | 1.614 ± 0.1022 |
| Week 36; n=52, 53, 55, 45 | 1.604 ± 0.0782 | 1.610 ± 0.1070 | 1.606 ± 0.0722 | 1.607 ± 0.1068 |
| Week 40; n=52, 53, 55, 45 | 1.612 ± 0.1206 | 1.618 ± 0.1214 | 1.608 ± 0.0752 | 1.607 ± 0.0650 |
| Week 48; n=51, 53, 54, 44 | 1.686 ± 0.4077 | 1.654 ± 0.3673 | 1.598 ± 0.0508 | 1.596 ± 0.0247 |
| Week 60; n=48, 48, 53, 44 | 1.648 ± 0.2643 | 1.598 ± 0.0300 | 1.594 ± 0.0205 | 1.657 ± 0.3948 |
| Week 72; n=47, 48, 52, 42 | 1.625 ± 0.1584 | 1.697 ± 0.4705 | 1.591 ± 0.0000 | 1.592 ± 0.0065 |
| Week 84; n=46, 48, 52, 42 | 1.645 ± 0.1838 | 1.643 ± 0.2896 | 1.592 ± 0.0059 | 1.591 ± 0.0017 |
| Week 96; n=45, 48, 52, 40 | 1.681 ± 0.2783 | 1.603 ± 0.0861 | 1.596 ± 0.0227 | 1.598 ± 0.0467 |
| Week 108; n=43, 46, 49, 0 | 1.634 ± 0.1979 | 1.609 ± 0.0885 | 1.591 ± 0.0000 | — |
| Week 120; n=41, 46, 49, 0 | 1.638 ± 0.2216 | 1.591 ± 0.0000 | 1.618 ± 0.1884 | — |
| Week 132; n=40, 46, 49, 0 | 1.646 ± 0.2491 | 1.631 ± 0.2097 | 1.591 ± 0.0000 | — |
| Week 144; n=37, 45, 47, 0 | 1.682 ± 0.4027 | 1.698 ± 0.5940 | 1.630 ± 0.2656 | — |
| Week 156; n=37, 42, 49, 0 | 1.634 ± 0.1850 | 1.603 ± 0.0520 | 1.619 ± 0.1833 | — |
| Week 168; n=35, 43, 47, 0 | 1.665 ± 0.3351 | 1.642 ± 0.2908 | 1.603 ± 0.0810 | — |
| Week 180; n=36, 41, 47, 0 | 1.613 ± 0.1324 | 1.591 ± 0.0000 | 1.600 ± 0.0584 | — |
| Week 192; n=36, 40, 47, 0 | 1.689 ± 0.4119 | 1.591 ± 0.0000 | 1.699 ± 0.6971 | — |
| Week 204; n=34, 39, 47, 0 | 1.628 ± 0.2162 | 1.595 ± 0.0252 | 1.634 ± 0.2936 | — |
| Week 216; n=33, 39, 47, 0 | 1.591 ± 0.0000 | 1.592 ± 0.0052 | 1.634 ± 0.2948 | — |
| Week 228; n=32, 39, 47, 0 | 1.591 ± 0.0000 | 1.591 ± 0.0000 | 1.625 ± 0.2351 | — |
| Week 240; n=31, 39, 45, 0 | 1.596 ± 0.0268 | 1.601 ± 0.0465 | 1.591 ± 0.0000 | — |
| Week 252; n=31, 38, 47, 0 | 1.591 ± 0.0000 | 1.599 ± 0.0461 | 1.593 ± 0.0157 | — |
| Week 264; n=32, 38, 47, 0 | 1.591 ± 0.0000 | 1.591 ± 0.0000 | 1.617 ± 0.1788 | — |
| Week 276; n=31, 38, 45, 0 | 1.591 ± 0.0000 | 1.591 ± 0.0000 | 1.618 ± 0.1398 | — |
| Week 288; n=30, 38, 45, 0 | 1.591 ± 0.000 | 1.592 ± 0.0052 | 1.591 ± 0.0000 | — |
| Week 300; n=31, 37, 44, 0 | 1.601 ± 0.0551 | 1.591 ± 0.0000 | 1.625 ± 0.1753 | — |
| Week 312; n=31, 33, 43, 0 | 1.597 ± 0.0214 | 1.600 ± 0.0494 | 1.591 ± 0.0000 | — |
| Week 324; n=3, 4, 3, 0 | 1.591 ± 0.0000 | 1.591 ± 0.0000 | 1.591 ± 0.0000 | — |
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
| Log10 copies per milliliter | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Week 2; n=57, 56, 59, 59 | -2.534 ± 0.4175 | -2.306 ± 0.5937 | -2.504 ± 0.4311 | -1.875 ± 0.4273 |
| Week 4; n=58, 57, 59, 57 | -2.731 ± 0.4158 | -2.550 ± 0.6300 | -2.718 ± 0.4981 | -2.092 ± 0.4866 |
| Week 8; n=59, 56, 57, 55 | -2.733 ± 0.6374 | -2.611 ± 0.6938 | -2.741 ± 0.7034 | -2.344 ± 0.6765 |
| Week 12; n=58, 52, 57, 51 | -2.793 ± 0.5574 | -2.634 ± 0.6308 | -2.790 ± 0.6515 | -2.533 ± 0.6580 |
| Week 16; n=57, 54, 57, 52 | -2.823 ± 0.5118 | -2.659 ± 0.6363 | -2.815 ± 0.6170 | -2.602 ± 0.6698 |
| Week 20; n=56, 54, 56, 47 | -2.823 ± 0.5329 | -2.665 ± 0.6418 | -2.834 ± 0.6250 | -2.666 ± 0.6512 |
| Week 24; n=56, 53, 56, 48 | -2.831 ± 0.5465 | -2.659 ± 0.6488 | -2.830 ± 0.6304 | -2.694 ± 0.6843 |
| Week 26; n=48, 50, 53, 44 | -2.788 ± 0.5023 | -2.662 ± 0.6670 | -2.792 ± 0.6014 | -2.733 ± 0.6879 |
| Week 28; n=51, 52, 52, 45 | -2.784 ± 0.4944 | -2.663 ± 0.6356 | -2.791 ± 0.5831 | -2.714 ± 0.6873 |
| Week 32; n=52, 53, 55, 45 | -2.763 ± 0.5164 | -2.636 ± 0.6598 | -2.781 ± 0.6146 | -2.672 ± 0.6812 |
| Week 36; n=52, 53, 55, 45 | -2.768 ± 0.5000 | -2.646 ± 0.6786 | -2.792 ± 0.5803 | -2.679 ± 0.6776 |
| Week 40; n=52, 53, 55, 45 | -2.760 ± 0.5143 | -2.638 ± 0.6581 | -2.790 ± 0.5736 | -2.679 ± 0.6817 |
| Week 48; n=51, 53, 54, 44 | -2.682 ± 0.6637 | -2.602 ± 0.7855 | -2.799 ± 0.5946 | -2.676 ± 0.6773 |
| Week 60; n=48, 48, 53, 44 | -2.729 ± 0.6405 | -2.613 ± 0.6068 | -2.787 ± 0.5920 | -2.615 ± 0.8875 |
| Week 72; n=47, 48, 52, 42 | -2.745 ± 0.5229 | -2.514 ± 0.7487 | -2.783 ± 0.6009 | -2.738 ± 0.6415 |
| Week 84; n=46, 48, 52, 42 | -2.722 ± 0.5650 | -2.568 ± 0.7144 | -2.782 ± 0.5994 | -2.739 ± 0.6431 |
| Week 96; n=45, 48, 52, 40 | -2.670 ± 0.5277 | -2.608 ± 0.6342 | -2.778 ± 0.5943 | -2.731 ± 0.6586 |
| Week 108; n=43, 46, 49, 0 | -2.723 ± 0.5396 | -2.632 ± 0.6265 | -2.743 ± 0.5851 | — |
| Week 120; n=41, 46, 49, 0 | -2.712 ± 0.5477 | -2.650 ± 0.6137 | -2.717 ± 0.6180 | — |
| Week 132; n=40, 46, 49, 0 | -2.705 ± 0.5504 | -2.610 ± 0.6718 | -2.743 ± 0.5851 | — |
| Week 144; n=37, 45, 47, 0 | -2.690 ± 0.6615 | -2.555 ± 0.9008 | -2.703 ± 0.6903 | — |
| Week 156; n=37, 42, 49, 0 | -2.737 ± 0.5476 | -2.645 ± 0.6129 | -2.716 ± 0.6309 | — |
| Week 168; n=35, 43, 47, 0 | -2.680 ± 0.6170 | -2.592 ± 0.7138 | -2.700 ± 0.5907 | — |
| Week 180; n=36, 41, 47, 0 | -2.747 ± 0.4984 | -2.628 ± 0.6251 | -2.767 ± 0.5672 | — |
| Week 192; n=36, 40, 47, 0 | -2.671 ± 0.6656 | -2.641 ± 0.6272 | -2.667 ± 0.8708 | — |
| Week 204; n=34, 39, 47, 0 | -2.750 ± 0.5359 | -2.632 ± 0.6353 | -2.718 ± 0.7294 | — |
| Week 216; n=33, 39, 47, 0 | -2.787 ± 0.4956 | -2.636 ± 0.6337 | -2.718 ± 0.6660 | — |
| Week 228; n=32, 39, 47, 0 | -2.770 ± 0.4940 | -2.636 ± 0.6346 | -2.726 ± 0.6757 | — |
| Week 240; n=31, 39, 45, 0 | -2.798 ± 0.4923 | -2.627 ± 0.6181 | -2.736 ± 0.5861 | — |
| Week 252; n=31, 38, 47, 0 | -2.787 ± 0.5092 | -2.601 ± 0.6209 | -2.758 ± 0.5875 | — |
| Week 264; n=32, 38, 47, 0 | -2.780 ± 0.5022 | -2.659 ± 0.6264 | -2.734 ± 0.6213 | — |
| Week 276; n=31, 38, 45, 0 | -2.786 ± 0.5095 | -2.659 ± 0.6264 | -2.764 ± 0.6002 | — |
| Week 288; n=30, 38, 45, 0 | -2.768 ± 0.5083 | -2.659 ± 0.6246 | -2.775 ± 0.5984 | — |
| Week 300; n=31, 37, 44, 0 | -2.776 ± 0.5062 | -2.664 ± 0.6344 | -2.730 ± 0.6786 | — |
| Week 312; n=31, 33, 43, 0 | -2.780 ± 0.5085 | -2.569 ± 0.6037 | -2.789 ± 0.5825 | — |
| Week 324; n=3, 4, 3, 0 | -2.488 ± 0.1409 | -2.215 ± 0.4624 | -2.438 ± 0.5904 | — |
HIV-1 associated conditions were assessed according to the 1993 Centers for Disease Control and Prevention (CDC) Revised Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death.
| Participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| CDC Class A to CDC Class C | 1 | 1 | 0 | 0 |
| CDC Class B to CDC Class C | 0 | 0 | 0 | 0 |
| CDC Class C to new CDC Class C | 0 | 0 | 0 | 0 |
| CDC Class A, B or C to Death | 0 | 1 | 1 | 0 |
CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed.
| Cells per cubic millimeter | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Baseline; n=60, 60, 61, 62 | 445.5 ± 155.60 | 444.9 ± 190.98 | 459.0 ± 170.64 | 456.5 ± 196.11 |
| Week 2; n=57, 56, 59, 59 | 544.0 ± 197.54 | 525.1 ± 181.29 | 549.3 ± 206.68 | 487.0 ± 222.84 |
| Week 4; n=58, 57, 59, 57 | 580.5 ± 230.40 | 522.0 ± 205.80 | 545.8 ± 196.79 | 509.9 ± 198.21 |
| Week 8; n=58, 56, 57, 55 | 576.6 ± 196.55 | 555.2 ± 210.92 | 544.3 ± 176.01 | 531.4 ± 175.95 |
| Week 12; n=58, 53, 57, 51 | 588.4 ± 208.15 | 599.0 ± 226.06 | 596.6 ± 181.00 | 564.3 ± 222.99 |
| Week 16; n=57, 54, 57, 52 | 608.3 ± 200.34 | 595.8 ± 197.47 | 599.7 ± 166.77 | 594.4 ± 212.63 |
| Week 20; n=56, 54, 56, 49 | 607.3 ± 204.87 | 607.4 ± 199.27 | 636.6 ± 225.04 | 607.7 ± 186.36 |
| Week 24; n=56, 53, 56, 47 | 614.6 ± 194.13 | 626.5 ± 210.63 | 658.0 ± 253.19 | 599.5 ± 219.52 |
| Week 26; n=48, 50, 53, 45 | 632.8 ± 210.93 | 629.5 ± 207.34 | 645.8 ± 188.61 | 625.7 ± 196.46 |
| Week 28; n=49, 52, 52, 45 | 652.2 ± 225.32 | 635.9 ± 217.52 | 653.3 ± 261.11 | 635.7 ± 224.72 |
| Week 32; n=52, 53, 55, 45 | 638.1 ± 192.54 | 650.8 ± 209.66 | 665.2 ± 246.84 | 663.8 ± 257.25 |
| Week 36; n=52, 53, 55, 45 | 638.7 ± 198.05 | 658.6 ± 226.51 | 720.3 ± 257.85 | 651.5 ± 212.15 |
| Week 40; n=52, 53, 55, 45 | 650.2 ± 218.40 | 658.5 ± 204.08 | 667.6 ± 187.30 | 687.9 ± 241.35 |
| Week 48; n=51, 53, 54, 44 | 677.3 ± 219.75 | 687.2 ± 227.06 | 713.8 ± 215.70 | 732.6 ± 273.19 |
| Week 60; n=48, 47, 53, 44 | 668.1 ± 222.61 | 720.9 ± 268.74 | 719.8 ± 219.04 | 733.9 ± 238.90 |
| Week 72; n=47, 48, 52, 42 | 683.2 ± 242.75 | 651.3 ± 217.19 | 710.9 ± 259.89 | 722.5 ± 263.47 |
| Week 84; n=46, 48, 52, 42 | 718.3 ± 212.59 | 736.9 ± 271.85 | 735.0 ± 236.25 | 744.7 ± 250.90 |
| Week 96; n=46, 46, 52, 41 | 726.2 ± 272.28 | 722.9 ± 246.22 | 743.1 ± 242.23 | 747.8 ± 263.27 |
CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
| Cells per cubic millimeter | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Week 2; n=57, 56, 59, 59 | 92.6 ± 112.44 | 79.5 ± 118.15 | 91.7 ± 127.92 | 24.8 ± 138.47 |
| Week 4; n=58, 57, 59, 57 | 136.4 ± 157.36 | 76.9 ± 107.01 | 88.2 ± 110.01 | 46.0 ± 106.35 |
| Week 8; n=58, 56, 57, 55 | 129.9 ± 123.47 | 117.8 ± 132.19 | 90.5 ± 148.25 | 65.6 ± 120.25 |
| Week 12; n=58, 53, 57, 51 | 140.5 ± 142.86 | 140.8 ± 165.02 | 145.2 ± 142.24 | 103.4 ± 125.39 |
| Week 16; n=57, 54, 57, 52 | 159.3 ± 115.36 | 142.2 ± 145.64 | 148.3 ± 131.81 | 135.5 ± 153.48 |
| Week 20; n=56, 54, 56, 49 | 165.2 ± 146.90 | 153.8 ± 150.40 | 182.6 ± 142.18 | 149.0 ± 117.44 |
| Week 24; n=56, 53, 56, 47 | 172.5 ± 112.04 | 180.9 ± 161.43 | 204.0 ± 166.78 | 143.4 ± 145.18 |
| Week 26; n=48, 50, 53, 45 | 186.4 ± 153.99 | 177.7 ± 146.84 | 194.7 ± 149.66 | 166.4 ± 145.11 |
| Week 28; n=49, 52, 52, 45 | 205.0 ± 164.91 | 188.1 ± 132.08 | 193.3 ± 154.43 | 178.2 ± 150.25 |
| Week 32; n=52, 53, 55, 45 | 191.4 ± 151.79 | 205.2 ± 145.53 | 209.9 ± 157.56 | 197.4 ± 170.48 |
| Week 36; n=52, 53, 55, 45 | 192.0 ± 165.97 | 213.0 ± 144.89 | 265.0 ± 169.42 | 185.2 ± 152.91 |
| Week 40; n=52, 53, 55, 45 | 203.6 ± 171.74 | 212.8 ± 180.38 | 212.3 ± 114.67 | 221.5 ± 188.99 |
| Week 48; n=51, 53, 54, 44 | 235.1 ± 179.89 | 241.6 ± 182.90 | 259.0 ± 154.21 | 262.5 ± 201.33 |
| Week 60; n=48, 47, 53, 44 | 217.7 ± 152.92 | 269.4 ± 188.34 | 266.1 ± 156.03 | 263.8 ± 181.15 |
| Week 72; n=47, 48, 52, 42 | 232.0 ± 191.05 | 201.4 ± 206.54 | 254.0 ± 189.26 | 257.1 ± 216.41 |
| Week 84; n=46, 48, 52, 42 | 261.5 ± 171.65 | 287.0 ± 207.10 | 278.1 ± 166.11 | 279.4 ± 191.30 |
| Week 96; n=46, 46, 52, 41 | 269.4 ± 204.32 | 267.5 ± 196.27 | 286.2 ± 181.50 | 281.7 ± 232.90 |
| Week 108; n=43, 46, 49, 0 | 296.2 ± 215.21 | 304.3 ± 195.30 | 288.4 ± 184.61 | — |
| Week 120; n=41, 46, 49, 0 | 266.1 ± 173.09 | 279.3 ± 181.10 | 307.2 ± 225.39 | — |
| Week 132; n=40, 46, 49, 0 | 297.1 ± 167.59 | 305.2 ± 184.98 | 313.2 ± 168.30 | — |
| Week 144; n=37, 45, 46, 0 | 330.7 ± 225.42 | 308.9 ± 224.63 | 322.4 ± 224.57 | — |
| Week 156; n=37, 42, 49, 0 | 334.5 ± 213.79 | 319.2 ± 182.15 | 320.4 ± 187.58 | — |
| Week 168; n=35, 43, 47, 0 | 338.1 ± 252.13 | 332.4 ± 222.37 | 361.3 ± 198.98 | — |
| Week 180; n=36, 41, 47, 0 | 338.0 ± 218.72 | 348.6 ± 203.73 | 384.2 ± 192.86 | — |
| Week 192; n=35, 40, 47, 0 | 300.8 ± 168.24 | 351.0 ± 205.56 | 342.3 ± 204.83 | — |
| Week 204; n=34, 39, 47, 0 | 369.5 ± 196.17 | 332.9 ± 179.28 | 340.0 ± 191.82 | — |
| Week 216; n=33, 39, 47, 0 | 397.0 ± 202.03 | 373.4 ± 188.28 | 357.8 ± 199.87 | — |
| Week 228; n=32, 39, 47, 0 | 331.8 ± 168.64 | 366.5 ± 231.25 | 383.7 ± 253.17 | — |
| Week 240; n=32, 39, 47, 0 | 356.5 ± 195.99 | 395.9 ± 205.55 | 408.4 ± 201.05 | — |
| Week 252; n=31, 38, 47, 0 | 400.3 ± 183.36 | 343.7 ± 196.09 | 383.1 ± 217.20 | — |
| Week 264; n=32, 38, 47, 0 | 344.4 ± 160.38 | 365.0 ± 210.00 | 391.8 ± 222.00 | — |
| Week 276; n=31, 38, 46, 0 | 398.3 ± 250.45 | 350.3 ± 210.98 | 362.2 ± 243.30 | — |
| Week 288; n=30, 38, 45, 0 | 411.0 ± 161.93 | 383.5 ± 279.75 | 337.1 ± 187.13 | — |
| Week 300; n=30, 37, 44, 0 | 437.7 ± 196.33 | 404.4 ± 239.11 | 353.5 ± 200.23 | — |
| Week 312; n=30, 34, 43, 0 | 335.0 ± 176.73 | 433.0 ± 264.63 | 407.0 ± 178.06 | — |
| Week 324; n=3, 4, 3, 0 | 402.0 ± 197.55 | 276.0 ± 278.28 | 272.0 ± 277.44 | — |
Plasma samples were collected for drug resistance testing. Phenotypic resistance data for the following drugs under integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), NRTI and proteasome inhibitor drug classes is presented for participants with confirmed virologic failure: GSK1265744, Raltegravir \[RAL\], Delavirdine \[DLV\], Efavirenz \[EFV\], Etravirine \[ETR\], Nevirapine (NVP), RPV, 3TC, ABC, FTC, TDF, Zidovudine \[ZDV\], Stavudine \[d4T\], Didanosine \[ddI\], Atazanavir/ritonavir \[ATV/r\], Darunavir (DRV)/r, Fosamprenavir/r \[FPV/r\], Indinavir/r \[IDV/r\], Lopinavir/r \[LPV/r\], Nelfinavir \[NFV\], Ritonavir \[RTV\], Saquinavir/r \[SQV/r\], Tipranavir/r \[TPV/r\]. On-treatment Phenotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data, excluding participants who are not protocol-defined virologic failures.
| Participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| INI, GSK1265744; Resistant; n=5, 1, 2, 2 | 2 | 0 | 1 | 0 |
| INI, GSK1265744; Sensitive; n=5, 1, 2, 2 | 3 | 1 | 1 | 2 |
| INI, RAL; Resistant; n=5, 1, 2, 2 | 3 | 0 | 1 | 0 |
| INI, RAL; Sensitive; n=5, 1, 2, 2 | 2 | 1 | 1 | 2 |
| NNRTI, DLV; Resistant; n=6, 2, 2, 5 | 3 | 0 | 0 | 0 |
| NNRTI, DLV; Sensitive; n=6, 2, 2, 5 | 3 | 2 | 2 | 5 |
| NNRTI, EFV; Resistant; n=6, 2, 2, 5 | 3 | 0 | 0 | 0 |
| NNRTI, EFV; Sensitive; n=6, 2, 2, 5 | 3 | 2 | 2 | 5 |
| NNRTI, ETR; Resistant; n=6, 2, 2, 5 | 3 | 0 | 0 | 0 |
| NNRTI, ETR; Partially sensitive; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| NNRTI, ETR; Sensitive; n=6, 2, 2, 5 | 3 | 2 | 2 | 5 |
| NNRTI, NVP; Resistant; n=6, 2, 2, 5 | 3 | 0 | 0 | 0 |
| NNRTI, NVP; Sensitive; n=6, 2, 2, 5 | 3 | 2 | 2 | 5 |
| NNRTI, RPV; Resistant; n=6, 2, 2, 5 | 3 | 0 | 0 | 0 |
| NNRTI, RPV; Sensitive; n=6, 2, 2, 5 | 3 | 2 | 2 | 5 |
| NRTI, 3TC; Resistant; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| NRTI, 3TC; Sensitive; n=6, 2, 2, 5 | 6 | 2 | 2 | 5 |
| NRTI, ABC; Resistant; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| NRTI, ABC; Partially sensitive; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| NRTI, ABC; Sensitive; n=6, 2, 2, 5 | 6 | 2 | 2 | 5 |
| NRTI, FTC; Resistant; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| NRTI, FTC; Sensitive; n=6, 2, 2, 5 | 6 | 2 | 2 | 5 |
| NRTI, TDF; Resistant; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| NRTI, TDF; Partially sensitive; n=6, 2, 2, 5 | 1 | 0 | 0 | 0 |
| NRTI, TDF; Sensitive; n=6, 2, 2, 5 | 5 | 2 | 2 | 5 |
| NRTI, ZDV; Resistant; n=6, 2, 2, 5 | 2 | 0 | 0 | 0 |
| NRTI, ZDV; Sensitive; n=6, 2, 2, 5 | 4 | 2 | 2 | 5 |
| NRTI, d4T; Resistant; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| NRTI, d4T; Sensitive; n=6, 2, 2, 5 | 6 | 2 | 2 | 5 |
| NRTI, ddI; Resistant; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| NRTI, ddI; Partially sensitive; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| NRTI, ddI; Sensitive; n=6, 2, 2, 5 | 6 | 2 | 2 | 5 |
| PI, ATV/r; Resistant; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| PI, ATV/r; Sensitive; n=6, 2, 2, 5 | 6 | 2 | 2 | 5 |
| PI, DRV/r; Resistant; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| PI, DRV/r; Partially sensitive; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| PI, DRV/r; Sensitive; n=6, 2, 2, 5 | 6 | 2 | 2 | 5 |
| PI, FPV/r; Resistant; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| PI, FPV/r; Partially sensitive; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| PI, FPV/r; Sensitive; n=6, 2, 2, 5 | 6 | 2 | 2 | 5 |
| PI, IDV/r; Resistant; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| PI, IDV/r; Sensitive; n=6, 2, 2, 5 | 6 | 2 | 2 | 5 |
| PI, LPV/r; Resistant; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| PI, LPV/r; Partially sensitive; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| PI, LPV/r; Sensitive; n=6, 2, 2, 5 | 6 | 2 | 2 | 5 |
| PI, NFV; Resistant; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| PI, NFV; Sensitive; n=6, 2, 2, 5 | 6 | 2 | 2 | 5 |
| PI, RTV; Resistant; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| PI, RTV; Sensitive; n=6, 2, 2, 5 | 6 | 2 | 2 | 5 |
| PI, SQV/r; Resistant; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| PI, SQV/r; Partially sensitive; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| PI, SQV/r; Sensitive; n=6, 2, 2, 5 | 6 | 2 | 2 | 5 |
| PI, TPV/r; Resistant; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| PI, TPV/r; Partially sensitive; n=6, 2, 2, 5 | 0 | 0 | 0 | 0 |
| PI, TPV/r; Sensitive; n=6, 2, 2, 5 | 6 | 2 | 2 | 5 |
Plasma samples were collected for drug resistance testing. The treatment emergent INI mutations associated with development of resistance to RAL, ELV, dolutegravir (DTG) or GSK1265744 and major resistance mutations to other classes (NRTI, NNRTI, PI) as defined by International AIDS society (IAS)-United States of America (USA) are presented. On-treatment Genotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment genotypic resistance data, excluding participants who are not protocol-defined virologic failures.
| Participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Any INI mutation | 3 | 0 | 1 | 0 |
| Any mutation to other classes | 4 | 0 | 1 | 0 |
Number of participants with \>=90% adherence to study treatment based on pill count is summarized.
| Participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Baseline; n=57, 55, 56, 52 | 53 | 51 | 55 | 48 |
| Week 4; n=54, 52, 53, 50 | 46 | 49 | 52 | 44 |
| Week 8; n=53, 50, 56, 48 | 49 | 45 | 53 | 47 |
| Week 12; n=55, 48, 53, 48 | 44 | 40 | 46 | 43 |
| Week 16; n=53, 51, 53, 44 | 44 | 45 | 50 | 42 |
| Week 20; n=51, 49, 55, 44 | 45 | 40 | 51 | 41 |
| Week 24; n=51, 46, 51, 43 | 47 | 41 | 48 | 39 |
| Week 28; n=49, 48, 53, 41 | 45 | 46 | 48 | 35 |
| Week 32; n=47, 48, 55, 41 | 46 | 42 | 52 | 37 |
| Week 36; n=46, 48, 50, 41 | 40 | 43 | 48 | 36 |
| Week 40; n=38, 35, 45, 39 | 33 | 30 | 41 | 34 |
| Week 48; n=33, 37, 45, 35 | 32 | 33 | 41 | 33 |
| Week 60; n=38, 38, 40, 37 | 37 | 35 | 37 | 35 |
| Week 72; n=35, 37, 44, 32 | 32 | 35 | 41 | 27 |
| Week 84; n=36, 39, 42, 33 | 34 | 36 | 39 | 29 |
| Week 96; n=31, 36, 33, 0 | 25 | 32 | 30 | — |
| Week 108; n=23, 23, 29, 0 | 21 | 20 | 27 | — |
| Week 120; n=30, 38, 41, 0 | 28 | 36 | 39 | — |
| Week 132; n=29, 32, 40, 0 | 28 | 30 | 35 | — |
| Week 144; n=33, 34, 43, 0 | 32 | 29 | 41 | — |
| Week 156; n=31, 28, 39, 0 | 30 | 25 | 35 | — |
| Week 168; n=29, 33, 41, 0 | 29 | 24 | 35 | — |
| Week 180; n=26, 29, 39, 0 | 24 | 24 | 34 | — |
| Week 192; n=30, 30, 39, 0 | 28 | 27 | 35 | — |
| Week 204; n=29, 32, 38, 0 | 27 | 26 | 33 | — |
| Week 216; n=29, 30, 37, 0 | 29 | 27 | 31 | — |
| Week 228; n=27, 34, 40, 0 | 25 | 28 | 35 | — |
| Week 240; n=28, 26, 41, 0 | 28 | 22 | 35 | — |
| Week 252; n=23, 26, 33, 0 | 18 | 21 | 29 | — |
| Week 264; n=15, 18, 24, 0 | 12 | 16 | 21 | — |
| Week 276; n=14, 14, 21, 0 | 13 | 13 | 18 | — |
| Week 288; n=12, 14, 18, 0 | 12 | 10 | 17 | — |
| Week 300; n=12, 13, 20, 0 | 11 | 7 | 18 | — |
| Week 312; n=1, 1, 0, 0 | 1 | 1 | — | — |
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA \<50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.
| Percentage of participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Week 16 | 90 (82 to 98) | 83 (74 to 93) | 87 (78 to 95) | 74 (63 to 85) |
| Week 24 | 87 (78 to 95) | 85 (76 to 94) | 87 (78 to 95) | 74 (63 to 85) |
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The end point was determined using MSDF algorithm based on the current US FDA definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-Maintenance Exposed (ME) Population comprised of all participants randomized to GSK1265744 and who received at least one dose of investigational product during maintenance phase of the study.
| Percentage of participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Week 24 | 96 | 94 | 96 | 96 |
| Week 26 | 90 | 85 | 95 | 87 |
| Week 28 | 98 | 89 | 95 | 91 |
| Week 32 | 96 | 91 | 96 | 91 |
| Week 36 | 98 | 92 | 95 | 94 |
| Week 40 | 96 | 92 | 95 | 89 |
| Week 48 | 92 | 91 | 96 | 94 |
| Week 60 | 90 | 83 | 95 | 89 |
| Week 72 | 83 | 83 | 95 | 89 |
| Week 84 | 83 | 85 | 95 | 89 |
| Week 96 | 79 | 85 | 93 | 83 |
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Maintenance Safety Population comprised of all participants randomized to GSK1265744 and who were exposed to investigational products during the maintenance phase of the study with the exception of any participants with documented evidence of not having consumed any amount of investigational product.
| Participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Any AE | 40 | 50 | 50 | 35 |
| Any SAE | 5 | 5 | 5 | 2 |
Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotranferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), carbon dioxide(CO2)/bicarbonate, cholesterol, creatine kinase (CK), creatinine, glucose, low density lipoprotein (LDL) cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
| Participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| ALT; Grade 1 | 9 | 12 | 17 | 6 |
| ALT; Grade 2 | 6 | 6 | 5 | 3 |
| ALT; Grade 3 | 0 | 1 | 0 | 0 |
| ALT; Grade 4 | 1 | 1 | 0 | 1 |
| Albumin; Grade 1 | 0 | 1 | 0 | 0 |
| Albumin; Grade 2 | 0 | 0 | 0 | 0 |
| Albumin; Grade 3 | 0 | 0 | 0 | 0 |
| Albumin; Grade 4 | 0 | 0 | 0 | 0 |
| ALP; Grade 1 | 2 | 1 | 4 | 4 |
| ALP; Grade 2 | 0 | 1 | 0 | 0 |
| ALP; Grade 3 | 0 | 0 | 0 | 0 |
| ALP; Grade 4 | 0 | 0 | 0 | 0 |
| AST; Grade 1 | 5 | 13 | 13 | 5 |
| AST; Grade 2 | 5 | 8 | 5 | 2 |
| AST; Grade 3 | 2 | 0 | 2 | 3 |
| AST; Grade 4 | 2 | 1 | 0 | 2 |
| CO2/bicarbonate; Grade 1 | 6 | 14 | 9 | 8 |
| CO2/bicarbonate; Grade 2 | 1 | 0 | 0 | 1 |
| CO2/bicarbonate; Grade 3 | 0 | 0 | 0 | 0 |
| CO2/bicarbonate; Grade 4 | 0 | 0 | 0 | 0 |
| Cholesterol; Grade 1 | 17 | 17 | 19 | 9 |
| Cholesterol; Grade 2 | 6 | 12 | 15 | 10 |
| Cholesterol; Grade 3 | 3 | 0 | 3 | 4 |
| Cholesterol; Grade 4 | 0 | 0 | 0 | 0 |
| CK; Grade 1 | 8 | 9 | 11 | 5 |
| CK; Grade 2 | 2 | 4 | 4 | 0 |
| CK; Grade 3 | 3 | 2 | 4 | 3 |
| CK; Grade 4 | 6 | 6 | 5 | 5 |
| Creatinine; Grade 1 | 1 | 1 | 2 | 1 |
| Creatinine; Grade 2 | 1 | 0 | 0 | 0 |
| Creatinine; Grade 3 | 0 | 0 | 0 | 0 |
| Creatinine; Grade 4 | 0 | 0 | 0 | 0 |
| Glucose; Grade 1 | 17 | 17 | 20 | 11 |
| Glucose; Grade 2 | 14 | 10 | 11 | 5 |
| Glucose; Grade 3 | 0 | 0 | 2 | 0 |
| Glucose; Grade 4 | 0 | 0 | 0 | 0 |
| LDL cholesterol; Grade 1 | 14 | 16 | 13 | 8 |
| LDL cholesterol; Grade 2 | 6 | 11 | 14 | 6 |
| LDL cholesterol; Grade 3 | 4 | 2 | 7 | 4 |
| LDL cholesterol; Grade 4 | 0 | 0 | 0 | 0 |
| Lipase; Grade 1 | 9 | 9 | 8 | 9 |
| Lipase; Grade 2 | 9 | 8 | 11 | 7 |
| Lipase; Grade 3 | 5 | 1 | 6 | 0 |
| Lipase; Grade 4 | 2 | 0 | 2 | 0 |
| Inorganic phosphorus; Grade 1 | 5 | 3 | 9 | 7 |
| Inorganic phosphorus; Grade 2 | 10 | 11 | 5 | 9 |
| Inorganic phosphorus; Grade 3 | 2 | 1 | 5 | 2 |
| Inorganic phosphorus; Grade 4 | 0 | 0 | 0 | 0 |
| Potassium; Grade 1 | 12 | 7 | 8 | 4 |
| Potassium; Grade 2 | 0 | 0 | 0 | 1 |
| Potassium; Grade 3 | 0 | 0 | 0 | 0 |
| Potassium; Grade 4 | 0 | 0 | 0 | 0 |
| Sodium; Grade 1 | 14 | 12 | 16 | 7 |
| Sodium; Grade 2 | 2 | 1 | 0 | 1 |
| Sodium; Grade 3 | 0 | 0 | 0 | 0 |
| Sodium; Grade 4 | 0 | 0 | 0 | 0 |
| Total bilirubin; Grade 1 | 7 | 1 | 8 | 0 |
| Total bilirubin; Grade 2 | 2 | 3 | 4 | 0 |
| Total bilirubin; Grade 3 | 0 | 1 | 0 | 0 |
| Total bilirubin; Grade 4 | 0 | 0 | 0 | 0 |
| Triglycerides; Grade 1 | 0 | 0 | 0 | 0 |
| Triglycerides; Grade 2 | 1 | 4 | 3 | 1 |
| Triglycerides; Grade 3 | 1 | 0 | 3 | 1 |
| Triglycerides; Grade 4 | 0 | 0 | 1 | 0 |
Blood samples were collected for the analysis of following hematology parameters: Activated Partial Thromboplastin Time (APTT), hemoglobin, international normalized ratio (INR), platelet count, prothrombin time (PT), total neutrophils and white blood cell (WBC) count. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
| Participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| APTT; Grade 1 | 5 | 5 | 5 | 5 |
| APTT; Grade 2 | 0 | 1 | 0 | 0 |
| APTT; Grade 3 | 0 | 0 | 0 | 0 |
| APTT; Grade 4 | 1 | 1 | 1 | 1 |
| Hemoglobin; Grade 1 | 0 | 0 | 0 | 0 |
| Hemoglobin; Grade 2 | 1 | 0 | 0 | 0 |
| Hemoglobin; Grade 3 | 0 | 0 | 0 | 0 |
| Hemoglobin; Grade 4 | 0 | 0 | 0 | 0 |
| INR; Grade 1 | 2 | 4 | 0 | 3 |
| INR; Grade 2 | 0 | 1 | 1 | 1 |
| INR; Grade 3 | 1 | 0 | 0 | 0 |
| INR; Grade 4 | 0 | 1 | 0 | 0 |
| Platelet count; Grade 1 | 4 | 0 | 4 | 1 |
| Platelet count; Grade 2 | 0 | 0 | 1 | 0 |
| Platelet count; Grade 3 | 0 | 0 | 1 | 0 |
| Platelet count; Grade 4 | 0 | 0 | 1 | 0 |
| PT; Grade 1 | 1 | 3 | 0 | 3 |
| PT; Grade 2 | 0 | 0 | 0 | 1 |
| PT; Grade 3 | 0 | 1 | 1 | 0 |
| PT; Grade 4 | 0 | 1 | 0 | 0 |
| Total neutrophils; Grade 1 | 7 | 9 | 10 | 2 |
| Total neutrophils; Grade 2 | 5 | 2 | 3 | 3 |
| Total neutrophils; Grade 3 | 1 | 0 | 1 | 1 |
| Total neutrophils; Grade 4 | 1 | 1 | 3 | 1 |
| WBC count; Grade 1 | 2 | 5 | 2 | 3 |
| WBC count; Grade 2 | 1 | 1 | 1 | 0 |
| WBC count; Grade 3 | 0 | 0 | 1 | 0 |
| WBC count; Grade 4 | 0 | 0 | 0 | 0 |
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Safety Population comprised of all randomized participants who were exposed to investigational products with the exception of any participants with documented evidence of not having consumed any amount of investigational product.
| Participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Any AE | 57 | 57 | 60 | 60 |
| Any SAE | 13 | 12 | 11 | 4 |
Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, cholesterol, CK, creatinine, glucose, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
| Participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| ALT; Grade 1 | 9 | 12 | 19 | 8 |
| ALT; Grade 2 | 6 | 6 | 5 | 4 |
| ALT; Grade 3 | 0 | 1 | 0 | 0 |
| ALT; Grade 4 | 1 | 1 | 2 | 1 |
| Albumin; Grade 1 | 0 | 1 | 0 | 0 |
| Albumin; Grade 2 | 0 | 0 | 0 | 0 |
| Albumin; Grade 3 | 0 | 0 | 0 | 0 |
| Albumin; Grade 4 | 0 | 0 | 0 | 0 |
| ALP; Grade 1 | 2 | 1 | 4 | 5 |
| ALP; Grade 2 | 0 | 1 | 0 | 0 |
| ALP; Grade 3 | 0 | 0 | 0 | 0 |
| ALP; Grade 4 | 0 | 0 | 0 | 0 |
| AST; Grade 1 | 7 | 13 | 15 | 7 |
| AST; Grade 2 | 6 | 8 | 5 | 2 |
| AST; Grade 3 | 2 | 0 | 4 | 3 |
| AST; Grade 4 | 2 | 1 | 0 | 2 |
| CO2/bicarbonate; Grade 1 | 6 | 14 | 9 | 8 |
| CO2/bicarbonate; Grade 2 | 1 | 0 | 0 | 1 |
| CO2/bicarbonate; Grade 3 | 0 | 0 | 0 | 0 |
| CO2/bicarbonate; Grade 4 | 0 | 0 | 0 | 0 |
| Cholesterol; Grade 1 | 17 | 17 | 19 | 9 |
| Cholesterol; Grade 2 | 7 | 12 | 15 | 10 |
| Cholesterol; Grade 3 | 3 | 0 | 3 | 6 |
| Cholesterol; Grade 4 | 0 | 0 | 0 | 0 |
| CK; Grade 1 | 9 | 10 | 12 | 5 |
| CK; Grade 2 | 2 | 4 | 4 | 0 |
| CK; Grade 3 | 3 | 2 | 4 | 4 |
| CK; Grade 4 | 7 | 6 | 5 | 5 |
| Creatinine; Grade 1 | 1 | 1 | 2 | 1 |
| Creatinine; Grade 2 | 1 | 0 | 0 | 1 |
| Creatinine; Grade 3 | 0 | 0 | 0 | 0 |
| Creatinine; Grade 4 | 0 | 0 | 0 | 0 |
| Glucose; Grade 1 | 19 | 18 | 21 | 12 |
| Glucose; Grade 2 | 14 | 10 | 11 | 6 |
| Glucose; Grade 3 | 0 | 0 | 2 | 0 |
| Glucose; Grade 4 | 0 | 0 | 0 | 1 |
| LDL cholesterol; Grade 1 | 14 | 17 | 13 | 8 |
| LDL cholesterol; Grade 2 | 7 | 11 | 14 | 7 |
| LDL cholesterol; Grade 3 | 4 | 2 | 7 | 4 |
| LDL cholesterol; Grade 4 | 0 | 0 | 0 | 0 |
| Lipase; Grade 1 | 11 | 9 | 9 | 10 |
| Lipase; Grade 2 | 9 | 8 | 11 | 7 |
| Lipase; Grade 3 | 5 | 2 | 6 | 1 |
| Lipase; Grade 4 | 2 | 0 | 2 | 0 |
| Inorganic phosphorus; Grade 1 | 5 | 3 | 10 | 8 |
| Inorganic phosphorus; Grade 2 | 11 | 11 | 6 | 9 |
| Inorganic phosphorus; Grade 3 | 2 | 1 | 5 | 2 |
| Inorganic phosphorus; Grade 4 | 0 | 0 | 0 | 0 |
| Potassium; Grade 1 | 14 | 7 | 8 | 4 |
| Potassium; Grade 2 | 0 | 0 | 0 | 1 |
| Potassium; Grade 3 | 0 | 0 | 0 | 0 |
| Potassium; Grade 4 | 0 | 0 | 0 | 0 |
| Sodium; Grade 1 | 14 | 12 | 16 | 11 |
| Sodium; Grade 2 | 2 | 1 | 0 | 1 |
| Sodium; Grade 3 | 0 | 0 | 0 | 0 |
| Sodium; Grade 4 | 0 | 0 | 0 | 0 |
| Total bilirubin; Grade 1 | 7 | 1 | 8 | 0 |
| Total bilirubin; Grade 2 | 2 | 3 | 4 | 0 |
| Total bilirubin; Grade 3 | 0 | 1 | 0 | 0 |
| Total bilirubin; Grade 4 | 0 | 0 | 0 | 0 |
| Triglycerides; Grade 1 | 0 | 0 | 0 | 0 |
| Triglycerides; Grade 2 | 1 | 4 | 3 | 1 |
| Triglycerides; Grade 3 | 1 | 0 | 3 | 1 |
| Triglycerides; Grade 4 | 0 | 0 | 1 | 1 |
Blood samples were collected for the analysis of following hematology parameters: APTT, hemoglobin, INR, platelet count, PT, total neutrophils and WBC count. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
| Participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| APTT; Grade 1 | 5 | 5 | 5 | 5 |
| APTT; Grade 2 | 0 | 1 | 0 | 0 |
| APTT; Grade 3 | 0 | 0 | 0 | 0 |
| APTT; Grade 4 | 1 | 1 | 1 | 1 |
| Hemoglobin; Grade 1 | 0 | 0 | 0 | 0 |
| Hemoglobin; Grade 2 | 1 | 0 | 0 | 0 |
| Hemoglobin; Grade 3 | 0 | 0 | 0 | 0 |
| Hemoglobin; Grade 4 | 0 | 0 | 0 | 0 |
| INR; Grade 1 | 2 | 4 | 0 | 3 |
| INR; Grade 2 | 0 | 1 | 1 | 1 |
| INR; Grade 3 | 1 | 0 | 0 | 0 |
| INR; Grade 4 | 0 | 1 | 0 | 0 |
| Platelet count; Grade 1 | 4 | 0 | 4 | 1 |
| Platelet count; Grade 2 | 0 | 0 | 1 | 0 |
| Platelet count; Grade 3 | 0 | 0 | 1 | 0 |
| Platelet count; Grade 4 | 0 | 0 | 1 | 0 |
| PT; Grade 1 | 1 | 3 | 0 | 3 |
| PT; Grade 2 | 0 | 0 | 0 | 1 |
| PT; Grade 3 | 0 | 1 | 1 | 0 |
| PT; Grade 4 | 0 | 1 | 0 | 0 |
| Total neutrophils; Grade 1 | 7 | 9 | 10 | 2 |
| Total neutrophils; Grade 2 | 5 | 2 | 3 | 3 |
| Total neutrophils; Grade 3 | 1 | 0 | 1 | 1 |
| Total neutrophils; Grade 4 | 1 | 1 | 3 | 1 |
| WBC count; Grade 1 | 2 | 5 | 2 | 3 |
| WBC count; Grade 2 | 1 | 1 | 1 | 0 |
| WBC count; Grade 3 | 0 | 0 | 1 | 0 |
| WBC count; Grade 4 | 0 | 0 | 0 | 0 |
Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed.
| International Units per Liter | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| ALT; Baseline; n=60, 60, 61, 62 | 23.9 ± 12.38 | 28.1 ± 17.65 | 28.5 ± 20.60 | 30.5 ± 29.21 |
| ALT; Week 2; n=58, 56, 58, 58 | 24.0 ± 13.29 | 26.3 ± 17.81 | 27.2 ± 14.49 | 30.0 ± 26.73 |
| ALT; Week 4; n=58, 57, 59, 57 | 23.1 ± 14.31 | 25.6 ± 17.29 | 30.3 ± 24.25 | 31.4 ± 27.43 |
| ALT; Week 8; n=58, 55, 57, 54 | 25.4 ± 16.06 | 29.3 ± 23.15 | 35.9 ± 63.11 | 25.0 ± 13.21 |
| ALT; Week 12; n=58, 53, 57, 51 | 25.0 ± 15.37 | 31.4 ± 28.65 | 26.6 ± 16.27 | 25.7 ± 17.44 |
| ALT; Week 16; n=57, 54, 57, 52 | 26.0 ± 25.88 | 28.5 ± 27.79 | 26.9 ± 18.68 | 30.4 ± 22.55 |
| ALT; Week 20; n=56, 54, 55, 49 | 22.3 ± 11.62 | 24.9 ± 15.72 | 30.3 ± 24.34 | 27.0 ± 15.71 |
| ALT; Week 24; n=56, 53, 56, 47 | 20.9 ± 9.86 | 27.5 ± 23.90 | 28.6 ± 19.62 | 25.7 ± 13.31 |
| ALT; Week 26; n=48, 50, 53, 45 | 24.2 ± 16.54 | 26.6 ± 26.63 | 23.5 ± 10.77 | 28.3 ± 25.23 |
| ALT; Week 28; n=51, 52, 52, 45 | 20.4 ± 11.47 | 26.5 ± 26.66 | 24.8 ± 14.94 | 24.2 ± 13.67 |
| ALT; Week 32; n=52, 53, 55, 45 | 19.5 ± 9.83 | 26.9 ± 27.66 | 23.2 ± 14.67 | 23.1 ± 10.19 |
| ALT; Week 36; n=52, 52, 55, 45 | 23.4 ± 26.79 | 24.7 ± 17.44 | 24.2 ± 15.60 | 23.5 ± 10.53 |
| ALT; Week 40; n=52, 53, 55, 44 | 22.7 ± 18.13 | 24.6 ± 15.43 | 25.8 ± 23.50 | 23.4 ± 10.92 |
| ALT; Week 48; n=51, 53, 54, 44 | 18.4 ± 8.32 | 24.8 ± 15.91 | 24.8 ± 19.60 | 22.6 ± 10.92 |
| ALT; Week 60; n=48, 47, 53, 44 | 21.4 ± 17.70 | 25.9 ± 16.69 | 28.1 ± 26.70 | 24.9 ± 13.59 |
| ALT; Week 72; n=47, 47, 52, 42 | 19.9 ± 9.98 | 30.7 ± 28.68 | 26.3 ± 20.29 | 22.7 ± 9.62 |
| ALT; Week 84; n=46, 48, 52, 42 | 20.1 ± 11.56 | 29.9 ± 20.77 | 25.3 ± 19.53 | 27.1 ± 32.55 |
| ALT; Week 96; n=45, 48, 52, 40 | 22.0 ± 18.20 | 48.7 ± 153.96 | 25.5 ± 21.23 | 24.3 ± 22.84 |
| AST; Baseline; n=60, 60, 61, 62 | 25.0 ± 7.36 | 27.5 ± 11.15 | 28.1 ± 12.01 | 31.5 ± 28.43 |
| AST; Week 2; n=58, 56, 58, 58 | 25.6 ± 8.36 | 26.6 ± 11.38 | 26.8 ± 8.60 | 32.8 ± 51.17 |
| AST; Week 4; n=58, 57, 59, 57 | 24.0 ± 7.95 | 25.0 ± 11.37 | 28.3 ± 16.29 | 29.0 ± 15.61 |
| AST; Week 8; n=58, 55, 57, 54 | 28.7 ± 31.34 | 29.5 ± 23.47 | 32.8 ± 37.43 | 24.4 ± 5.73 |
| AST; Week 12; n=58, 53, 57, 51 | 26.3 ± 13.40 | 29.0 ± 24.56 | 25.5 ± 8.05 | 24.4 ± 9.49 |
| AST; Week 16; n=57, 54, 57, 52 | 24.2 ± 12.70 | 29.2 ± 24.00 | 26.5 ± 9.42 | 36.7 ± 71.83 |
| AST; Week 20; n=56, 54, 55, 49 | 26.0 ± 20.71 | 24.2 ± 10.38 | 31.7 ± 26.31 | 28.7 ± 28.75 |
| AST; Week 24; n=56, 53, 56, 47 | 23.3 ± 8.93 | 27.2 ± 17.43 | 28.6 ± 14.12 | 26.1 ± 9.61 |
| AST; Week 26; n=48, 50, 53, 45 | 28.4 ± 28.28 | 26.9 ± 18.86 | 24.5 ± 6.64 | 25.8 ± 12.21 |
| AST; Week 28; n=51, 52, 52, 45 | 22.6 ± 8.77 | 26.7 ± 16.58 | 25.5 ± 11.24 | 23.7 ± 7.89 |
| AST; Week 32; n=52, 53, 55, 45 | 21.9 ± 7.74 | 26.5 ± 19.14 | 25.6 ± 9.19 | 25.4 ± 12.33 |
| AST; Week 36; n=52, 52, 55, 45 | 29.2 ± 39.15 | 25.4 ± 12.50 | 26.4 ± 11.38 | 26.3 ± 13.66 |
| AST; Week 40; n=52, 53, 55, 44 | 24.7 ± 14.04 | 24.5 ± 10.35 | 26.5 ± 14.21 | 23.0 ± 6.17 |
| AST; Week 48; n=51, 53, 54, 44 | 21.4 ± 8.02 | 24.3 ± 12.32 | 24.2 ± 9.26 | 23.7 ± 8.45 |
| AST; Week 60; n=48, 47, 53, 44 | 23.4 ± 10.41 | 25.3 ± 12.77 | 30.4 ± 21.00 | 24.9 ± 8.31 |
| AST; Week 72; n=47, 47, 52, 42 | 21.8 ± 7.67 | 31.0 ± 22.80 | 26.4 ± 10.52 | 22.9 ± 6.28 |
| AST; Week 84; n=46, 48, 52, 42 | 22.3 ± 8.10 | 29.2 ± 16.93 | 25.2 ± 9.11 | 29.9 ± 37.33 |
| AST; Week 96; n=45, 48, 52, 40 | 23.6 ± 22.38 | 47.7 ± 150.51 | 25.9 ± 12.90 | 27.7 ± 35.71 |
| CK; Baseline; n=60, 60, 61, 62 | 197.3 ± 178.83 | 295.9 ± 604.02 | 181.2 ± 217.99 | 349.8 ± 1521.09 |
| CK; Week 2; n=58, 56, 58, 58 | 237.9 ± 271.07 | 276.1 ± 468.74 | 184.8 ± 143.83 | 512.1 ± 2788.37 |
| CK; Week 4; n=58, 57, 59, 57 | 196.7 ± 159.74 | 221.8 ± 426.95 | 180.5 ± 174.80 | 236.2 ± 563.36 |
| CK; Week 8; n=58, 55, 57, 54 | 413.3 ± 1523.18 | 427.2 ± 1518.27 | 451.7 ± 1788.60 | 152.9 ± 94.19 |
| CK; Week 12; n=58, 53, 57, 51 | 316.1 ± 570.21 | 314.7 ± 1116.09 | 211.8 ± 174.07 | 161.2 ± 163.26 |
| CK; Week 16; n=57, 54, 57, 52 | 195.1 ± 180.51 | 427.3 ± 1339.99 | 213.3 ± 190.94 | 646.5 ± 3471.23 |
| CK; Week 20; n=56, 54, 55, 49 | 342.7 ± 953.66 | 202.1 ± 309.41 | 485.3 ± 1835.11 | 528.2 ± 2643.29 |
| CK; Week 24; n=56, 53, 56, 47 | 226.0 ± 230.13 | 306.3 ± 690.18 | 243.0 ± 228.95 | 247.4 ± 498.72 |
| CK; Week 26; n=48, 50, 53, 45 | 344.1 ± 606.10 | 267.7 ± 516.53 | 242.5 ± 275.72 | 163.5 ± 156.79 |
| CK; Week 28; n=51, 52, 52, 45 | 213.4 ± 182.12 | 276.8 ± 581.44 | 290.4 ± 457.59 | 154.7 ± 168.77 |
| CK; Week 32; n=52, 53, 55, 45 | 205.6 ± 171.74 | 248.8 ± 525.79 | 311.3 ± 437.31 | 254.7 ± 778.33 |
| CK; Week 36; n=52, 52, 55, 45 | 528.4 ± 1984.77 | 242.9 ± 353.65 | 255.2 ± 275.74 | 303.1 ± 615.91 |
| CK; Week 40; n=52, 53, 55, 44 | 259.5 ± 381.33 | 225.4 ± 342.50 | 292.6 ± 360.32 | 150.2 ± 96.11 |
| CK; Week 48; n=51, 53, 54, 44 | 203.5 ± 136.48 | 219.3 ± 527.75 | 219.8 ± 195.62 | 146.3 ± 88.07 |
| CK; Week 60; n=48, 47, 53, 44 | 315.7 ± 730.27 | 215.5 ± 340.37 | 399.6 ± 923.74 | 168.0 ± 154.36 |
| CK; Week 72; n=47, 47, 52, 42 | 182.5 ± 148.31 | 354.0 ± 911.76 | 247.7 ± 348.72 | 120.5 ± 59.89 |
| CK; Week 84; n=46, 48, 52, 42 | 204.3 ± 160.30 | 329.2 ± 724.97 | 195.0 ± 164.14 | 258.6 ± 650.38 |
| CK; Week 96; n=45, 48, 52, 40 | 542.7 ± 2451.57 | 272.8 ± 589.15 | 199.7 ± 194.46 | 281.1 ± 903.71 |
Blood samples were collected for the analysis of creatinine and total bilirubin (T. bilirubin). Baseline value is the last pre-treatment value observed.
| Micromoles per liter | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Creatinine; Baseline; n=60, 60, 61, 62 | 80.4 ± 13.69 | 80.5 ± 13.55 | 79.9 ± 14.11 | 83.1 ± 13.41 |
| Creatinine; Week 2; n=58, 56, 58, 58 | 83.8 ± 14.33 | 83.3 ± 14.10 | 84.6 ± 15.27 | 83.8 ± 15.29 |
| Creatinine; Week 4; n=58, 57, 59, 57 | 82.9 ± 15.45 | 83.0 ± 14.55 | 84.2 ± 14.28 | 83.1 ± 14.22 |
| Creatinine; Week 8; n=58, 55, 57, 54 | 82.9 ± 13.79 | 82.2 ± 13.03 | 83.5 ± 14.41 | 82.4 ± 13.94 |
| Creatinine; Week 12; n=58, 53, 57, 51 | 83.8 ± 13.33 | 82.7 ± 14.96 | 84.1 ± 14.64 | 81.1 ± 12.83 |
| Creatinine; Week 16; n=57, 54, 57, 52 | 83.4 ± 17.07 | 82.3 ± 14.56 | 82.4 ± 14.16 | 79.6 ± 11.83 |
| Creatinine; Week 20; n=56, 54, 55, 49 | 83.2 ± 12.95 | 82.0 ± 14.42 | 86.1 ± 14.34 | 79.5 ± 11.72 |
| Creatinine; Week 24; n=56, 53, 56, 47 | 83.2 ± 13.07 | 83.3 ± 15.56 | 85.2 ± 13.93 | 80.0 ± 20.74 |
| Creatinine; Week 26; n=48, 50, 53, 45 | 83.4 ± 13.45 | 82.6 ± 14.15 | 87.0 ± 13.82 | 78.6 ± 9.61 |
| Creatinine; Week 28; n=51, 52, 52, 45 | 83.0 ± 13.32 | 83.8 ± 14.84 | 85.6 ± 13.96 | 78.5 ± 10.34 |
| Creatinine; Week 32; n=52, 53, 55, 45 | 83.8 ± 14.11 | 82.6 ± 13.48 | 85.7 ± 14.34 | 78.1 ± 9.90 |
| Creatinine; Week 36; n=52, 52, 55, 45 | 83.5 ± 12.68 | 84.6 ± 13.22 | 86.7 ± 16.21 | 78.4 ± 10.87 |
| Creatinine; Week 40; n=52, 53, 55, 44 | 83.3 ± 12.60 | 83.2 ± 13.04 | 85.4 ± 14.38 | 79.2 ± 15.99 |
| Creatinine; Week 48; n=51, 53, 54, 44 | 83.4 ± 13.48 | 83.1 ± 14.55 | 85.0 ± 14.54 | 79.0 ± 12.52 |
| Creatinine; Week 60; n=48, 47, 53, 44 | 83.9 ± 13.85 | 83.0 ± 14.31 | 85.2 ± 14.57 | 77.9 ± 11.13 |
| Creatinine; Week 72; n=47, 47, 52, 42 | 84.5 ± 12.46 | 86.1 ± 14.95 | 87.3 ± 14.95 | 77.7 ± 11.44 |
| Creatinine; Week 84; n=46, 48, 52, 42 | 85.0 ± 15.06 | 84.8 ± 17.41 | 87.3 ± 13.15 | 79.7 ± 11.20 |
| Creatinine; Week 96; n=45, 48, 52, 40 | 82.0 ± 11.46 | 86.4 ± 17.24 | 88.5 ± 14.75 | 81.0 ± 10.10 |
| T. Bilirubin; Baseline; n=60, 60, 61, 62 | 9.2 ± 4.65 | 9.4 ± 4.59 | 10.5 ± 5.48 | 9.7 ± 4.42 |
| T. Bilirubin; Week 2; n=58, 56, 58, 58 | 9.2 ± 4.48 | 9.1 ± 4.50 | 10.0 ± 5.92 | 6.8 ± 1.71 |
| T. Bilirubin; Week 4; n=58, 57, 59, 57 | 9.4 ± 4.40 | 9.3 ± 4.47 | 9.8 ± 6.05 | 6.4 ± 1.61 |
| T. Bilirubin; Week 8; n=58, 55, 57, 54 | 9.3 ± 4.50 | 9.0 ± 3.33 | 10.1 ± 5.55 | 6.3 ± 1.46 |
| T. Bilirubin; Week 12; n=58, 53, 57, 51 | 9.5 ± 5.16 | 8.9 ± 3.79 | 10.2 ± 5.47 | 7.0 ± 2.57 |
| T. Bilirubin; Week 16; n=57, 54, 57, 52 | 9.6 ± 5.04 | 8.5 ± 3.90 | 10.4 ± 4.88 | 7.0 ± 2.61 |
| T. Bilirubin; Week 20; n=56, 54, 55, 49 | 9.0 ± 4.09 | 9.0 ± 4.91 | 10.4 ± 5.49 | 6.8 ± 1.67 |
| T. Bilirubin; Week 24; n=56, 53, 56, 47 | 9.6 ± 5.18 | 9.8 ± 5.09 | 10.0 ± 4.52 | 6.6 ± 1.60 |
| T. Bilirubin; Week 26; n=48, 50, 53, 45 | 10.6 ± 4.97 | 9.9 ± 5.83 | 12.0 ± 5.11 | 6.8 ± 2.19 |
| T. Bilirubin; Week 28; n=51, 52, 52, 45 | 10.3 ± 4.87 | 10.2 ± 5.90 | 11.4 ± 4.77 | 6.4 ± 1.51 |
| T. Bilirubin; Week 32; n=52, 53, 55, 45 | 9.8 ± 4.91 | 9.8 ± 4.80 | 11.7 ± 6.70 | 6.6 ± 1.74 |
| T. Bilirubin; Week 36; n=52, 52, 55, 45 | 10.3 ± 5.25 | 10.1 ± 5.47 | 12.2 ± 6.08 | 6.5 ± 1.71 |
| T. Bilirubin; Week 40; n=52, 53, 55, 44 | 10.8 ± 5.81 | 11.2 ± 7.04 | 12.3 ± 6.67 | 6.3 ± 1.53 |
| T. Bilirubin; Week 48; n=51, 53, 54, 44 | 10.0 ± 4.96 | 9.6 ± 3.86 | 10.4 ± 4.91 | 6.6 ± 1.65 |
| T. Bilirubin; Week 60; n=48, 47, 53, 44 | 11.2 ± 4.28 | 9.8 ± 3.75 | 11.6 ± 6.28 | 7.0 ± 2.13 |
| T. Bilirubin; Week 72; n=47, 47, 52, 42 | 10.8 ± 6.63 | 10.0 ± 4.89 | 11.4 ± 5.87 | 6.5 ± 1.40 |
| T. Bilirubin; Week 84; n=46, 48, 52, 42 | 11.7 ± 6.77 | 9.9 ± 4.35 | 12.0 ± 5.64 | 6.6 ± 2.27 |
| T. Bilirubin; Week 96; n=45, 48, 52, 40 | 10.3 ± 5.29 | 9.9 ± 4.58 | 12.5 ± 5.61 | 6.8 ± 1.80 |
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed.
| Milliliters per minute | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Baseline; n=60, 60, 61, 62 | 131.0 ± 28.18 | 135.2 ± 41.33 | 128.3 ± 33.51 | 125.6 ± 35.30 |
| Week 2; n=1, 1, 0, 3 | 96.0 ± NA | 106.0 ± NA | — | 99.0 ± 31.00 |
| Week 4; n=58, 57, 59, 57 | 129.3 ± 31.29 | 132.5 ± 42.28 | 122.4 ± 33.00 | 127.0 ± 35.64 |
| Week 8; n=2, 1, 1, 1 | 125.0 ± 35.36 | 124.0 ± NA | 143.0 ± NA | 101.0 ± NA |
| Week 16; n=55, 53, 56, 49 | 132.4 ± 50.97 | 139.4 ± 42.30 | 123.9 ± 31.85 | 132.3 ± 39.97 |
| Week 20; n=2, 0, 0, 1 | 137.0 ± 11.31 | — | — | 122.0 ± NA |
| Week 24; n=52, 53, 55, 46 | 127.9 ± 30.90 | 132.8 ± 39.93 | 120.7 ± 27.41 | 135.1 ± 38.98 |
| Week 26; n=0, 1, 0, 0 | — | 147.0 ± NA | — | — |
| Week 40; n=0, 1, 0, 0 | — | 180.0 ± NA | — | — |
| Week 48; n=51, 50, 54, 44 | 127.0 ± 30.01 | 139.2 ± 42.07 | 122.3 ± 29.21 | 131.0 ± 44.41 |
| Week 60; n=0, 0, 0, 1 | — | — | — | 144.0 ± NA |
| Week 96; n=45, 48, 52, 40 | 130.8 ± 40.80 | 137.7 ± 45.07 | 116.6 ± 27.05 | 134.8 ± 43.35 |
Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed.
| Grams per liter | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Baseline; n=60, 60, 61, 62 | 141.9 ± 12.46 | 143.2 ± 10.66 | 146.6 ± 13.41 | 145.4 ± 12.39 |
| Week 2; n=57, 56, 59, 59 | 142.0 ± 13.84 | 142.8 ± 11.68 | 145.9 ± 12.05 | 146.4 ± 13.49 |
| Week 4; n=57, 57, 59, 57 | 141.9 ± 13.39 | 143.5 ± 11.69 | 147.3 ± 12.13 | 146.6 ± 13.06 |
| Week 8; n=58, 56, 56, 55 | 144.9 ± 13.10 | 147.7 ± 11.88 | 148.6 ± 12.10 | 148.1 ± 12.32 |
| Week 12; n=58, 53, 57, 51 | 144.3 ± 12.19 | 147.4 ± 10.60 | 149.1 ± 11.25 | 149.2 ± 13.14 |
| Week 16; n=57, 54, 57, 52 | 143.5 ± 11.77 | 146.5 ± 10.71 | 148.7 ± 11.08 | 147.6 ± 12.05 |
| Week 20; n=56, 54, 55, 49 | 144.3 ± 13.33 | 146.9 ± 11.23 | 149.8 ± 11.11 | 147.2 ± 12.18 |
| Week 24; n=56, 53, 56, 47 | 144.8 ± 12.66 | 147.8 ± 10.69 | 150.4 ± 11.65 | 148.5 ± 11.31 |
| Week 26; n=48, 50, 53, 45 | 144.4 ± 13.30 | 145.8 ± 11.63 | 149.8 ± 11.47 | 148.2 ± 12.32 |
| Week 28; n=50, 52, 52, 45 | 143.7 ± 13.20 | 146.8 ± 10.89 | 149.3 ± 10.15 | 145.9 ± 13.17 |
| Week 32; n=51, 53, 55, 45 | 144.6 ± 9.53 | 146.1 ± 10.44 | 150.5 ± 11.19 | 145.9 ± 11.41 |
| Week 36; n=52, 53, 55, 44 | 142.3 ± 11.07 | 145.9 ± 11.24 | 149.8 ± 11.26 | 145.0 ± 10.73 |
| Week 40; n=51, 53, 55, 45 | 142.2 ± 11.06 | 145.2 ± 11.03 | 149.2 ± 11.71 | 145.1 ± 9.98 |
| Week 48; n=51, 53, 54, 44 | 142.9 ± 9.15 | 145.7 ± 10.59 | 146.5 ± 12.48 | 145.4 ± 12.24 |
| Week 60; n=48, 47, 52, 44 | 144.5 ± 9.91 | 148.3 ± 10.96 | 149.8 ± 10.82 | 147.6 ± 12.73 |
| Week 72; n=47, 48, 52, 42 | 143.9 ± 10.24 | 148.1 ± 10.15 | 149.6 ± 11.46 | 147.7 ± 11.22 |
| Week 84; n=46, 48, 51, 42 | 145.6 ± 11.00 | 147.7 ± 10.04 | 150.3 ± 10.38 | 147.0 ± 11.77 |
| Week 96; n=46, 46, 52, 41 | 144.9 ± 12.41 | 147.1 ± 11.06 | 150.8 ± 10.37 | 147.0 ± 11.03 |
Blood samples were collected for the analysis of platelet count, total neutrophils (T. neutrophils) and WBC count. Baseline value is the last pre-treatment value observed.
| Giga cells per liter | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| T. neutrophils; Baseline; n=60, 60, 61, 62 | 2.643 ± 1.1237 | 2.891 ± 1.4383 | 2.487 ± 1.0240 | 2.441 ± 1.1548 |
| T. neutrophils; Week 2; n=57, 56, 59, 59 | 2.723 ± 1.1402 | 2.776 ± 1.0729 | 2.598 ± 1.1295 | 3.207 ± 1.6307 |
| T. neutrophils; Week 4; n=57, 57, 59, 57 | 2.685 ± 1.2477 | 2.771 ± 1.2587 | 2.649 ± 1.0692 | 2.848 ± 1.8642 |
| T. neutrophils; Week 8; n=58, 56, 56, 55 | 2.899 ± 1.2111 | 2.802 ± 1.1296 | 2.738 ± 1.1533 | 2.746 ± 0.9969 |
| T. neutrophils; Week 12; n=58, 53, 57, 51 | 2.812 ± 1.1377 | 2.933 ± 1.5977 | 2.822 ± 1.3294 | 2.979 ± 1.7673 |
| T. neutrophils; Week 16; n=57, 54, 57, 52 | 3.078 ± 1.5948 | 2.716 ± 1.1022 | 2.665 ± 1.0287 | 2.858 ± 1.1909 |
| T. neutrophils; Week 20; n=56, 54, 55, 49 | 2.958 ± 1.2918 | 2.904 ± 1.1794 | 2.989 ± 1.6589 | 3.187 ± 1.6424 |
| T. neutrophils; Week 24; n=56, 53, 56, 47 | 3.151 ± 1.2378 | 2.996 ± 1.5425 | 2.884 ± 1.0047 | 3.142 ± 1.6483 |
| T. neutrophils; Week 26; n=48, 50, 53, 45 | 2.885 ± 1.0874 | 2.958 ± 1.2097 | 2.830 ± 1.0354 | 2.886 ± 1.3159 |
| T. neutrophils; Week 28; n=50, 52, 52, 45 | 3.183 ± 1.0674 | 3.005 ± 1.0029 | 2.989 ± 1.4078 | 2.916 ± 1.0731 |
| T. neutrophils; Week 32; n=51, 53, 55, 45 | 2.797 ± 0.9490 | 3.036 ± 1.1931 | 3.167 ± 1.3992 | 3.174 ± 1.7150 |
| T. neutrophils; Week 36; n=52, 53, 55, 44 | 3.162 ± 1.1538 | 2.916 ± 1.2331 | 3.010 ± 1.0698 | 2.914 ± 1.2530 |
| T. neutrophils; Week 40; n=51, 53, 55, 45 | 3.155 ± 1.3417 | 3.065 ± 1.2945 | 3.050 ± 1.0745 | 3.187 ± 1.6006 |
| T. neutrophils; Week 48; n=51, 53, 54, 44 | 3.138 ± 1.3751 | 3.132 ± 1.1976 | 3.004 ± 1.1720 | 3.134 ± 1.6646 |
| T. neutrophils; Week 60; n=48, 47, 52, 44 | 3.164 ± 1.3804 | 3.333 ± 1.5642 | 3.200 ± 1.2159 | 3.269 ± 1.3866 |
| T. neutrophils; Week 72; n=47, 48, 52, 42 | 3.197 ± 1.2931 | 3.131 ± 1.2337 | 3.163 ± 1.0874 | 3.361 ± 1.8047 |
| T. neutrophils; Week 84; n=46, 48, 51, 42 | 3.245 ± 1.4593 | 3.385 ± 1.3591 | 3.512 ± 1.3176 | 3.259 ± 1.6532 |
| T. neutrophils; Week 96; n=46, 46, 52, 41 | 3.466 ± 1.1229 | 3.540 ± 1.7870 | 3.494 ± 1.2790 | 3.297 ± 1.4509 |
| Platelet count; Baseline; n=60, 60, 61, 62 | 212.5 ± 53.22 | 202.3 ± 51.74 | 190.0 ± 55.71 | 200.1 ± 52.36 |
| Platelet count; Week 2; n=57, 56, 59, 59 | 225.0 ± 54.84 | 222.0 ± 48.82 | 204.8 ± 50.51 | 216.2 ± 52.60 |
| Platelet count; Week 4; n=57, 57, 59, 57 | 225.2 ± 52.94 | 222.4 ± 52.61 | 204.6 ± 57.51 | 216.0 ± 55.41 |
| Platelet count; Week 8; n=58, 56, 56, 55 | 224.5 ± 50.94 | 228.4 ± 57.01 | 211.5 ± 56.80 | 209.8 ± 48.62 |
| Platelet count; Week 12; n=58, 53, 57, 51 | 227.2 ± 49.64 | 216.4 ± 52.46 | 209.2 ± 51.62 | 213.7 ± 50.65 |
| Platelet count; Week 16; n=57, 54, 57, 52 | 230.0 ± 59.33 | 212.4 ± 54.22 | 209.5 ± 50.32 | 211.4 ± 50.56 |
| Platelet count; Week 20; n=56, 54, 55, 49 | 231.3 ± 55.14 | 215.5 ± 47.03 | 205.4 ± 48.40 | 214.9 ± 51.41 |
| Platelet count; Week 24; n=56, 53, 56, 47 | 226.1 ± 52.17 | 219.7 ± 50.75 | 210.9 ± 56.34 | 220.9 ± 67.67 |
| Platelet count; Week 26; n=48, 50, 53, 45 | 224.9 ± 56.06 | 215.5 ± 53.10 | 199.4 ± 60.65 | 214.4 ± 53.90 |
| Platelet count; Week 28; n=50, 52, 52, 45 | 223.3 ± 50.28 | 217.0 ± 56.54 | 209.8 ± 56.65 | 215.4 ± 57.81 |
| Platelet count; Week 32; n=51, 52, 55, 45 | 220.5 ± 55.37 | 214.0 ± 46.66 | 207.8 ± 53.33 | 212.6 ± 52.27 |
| Platelet count; Week 36; n=52, 53, 55, 44 | 220.0 ± 47.58 | 212.1 ± 51.61 | 204.2 ± 54.34 | 209.8 ± 52.54 |
| Platelet count; Week 40; n=51, 53, 54, 45 | 224.9 ± 52.93 | 210.1 ± 55.87 | 199.3 ± 52.37 | 217.7 ± 54.40 |
| Platelet count; Week 48; n=51, 52, 53, 44 | 225.6 ± 60.05 | 221.2 ± 56.12 | 209.9 ± 56.81 | 220.3 ± 52.52 |
| Platelet count; Week 60; n=48, 47, 51, 44 | 232.5 ± 57.00 | 219.8 ± 55.01 | 212.2 ± 53.68 | 230.5 ± 56.39 |
| Platelet count; Week 72; n=47, 48, 52, 42 | 234.0 ± 52.53 | 224.4 ± 50.06 | 212.2 ± 52.59 | 225.9 ± 52.62 |
| Platelet count; Week 84; n=46, 48, 51, 42 | 224.8 ± 52.36 | 218.8 ± 49.15 | 210.1 ± 51.72 | 216.5 ± 53.09 |
| Platelet count; Week 96; n=46, 45, 51, 41 | 237.1 ± 58.94 | 221.8 ± 57.95 | 210.6 ± 57.34 | 214.0 ± 51.10 |
| WBC count; Baseline; n=60, 60, 61, 62 | 5.06 ± 1.552 | 5.19 ± 1.632 | 4.72 ± 1.332 | 4.70 ± 1.388 |
| WBC count; Week 2; n=57, 56, 59, 59 | 5.32 ± 1.602 | 5.30 ± 1.448 | 5.02 ± 1.355 | 5.45 ± 1.856 |
| WBC count; Week 4; n=57, 57, 59, 57 | 5.24 ± 1.802 | 5.17 ± 1.604 | 5.02 ± 1.342 | 5.02 ± 1.993 |
| WBC count; Week 8; n=58, 56, 56, 55 | 5.44 ± 1.751 | 5.30 ± 1.556 | 5.04 ± 1.230 | 5.02 ± 1.195 |
| WBC count; Week 12; n=58, 53, 57, 51 | 5.41 ± 1.560 | 5.50 ± 1.794 | 5.34 ± 1.524 | 5.27 ± 1.899 |
| WBC count; Week 16; n=57, 54, 57, 52 | 5.56 ± 1.895 | 5.20 ± 1.337 | 4.97 ± 1.108 | 5.13 ± 1.480 |
| WBC count; Week 20; n=56, 54, 55, 49 | 5.46 ± 1.486 | 5.41 ± 1.354 | 5.39 ± 1.877 | 5.50 ± 1.763 |
| WBC count; Week 24; n=56, 53, 56, 47 | 5.57 ± 1.558 | 5.53 ± 1.993 | 5.28 ± 1.367 | 5.34 ± 1.854 |
| WBC count; Week 26; n=48, 50, 53, 45 | 5.30 ± 1.294 | 5.50 ± 1.642 | 5.29 ± 1.315 | 5.08 ± 1.381 |
| WBC count; Week 28; n=50, 52, 52, 45 | 5.71 ± 1.426 | 5.53 ± 1.493 | 5.38 ± 1.542 | 5.14 ± 1.254 |
| WBC count; Week 32; n=51, 53, 55, 45 | 5.30 ± 1.399 | 5.63 ± 1.456 | 5.57 ± 1.720 | 5.48 ± 1.939 |
| WBC count; Week 36; n=52, 53, 55, 44 | 5.64 ± 1.461 | 5.48 ± 1.756 | 5.56 ± 1.303 | 5.17 ± 1.312 |
| WBC count; Week 40; n=51, 53, 55, 45 | 5.63 ± 1.607 | 5.61 ± 1.687 | 5.45 ± 1.255 | 5.51 ± 1.808 |
| WBC count; Week 48; n=51, 53, 54, 44 | 5.51 ± 1.663 | 5.72 ± 1.695 | 5.41 ± 1.314 | 5.53 ± 1.818 |
| WBC count; Week 60; n=48, 47, 52, 44 | 5.73 ± 1.749 | 5.93 ± 1.677 | 5.63 ± 1.491 | 5.75 ± 1.608 |
| WBC count; Week 72; n=47, 48, 52, 42 | 5.80 ± 1.671 | 5.71 ± 1.550 | 5.73 ± 1.297 | 5.84 ± 2.104 |
| WBC count; Week 84; n=46, 48, 51, 42 | 5.91 ± 1.845 | 6.11 ± 1.718 | 6.05 ± 1.469 | 5.78 ± 1.658 |
| WBC count; Week 96; n=46, 46, 52, 41 | 6.14 ± 1.622 | 6.15 ± 1.933 | 6.01 ± 1.489 | 5.75 ± 1.556 |
Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
| International Units per Liter | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| ALT; Week 2; n=58, 56, 58, 58 | 0.1 ± 7.47 | -2.1 ± 12.74 | -1.5 ± 14.75 | -1.3 ± 23.63 |
| ALT; Week 4; n=58, 57, 59, 57 | -0.7 ± 8.94 | -2.6 ± 12.13 | 1.7 ± 22.01 | 0.1 ± 29.43 |
| ALT; Week 8; n=58, 55, 57, 54 | 2.2 ± 10.71 | 0.5 ± 18.49 | 8.0 ± 56.59 | -6.3 ± 29.64 |
| ALT; Week 12; n=58, 53, 57, 51 | 1.2 ± 8.91 | 2.7 ± 24.70 | -0.6 ± 13.40 | -6.3 ± 33.57 |
| ALT; Week 16; n=57, 54, 57, 52 | 2.1 ± 19.92 | 0.1 ± 27.07 | -0.3 ± 13.36 | -1.6 ± 38.90 |
| ALT; Week 20; n=56, 54, 55, 49 | -0.7 ± 8.58 | -3.6 ± 14.07 | 3.0 ± 18.56 | -4.8 ± 34.09 |
| ALT; Week 24; n=56, 53, 56, 47 | -2.1 ± 7.93 | -1.2 ± 20.79 | 1.4 ± 19.49 | -6.0 ± 33.13 |
| ALT; Week 26; n=48, 50, 53, 45 | 1.1 ± 16.32 | -2.6 ± 24.31 | -1.7 ± 13.07 | -3.7 ± 41.02 |
| ALT; Week 28; n=51, 52, 52, 45 | -2.3 ± 7.87 | -2.3 ± 25.40 | -2.9 ± 17.79 | -8.1 ± 33.92 |
| ALT; Week 32; n=52, 53, 55, 45 | -3.1 ± 8.55 | -1.7 ± 25.75 | -4.0 ± 13.90 | -8.6 ± 34.85 |
| ALT; Week 36; n=52, 52, 55, 45 | 0.8 ± 23.68 | -4.2 ± 17.84 | -3.0 ± 15.31 | -8.2 ± 32.34 |
| ALT; Week 40; n=52, 53, 55, 44 | 0.1 ± 15.48 | -4.1 ± 15.85 | -1.4 ± 15.96 | -8.0 ± 32.36 |
| ALT; Week 48; n=51, 53, 54, 44 | -4.1 ± 9.03 | -3.8 ± 17.77 | -2.4 ± 14.60 | -8.6 ± 34.80 |
| ALT; Week 60; n=48, 47, 53, 44 | -1.0 ± 15.72 | -2.6 ± 17.74 | 0.5 ± 18.13 | -6.3 ± 36.82 |
| ALT; Week 72; n=47, 47, 52, 42 | -2.8 ± 9.92 | 2.7 ± 30.95 | -0.9 ± 15.27 | -8.5 ± 36.32 |
| ALT; Week 84; n=46, 48, 52, 42 | -2.4 ± 10.87 | 1.9 ± 22.60 | -2.0 ± 16.90 | -4.0 ± 49.06 |
| ALT; Week 96; n=45, 48, 52, 40 | -0.4 ± 18.47 | 20.6 ± 154.71 | -1.7 ± 17.12 | -7.6 ± 20.22 |
| ALT; Week 108; n=43, 46, 48, 0 | 0.5 ± 11.41 | -2.7 ± 20.04 | -0.7 ± 20.63 | — |
| ALT; Week 120; n=40, 45, 48, 0 | 4.4 ± 23.14 | -2.6 ± 18.42 | -3.7 ± 15.82 | — |
| ALT; Week 132; n=40, 46, 49, 0 | 4.3 ± 23.58 | -3.0 ± 20.18 | -3.8 ± 17.80 | — |
| ALT; Week 144; n=37, 45, 47, 0 | 0.1 ± 13.01 | -3.4 ± 17.81 | -1.8 ± 15.40 | — |
| ALT; Week 156; n=37, 42, 49, 0 | -0.5 ± 13.86 | -1.8 ± 19.51 | -2.2 ± 27.94 | — |
| ALT; Week 168; n=35, 43, 47, 0 | 2.3 ± 11.40 | -1.1 ± 19.14 | -3.6 ± 24.29 | — |
| ALT; Week 180; n=36, 41, 47, 0 | 1.7 ± 12.96 | -2.8 ± 15.68 | -1.2 ± 31.69 | — |
| ALT; Week 192; n=36, 39, 47, 0 | 4.9 ± 17.56 | -3.3 ± 16.07 | 1.3 ± 35.53 | — |
| ALT; Week 204; n=34, 39, 47, 0 | 1.9 ± 11.42 | -1.7 ± 16.25 | -3.4 ± 24.00 | — |
| ALT; Week 216; n=33, 39, 46, 0 | 1.7 ± 11.28 | -3.0 ± 13.37 | -2.7 ± 26.90 | — |
| ALT; Week 228; n=32, 39, 47, 0 | 36.8 ± 162.51 | -1.1 ± 13.68 | 0.5 ± 17.72 | — |
| ALT; Week 240; n=30, 39, 46, 0 | 5.3 ± 38.37 | -0.1 ± 16.56 | -0.7 ± 18.20 | — |
| ALT; Week 252; n=31, 38, 46, 0 | 2.0 ± 18.06 | 2.8 ± 22.54 | -1.6 ± 20.95 | — |
| ALT; Week 264; n=32, 38, 47, 0 | 3.3 ± 19.88 | 0.7 ± 23.29 | 2.0 ± 29.60 | — |
| ALT; Week 276; n=31, 38, 45, 0 | 3.3 ± 19.97 | 2.9 ± 31.30 | 1.1 ± 23.92 | — |
| ALT; Week 288; n=31, 38, 45, 0 | 6.6 ± 24.89 | 1.2 ± 27.16 | 1.9 ± 26.19 | — |
| ALT; Week 300; n=30, 37, 44, 0 | 4.8 ± 25.46 | -1.4 ± 19.21 | -1.8 ± 24.06 | — |
| ALT; Week 312; n=31, 34, 43, 0 | 5.5 ± 25.29 | 7.6 ± 42.61 | 0.0 ± 22.51 | — |
| ALT; Week 324; n=3, 4, 3, 0 | 17.7 ± 40.15 | 1.3 ± 8.73 | 1.0 ± 4.36 | — |
| AST; Week 2; n=58, 56, 58, 58 | 0.7 ± 6.11 | -1.3 ± 11.20 | -1.6 ± 8.85 | 0.9 ± 58.63 |
| AST; Week 4; n=58, 57, 59, 57 | -1.0 ± 5.96 | -2.8 ± 8.97 | 0.1 ± 14.56 | -2.9 ± 31.52 |
| AST; Week 8; n=58, 55, 57, 54 | 4.2 ± 30.51 | 1.5 ± 22.15 | 5.3 ± 36.86 | -7.3 ± 29.65 |
| AST; Week 12; n=58, 53, 57, 50 | 1.3 ± 10.43 | 1.6 ± 21.65 | -1.7 ± 8.91 | -7.9 ± 32.18 |
| AST; Week 16; n=57, 54, 57, 52 | -0.7 ± 10.43 | 1.9 ± 23.46 | -0.6 ± 8.03 | 4.4 ± 79.53 |
| AST; Week 20; n=56, 54, 55, 49 | 1.3 ± 18.94 | -3.1 ± 10.44 | 4.6 ± 23.87 | -3.6 ± 41.56 |
| AST; Week 24; n=56, 53, 56, 47 | -1.4 ± 7.81 | -0.3 ± 15.64 | 1.5 ± 15.03 | -2.1 ± 13.59 |
| AST; Week 26; n=48, 50, 53, 45 | 3.3 ± 28.47 | -0.9 ± 16.10 | -1.7 ± 8.21 | -2.6 ± 17.81 |
| AST; Week 28; n=51, 52, 52, 45 | -2.0 ± 6.39 | -0.2 ± 15.51 | -1.9 ± 13.67 | -5.1 ± 15.42 |
| AST; Week 32; n=52, 53, 55, 45 | -2.7 ± 5.77 | -1.0 ± 16.15 | -1.4 ± 9.19 | -2.8 ± 17.86 |
| AST; Week 36; n=52, 52, 55, 45 | 4.6 ± 38.77 | -2.1 ± 12.13 | -0.6 ± 11.86 | -1.9 ± 17.93 |
| AST; Week 40; n=52, 53, 55, 44 | 0.1 ± 13.12 | -2.9 ± 10.87 | -0.5 ± 14.40 | -5.1 ± 14.94 |
| AST; Week 48; n=51, 53, 54, 44 | -3.3 ± 7.99 | -3.2 ± 12.28 | -3.0 ± 8.28 | -4.4 ± 16.67 |
| AST; Week 60; n=48, 47, 53, 44 | -0.9 ± 9.05 | -2.0 ± 13.06 | 3.0 ± 18.70 | -3.2 ± 17.49 |
| AST; Week 72; n=47, 47, 52, 42 | -2.7 ± 6.70 | 3.7 ± 24.41 | -0.5 ± 9.75 | -4.6 ± 15.69 |
| AST; Week 84; n=46, 48, 52, 42 | -2.2 ± 7.56 | 2.0 ± 19.02 | -1.8 ± 9.46 | 2.3 ± 40.93 |
| AST; Week 96; n=45, 48, 52, 40 | -0.8 ± 22.39 | 20.5 ± 150.10 | -1.0 ± 12.58 | -0.3 ± 25.99 |
| AST; Week 108; n=43, 46, 48, 0 | -1.0 ± 10.89 | -4.0 ± 11.71 | 0.6 ± 22.77 | — |
| AST; Week 120; n=40, 45, 48, 0 | 0.1 ± 13.16 | -2.5 ± 13.44 | -2.4 ± 10.90 | — |
| AST; Week 132; n=40, 46, 49, 0 | -0.2 ± 11.50 | -3.9 ± 12.40 | 0.7 ± 32.61 | — |
| AST; Week 144; n=37, 45, 47, 0 | -3.4 ± 8.19 | -4.3 ± 13.76 | -3.9 ± 9.45 | — |
| AST; Week 156; n=37, 42, 49, 0 | -3.0 ± 8.78 | -3.2 ± 13.94 | -4.1 ± 13.08 | — |
| AST; Week 168; n=35, 43, 47, 0 | -0.8 ± 8.95 | -3.4 ± 12.15 | -3.8 ± 13.44 | — |
| AST; Week 180; n=36, 41, 47, 0 | -1.9 ± 7.91 | -4.2 ± 12.71 | -2.9 ± 17.09 | — |
| AST; Week 192; n=36, 39, 47, 0 | -1.5 ± 8.89 | -5.3 ± 11.00 | 0.1 ± 20.52 | — |
| AST; Week 204; n=34, 39, 47, 0 | -1.7 ± 7.88 | -4.8 ± 10.98 | -4.5 ± 12.04 | — |
| AST; Week 216; n=33, 39, 46, 0 | -2.7 ± 6.40 | -4.9 ± 11.54 | -4.3 ± 13.42 | — |
| AST; Week 228; n=32, 39, 47, 0 | 13.5 ± 72.97 | -5.9 ± 11.78 | -2.8 ± 10.14 | — |
| AST; Week 240; n=30, 39, 46, 0 | -1.0 ± 21.51 | -5.3 ± 11.70 | -3.4 ± 11.32 | — |
| AST; Week 252; n=31, 38, 46, 0 | -2.2 ± 10.89 | -2.1 ± 15.31 | -3.9 ± 11.09 | — |
| AST; Week 264; n=32, 38, 47, 0 | -1.6 ± 10.61 | -4.3 ± 15.09 | -2.9 ± 12.87 | — |
| AST; Week 276; n=31, 38, 45, 0 | -1.5 ± 10.00 | -3.3 ± 14.38 | -1.4 ± 12.80 | — |
| AST; Week 288; n=31, 38, 45, 0 | -1.4 ± 11.87 | -3.6 ± 14.93 | -2.2 ± 12.98 | — |
| AST; Week 300; n=30, 37, 44, 0 | -2.0 ± 9.56 | -5.3 ± 13.01 | -4.1 ± 12.07 | — |
| AST; Week 312; n=31, 34, 43, 0 | 11.7 ± 82.61 | -2.3 ± 17.39 | -0.3 ± 14.27 | — |
| AST; Week 324; n=3, 4, 3, 0 | 2.7 ± 12.66 | -5.3 ± 14.59 | -6.7 ± 4.16 | — |
| CK; Week 2; n=58, 56, 58, 58 | 40.0 ± 234.19 | -32.2 ± 664.29 | 0.4 ± 183.47 | 159.8 ± 3217.64 |
| CK; Week 4; n=58, 57, 59, 57 | -2.3 ± 125.78 | -82.0 ± 586.36 | -2.9 ± 227.73 | -120.3 ± 1656.37 |
| CK; Week 8; n=58, 55, 57, 54 | 216.9 ± 1495.44 | 115.8 ± 1625.63 | 266.7 ± 1787.23 | -212.8 ± 1579.19 |
| CK; Week 12; n=58, 53, 57, 51 | 120.6 ± 551.72 | 39.8 ± 1035.75 | 27.1 ± 208.15 | -220.1 ± 1656.33 |
| CK; Week 16; n=57, 54, 57, 52 | -2.0 ± 177.01 | 156.3 ± 1399.82 | 28.6 ± 218.04 | 269.7 ± 3855.01 |
| CK; Week 20; n=56, 54, 55, 49 | 144.2 ± 969.11 | -68.9 ± 542.73 | 298.9 ± 1661.14 | 135.3 ± 3115.23 |
| CK; Week 24; n=56, 53, 56, 47 | 27.5 ± 241.96 | 32.4 ± 800.50 | 55.9 ± 252.05 | 103.9 ± 482.18 |
| CK; Week 26; n=48, 50, 53, 45 | 133.7 ± 612.97 | -16.3 ± 616.41 | 54.4 ± 316.26 | 21.2 ± 162.22 |
| CK; Week 28; n=51, 52, 52, 45 | 9.8 ± 179.35 | 74.1 ± 542.07 | 96.8 ± 475.89 | 4.1 ± 159.24 |
| CK; Week 32; n=52, 53, 55, 45 | 3.1 ± 159.46 | -25.1 ± 605.67 | 122.1 ± 364.15 | 110.3 ± 794.67 |
| CK; Week 36; n=52, 52, 55, 45 | 325.9 ± 1995.64 | -33.6 ± 572.93 | 66.1 ± 276.38 | 158.7 ± 625.32 |
| CK; Week 40; n=52, 53, 55, 44 | 57.1 ± 350.15 | -48.6 ± 502.19 | 103.5 ± 390.10 | 3.8 ± 128.31 |
| CK; Week 48; n=51, 53, 54, 44 | -1.3 ± 173.80 | -54.7 ± 612.26 | 28.6 ± 196.37 | 2.8 ± 124.04 |
| CK; Week 60; n=48, 47, 53, 44 | 115.4 ± 743.67 | -80.1 ± 598.41 | 206.2 ± 880.62 | 24.5 ± 158.37 |
| CK; Week 72; n=47, 47, 52, 42 | -19.8 ± 152.46 | 53.8 ± 1031.26 | 67.6 ± 311.66 | -14.3 ± 92.49 |
| CK; Week 84; n=46, 48, 52, 42 | -0.7 ± 147.67 | 33.6 ± 900.48 | 14.9 ± 211.36 | 123.9 ± 598.22 |
| CK; Week 96; n=45, 48, 52, 40 | 335.4 ± 2431.93 | -22.8 ± 768.54 | 19.6 ± 249.41 | 143.9 ± 903.29 |
| CK; Week 108; n=43, 46, 48, 0 | 64.2 ± 339.96 | -88.5 ± 592.61 | 100.3 ± 546.46 | — |
| CK; Week 120; n=40, 45, 48, 0 | 11.5 ± 229.39 | -48.9 ± 614.32 | 61.4 ± 304.98 | — |
| CK; Week 132; n=40, 46, 49, 0 | 30.6 ± 198.34 | -41.3 ± 654.65 | 649.6 ± 3895.73 | — |
| CK; Week 144; n=37, 45, 47, 0 | 10.6 ± 143.04 | -72.4 ± 637.65 | 68.7 ± 192.20 | — |
| CK; Week 156; n=37, 42, 49, 0 | -5.3 ± 178.55 | -87.9 ± 626.53 | 73.3 ± 396.95 | — |
| CK; Week 168; n=35, 43, 47, 0 | 27.7 ± 149.18 | -60.7 ± 648.64 | 74.4 ± 492.75 | — |
| CK; Week 180; n=36, 41, 47, 0 | 22.4 ± 120.72 | -16.4 ± 769.12 | 62.8 ± 325.34 | — |
| CK; Week 192; n=36, 39, 47, 0 | 5.2 ± 123.98 | -98.5 ± 666.21 | 98.6 ± 393.41 | — |
| CK; Week 204; n=34, 39, 47, 0 | 79.1 ± 253.58 | -101.8 ± 642.05 | 48.3 ± 148.37 | — |
| CK; Week 216; n=33, 39, 46, 0 | 43.2 ± 232.12 | -74.4 ± 658.64 | 41.9 ± 177.16 | — |
| CK; Week 228; n=32, 39, 47, 0 | 64.0 ± 332.07 | -129.0 ± 640.89 | 40.4 ± 133.68 | — |
| CK; Week 240; n=30, 39, 46, 0 | 1.2 ± 118.21 | -108.1 ± 646.43 | 92.0 ± 285.12 | — |
| CK; Week 252; n=31, 38, 46, 0 | 24.6 ± 96.40 | -110.1 ± 645.37 | 62.5 ± 201.59 | — |
| CK; Week 264; n=32, 38, 47, 0 | 1.9 ± 135.22 | -31.3 ± 819.97 | 38.9 ± 137.90 | — |
| CK; Week 276; n=31, 38, 45, 0 | 39.9 ± 258.45 | -126.5 ± 639.63 | 146.4 ± 350.73 | — |
| CK; Week 288; n=31, 38, 45, 0 | 21.6 ± 139.26 | -98.5 ± 642.79 | 43.4 ± 172.08 | — |
| CK; Week 300; n=30, 37, 44, 0 | 25.3 ± 129.65 | -100.7 ± 684.43 | 56.0 ± 195.62 | — |
| CK; Week 312; n=31, 34, 43, 0 | 727.5 ± 4047.61 | -141.3 ± 681.29 | 209.4 ± 862.10 | — |
| CK; Week 324; n=3, 4, 3, 0 | -1.3 ± 168.42 | -195.0 ± 417.89 | 102.7 ± 157.82 | — |
Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
| Micromoles per liter | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Creatinine; Week 2; n=58, 56, 58, 58 | 3.36 ± 7.519 | 2.58 ± 7.273 | 4.15 ± 6.508 | 0.65 ± 7.483 |
| Creatinine; Week 4; n=58, 57, 59, 57 | 2.24 ± 6.889 | 2.50 ± 7.401 | 4.08 ± 8.072 | -0.32 ± 5.817 |
| Creatinine; Week 8; n=58, 55, 57, 54 | 2.38 ± 8.371 | 2.06 ± 6.775 | 3.44 ± 8.717 | -0.92 ± 9.006 |
| Creatinine; Week 12; n=58, 53, 57, 51 | 3.39 ± 8.591 | 1.59 ± 9.300 | 3.79 ± 8.634 | -1.42 ± 9.022 |
| Creatinine; Week 16; n=57, 54, 57, 52 | 2.91 ± 11.874 | 1.10 ± 6.923 | 2.09 ± 8.967 | -2.92 ± 7.744 |
| Creatinine; Week 20; n=56, 54, 55, 49 | 2.54 ± 6.384 | 0.85 ± 7.713 | 5.29 ± 9.360 | -3.26 ± 8.085 |
| Creatinine; Week 24; n=56, 53, 56, 47 | 2.52 ± 7.225 | 2.44 ± 9.391 | 4.45 ± 9.743 | -2.03 ± 15.306 |
| Creatinine; Week 26; n=48, 50, 53, 45 | 2.74 ± 7.750 | 1.80 ± 8.796 | 6.03 ± 8.465 | -2.67 ± 9.311 |
| Creatinine; Week 28; n=51, 52, 52, 45 | 2.22 ± 6.606 | 2.80 ± 8.908 | 5.01 ± 9.028 | -3.42 ± 8.042 |
| Creatinine; Week 32; n=52, 53, 55, 45 | 3.36 ± 8.462 | 1.69 ± 9.226 | 5.00 ± 8.690 | -3.50 ± 7.887 |
| Creatinine; Week 36; n=52, 52, 55, 45 | 3.11 ± 6.652 | 3.41 ± 8.115 | 6.00 ± 8.059 | -3.26 ± 7.392 |
| Creatinine; Week 40; n=52, 53, 55, 44 | 2.83 ± 7.966 | 2.36 ± 8.318 | 4.76 ± 7.858 | -2.83 ± 9.423 |
| Creatinine; Week 48; n=51, 53, 54, 44 | 2.75 ± 9.061 | 2.18 ± 8.280 | 4.47 ± 7.883 | -2.73 ± 8.533 |
| Creatinine; Week 60; n=48, 47, 53, 44 | 3.28 ± 7.507 | 2.30 ± 7.998 | 4.46 ± 9.058 | -3.87 ± 7.866 |
| Creatinine; Week 72; n=47, 47, 52, 42 | 3.89 ± 7.917 | 4.71 ± 7.934 | 6.59 ± 10.595 | -4.48 ± 8.461 |
| Creatinine; Week 84; n=46, 48, 52, 42 | 4.58 ± 9.834 | 3.80 ± 8.761 | 6.53 ± 8.328 | -2.48 ± 8.697 |
| Creatinine; Week 96; n=45, 48, 52, 40 | 1.90 ± 11.248 | 5.34 ± 10.813 | 7.76 ± 10.318 | -2.28 ± 10.222 |
| Creatinine; Week 108; n=43, 46, 48, 0 | 5.87 ± 9.133 | 5.18 ± 7.296 | 7.26 ± 10.273 | — |
| Creatinine; Week 120; n=40, 45, 48, 0 | 4.41 ± 8.648 | 4.15 ± 7.099 | 6.78 ± 11.811 | — |
| Creatinine; Week 132; n=40, 46, 49, 0 | 3.76 ± 8.272 | 4.02 ± 6.551 | 4.99 ± 12.168 | — |
| Creatinine; Week 144; n=37, 45, 47, 0 | 5.99 ± 11.083 | 5.80 ± 6.861 | 5.07 ± 10.449 | — |
| Creatinine; Week 156; n=37, 42, 49, 0 | 5.28 ± 8.225 | 6.36 ± 6.819 | 5.16 ± 9.056 | — |
| Creatinine; Week 168; n=35, 43, 47, 0 | 6.57 ± 8.702 | 5.62 ± 8.355 | 6.82 ± 9.644 | — |
| Creatinine; Week 180; n=36, 41, 47, 0 | 5.89 ± 6.964 | 5.08 ± 7.638 | 5.91 ± 11.737 | — |
| Creatinine; Week 192; n=36, 39, 47, 0 | 6.90 ± 9.792 | 7.91 ± 9.528 | 5.90 ± 11.316 | — |
| Creatinine; Week 204; n=34, 39, 47, 0 | 6.21 ± 9.019 | 6.46 ± 8.491 | 5.16 ± 10.629 | — |
| Creatinine; Week 216; n=33, 39, 46, 0 | 8.34 ± 7.736 | 9.31 ± 10.863 | 7.42 ± 8.996 | — |
| Creatinine; Week 228; n=32, 39, 47, 0 | 7.16 ± 10.365 | 7.19 ± 7.388 | 6.61 ± 10.415 | — |
| Creatinine; Week 240; n=30, 39, 46, 0 | 8.48 ± 10.016 | 7.33 ± 9.459 | 7.08 ± 10.649 | — |
| Creatinine; Week 252; n=31, 38, 46, 0 | 6.96 ± 8.206 | 7.52 ± 9.245 | 7.64 ± 11.727 | — |
| Creatinine; Week 264; n=32, 38, 47, 0 | 5.97 ± 7.510 | 7.10 ± 9.486 | 6.99 ± 12.140 | — |
| Creatinine; Week 276; n=31, 38, 45, 0 | 7.89 ± 8.309 | 5.84 ± 10.581 | 6.19 ± 10.418 | — |
| Creatinine; Week 288; n=31, 38, 45, 0 | 8.81 ± 8.348 | 7.84 ± 9.546 | 6.20 ± 12.890 | — |
| Creatinine; Week 300; n=30, 37, 44, 0 | 10.49 ± 8.321 | 9.16 ± 9.580 | 8.19 ± 12.114 | — |
| Creatinine; Week 312; n=31, 34, 43, 0 | 7.98 ± 8.645 | 7.86 ± 9.096 | 7.10 ± 12.061 | — |
| Creatinine; Week 324; n=3, 4, 3, 0 | 15.90 ± 6.636 | 9.75 ± 8.155 | 5.03 ± 4.007 | — |
| T. Bilirubin; Week 2; n=58, 56, 58, 58 | 0.0 ± 3.20 | -0.3 ± 2.71 | -0.4 ± 4.89 | -3.0 ± 3.82 |
| T. Bilirubin; Week 4; n=58, 57, 59, 57 | 0.1 ± 3.39 | -0.3 ± 3.90 | -0.8 ± 5.90 | -3.4 ± 4.06 |
| T. Bilirubin; Week 8; n=58, 55, 57, 54 | 0.0 ± 3.99 | -0.5 ± 3.83 | -0.6 ± 5.62 | -3.4 ± 4.24 |
| T. Bilirubin; Week 12; n=58, 53, 57, 51 | 0.4 ± 5.43 | -0.9 ± 3.77 | -0.5 ± 5.61 | -2.4 ± 3.75 |
| T. Bilirubin; Week 16; n=57, 54, 57, 52 | 0.4 ± 3.96 | -1.2 ± 3.74 | -0.2 ± 4.93 | -2.4 ± 3.79 |
| T. Bilirubin; Week 20; n=56, 54, 55, 49 | -0.1 ± 3.96 | -0.7 ± 3.63 | -0.4 ± 7.27 | -2.6 ± 3.83 |
| T. Bilirubin; Week 24; n=56, 53, 56, 47 | 0.5 ± 4.26 | 0.2 ± 4.45 | -0.7 ± 5.69 | -2.9 ± 3.86 |
| T. Bilirubin; Week 26; n=48, 50, 53, 45 | 1.1 ± 4.97 | 0.5 ± 3.81 | 1.0 ± 5.80 | -2.7 ± 3.44 |
| T. Bilirubin; Week 28; n=51, 52, 52, 45 | 1.1 ± 4.39 | 0.7 ± 5.19 | 0.5 ± 5.25 | -2.8 ± 4.01 |
| T. Bilirubin; Week 32; n=52, 53, 55, 45 | 0.7 ± 3.79 | 0.2 ± 4.99 | 0.9 ± 6.82 | -2.6 ± 3.78 |
| T. Bilirubin; Week 36; n=52, 52, 55, 45 | 1.2 ± 4.94 | 0.6 ± 4.92 | 1.4 ± 6.40 | -2.7 ± 3.62 |
| T. Bilirubin; Week 40; n=52, 53, 55, 44 | 1.6 ± 5.03 | 1.7 ± 4.75 | 1.5 ± 6.30 | -2.9 ± 3.67 |
| T. Bilirubin; Week 48; n=51, 53, 54, 44 | 0.9 ± 4.58 | 0.1 ± 4.51 | -0.3 ± 5.37 | -2.6 ± 3.80 |
| T. Bilirubin; Week 60; n=48, 47, 53, 44 | 1.9 ± 4.31 | 0.0 ± 4.78 | 0.9 ± 6.56 | -2.2 ± 3.86 |
| T. Bilirubin; Week 72; n=47, 47, 52, 42 | 1.5 ± 6.05 | 0.1 ± 4.59 | 0.6 ± 6.36 | -2.7 ± 3.69 |
| T. Bilirubin; Week 84; n=46, 48, 52, 42 | 2.3 ± 5.09 | 0.1 ± 5.07 | 1.2 ± 5.49 | -2.6 ± 4.27 |
| T. Bilirubin; Week 96; n=45, 48, 52, 40 | 1.0 ± 4.15 | 0.0 ± 5.80 | 1.7 ± 5.42 | -2.5 ± 3.92 |
| T. Bilirubin; Week 108; n=43, 46, 48, 0 | 0.7 ± 4.86 | 1.4 ± 6.34 | 0.8 ± 5.89 | — |
| T. Bilirubin; Week 120; n=40, 45, 48, 0 | 0.9 ± 4.96 | 1.1 ± 4.72 | 1.3 ± 7.40 | — |
| T. Bilirubin; Week 132; n=40, 46, 49, 0 | 1.0 ± 6.16 | 2.0 ± 8.03 | 1.1 ± 6.40 | — |
| T. Bilirubin; Week 144; n=37, 45, 47, 0 | 0.7 ± 4.70 | 1.1 ± 7.00 | 0.4 ± 6.50 | — |
| T. Bilirubin; Week 156; n=37, 42, 49, 0 | 1.6 ± 5.07 | 1.0 ± 5.23 | 1.0 ± 6.93 | — |
| T. Bilirubin; Week 168; n=35, 43, 47, 0 | 1.1 ± 5.37 | 0.8 ± 4.19 | 1.4 ± 5.94 | — |
| T. Bilirubin; Week 180; n=36, 41, 47, 0 | 1.1 ± 5.54 | 0.0 ± 4.29 | 1.0 ± 7.42 | — |
| T. Bilirubin; Week 192; n=36, 39, 47, 0 | 0.7 ± 5.88 | 0.3 ± 4.80 | 0.9 ± 6.18 | — |
| T. Bilirubin; Week 204; n=34, 39, 47, 0 | 1.1 ± 5.31 | 0.7 ± 3.71 | 0.6 ± 6.61 | — |
| T. Bilirubin; Week 216; n=33, 39, 46, 0 | 0.5 ± 5.08 | 0.8 ± 6.69 | 0.3 ± 5.91 | — |
| T. Bilirubin; Week 228; n=32, 39, 47, 0 | 1.6 ± 4.61 | 0.5 ± 3.77 | -0.3 ± 5.71 | — |
| T. Bilirubin; Week 240; n=30, 39, 46, 0 | 1.2 ± 4.92 | 0.9 ± 4.72 | -0.1 ± 4.83 | — |
| T. Bilirubin; Week 252; n=31, 38, 46, 0 | 1.4 ± 5.71 | 2.0 ± 6.03 | 0.2 ± 6.21 | — |
| T. Bilirubin; Week 264; n=32, 38, 47, 0 | 0.4 ± 5.76 | 2.9 ± 8.95 | -0.1 ± 6.11 | — |
| T. Bilirubin; Week 276; n=31, 38, 45, 0 | 0.7 ± 3.52 | 2.8 ± 10.40 | 0.9 ± 6.46 | — |
| T. Bilirubin; Week 288; n=31, 38, 45, 0 | 0.5 ± 5.06 | 1.9 ± 7.87 | 0.0 ± 6.10 | — |
| T. Bilirubin; Week 300; n=30, 37, 44, 0 | 1.1 ± 4.22 | 1.7 ± 8.78 | 0.9 ± 5.18 | — |
| T. Bilirubin; Week 312; n=31, 34, 43, 0 | 1.4 ± 5.30 | 1.1 ± 7.12 | 0.8 ± 5.52 | — |
| T. Bilirubin; Week 324; n=3, 4, 3, 0 | 5.3 ± 4.16 | 5.5 ± 11.47 | 0.7 ± 4.16 | — |
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
| Milliliters per minute | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Week 2; n=1, 1, 0, 3 | -3.0 ± NA | -10.0 ± NA | — | -0.7 ± 0.58 |
| Week 4; n=58, 57, 59, 57 | -1.4 ± 12.20 | -3.7 ± 12.18 | -4.9 ± 14.83 | -0.1 ± 10.06 |
| Week 8; n=2, 1, 1, 1 | 5.5 ± 26.16 | -1.0 ± NA | 7.0 ± NA | 0.0 ± NA |
| Week 16; n=55, 53, 56, 49 | 2.2 ± 37.66 | 0.2 ± 15.60 | -2.7 ± 13.89 | 3.4 ± 12.94 |
| Week 20; n=2, 0, 0, 1 | 8.0 ± 7.07 | — | — | 4.0 ± NA |
| Week 24; n=52, 53, 55, 46 | -2.7 ± 22.03 | -6.4 ± 34.13 | -5.8 ± 14.77 | 4.8 ± 15.66 |
| Week 26; n=0, 1, 0, 0 | — | -7.0 ± NA | — | — |
| Week 40; n=0, 1, 0, 0 | — | -95.0 ± NA | — | — |
| Week 48; n=51, 50, 54, 44 | -2.6 ± 12.72 | -1.1 ± 16.63 | -4.5 ± 14.27 | 0.4 ± 19.04 |
| Week 60; n=0, 0, 0, 1 | — | — | — | 16.0 ± NA |
| Week 96; n=45, 48, 52, 40 | 2.2 ± 31.70 | -2.4 ± 20.43 | -9.0 ± 16.95 | 5.1 ± 22.48 |
| Week 180; n=1, 0, 0, 0 | 1.0 ± NA | — | — | — |
| Week 204; n=0, 1, 0, 0 | — | -23.0 ± NA | — | — |
| Week 252; n=0, 1, 0, 0 | — | 0.0 ± NA | — | — |
| Week 264; n=0, 0, 1, 0 | — | — | -143.0 ± NA | — |
Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
| Grams per liter | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Week 2; n=57, 56, 59, 59 | 0.1 ± 6.66 | 0.0 ± 6.25 | -0.7 ± 6.61 | 0.7 ± 6.90 |
| Week 4; n=57, 57, 59, 57 | -0.2 ± 6.41 | 0.5 ± 5.61 | 0.6 ± 7.67 | 0.7 ± 6.40 |
| Week 8; n=58, 56, 56, 55 | 2.7 ± 9.19 | 4.8 ± 7.23 | 2.0 ± 8.99 | 2.0 ± 9.18 |
| Week 12; n=58, 53, 57, 51 | 2.0 ± 8.27 | 3.9 ± 7.84 | 2.6 ± 9.59 | 2.8 ± 8.57 |
| Week 16; n=57, 54, 57, 52 | 1.1 ± 7.58 | 3.5 ± 7.55 | 2.3 ± 9.61 | 1.1 ± 9.22 |
| Week 20; n=56, 54, 55, 49 | 2.1 ± 8.78 | 3.8 ± 9.28 | 3.1 ± 9.66 | 0.8 ± 9.22 |
| Week 24; n=56, 53, 56, 47 | 2.6 ± 9.17 | 4.8 ± 7.66 | 3.6 ± 11.04 | 1.9 ± 8.16 |
| Week 26; n=48, 50, 53, 45 | 1.8 ± 7.68 | 3.4 ± 8.00 | 2.5 ± 9.17 | 2.2 ± 8.11 |
| Week 28; n=50, 52, 52, 45 | 1.7 ± 8.51 | 4.0 ± 7.93 | 1.5 ± 8.50 | 0.1 ± 10.50 |
| Week 32; n=51, 53, 55, 45 | 1.6 ± 8.64 | 3.1 ± 8.71 | 3.5 ± 8.49 | 0.6 ± 8.92 |
| Week 36; n=52, 53, 55, 44 | 0.3 ± 10.21 | 2.9 ± 9.69 | 2.7 ± 11.59 | -0.8 ± 9.79 |
| Week 40; n=51, 53, 55, 45 | 0.5 ± 11.44 | 2.2 ± 8.56 | 2.1 ± 9.46 | -0.2 ± 7.67 |
| Week 48; n=51, 53, 54, 44 | 1.2 ± 9.84 | 2.7 ± 8.40 | -0.5 ± 12.03 | 0.0 ± 9.52 |
| Week 60; n=48, 47, 52, 44 | 2.6 ± 11.23 | 4.7 ± 8.73 | 2.2 ± 11.45 | 2.3 ± 9.18 |
| Week 72; n=47, 48, 52, 42 | 1.8 ± 11.28 | 4.5 ± 7.39 | 2.4 ± 10.08 | 2.4 ± 9.15 |
| Week 84; n=46, 48, 51, 42 | 3.3 ± 11.53 | 4.0 ± 8.37 | 3.0 ± 11.34 | 1.7 ± 9.65 |
| Week 96; n=46, 46, 52, 41 | 2.7 ± 13.41 | 3.3 ± 6.94 | 3.6 ± 10.11 | 1.9 ± 10.06 |
| Week 108; n=43, 46, 49, 0 | 4.0 ± 11.77 | 3.4 ± 9.42 | 3.0 ± 10.98 | — |
| Week 120; n=41, 46, 49, 0 | 4.2 ± 11.11 | 4.7 ± 8.72 | 2.1 ± 11.39 | — |
| Week 132; n=40, 46, 49, 0 | 3.5 ± 10.89 | 3.0 ± 9.90 | 2.5 ± 12.41 | — |
| Week 144; n=37, 45, 46, 0 | 4.0 ± 12.08 | 2.6 ± 10.64 | 2.3 ± 11.37 | — |
| Week 156; n=37, 42, 49, 0 | 4.0 ± 11.55 | 5.1 ± 9.76 | 2.7 ± 11.88 | — |
| Week 168; n=35, 43, 47, 0 | 6.3 ± 12.60 | 6.0 ± 10.91 | 4.8 ± 10.60 | — |
| Week 180; n=36, 41, 47, 0 | 5.5 ± 11.79 | 4.0 ± 9.23 | 2.7 ± 11.68 | — |
| Week 192; n=35, 40, 47, 0 | 3.3 ± 13.07 | 3.5 ± 9.55 | 3.0 ± 11.51 | — |
| Week 204; n=34, 39, 47, 0 | 4.5 ± 12.73 | 4.7 ± 9.84 | 3.2 ± 11.65 | — |
| Week 216; n=32, 39, 44, 0 | 4.7 ± 14.10 | 4.1 ± 9.97 | 3.4 ± 10.60 | — |
| Week 228; n=31, 39, 47, 0 | 5.1 ± 13.32 | 4.8 ± 10.55 | 3.1 ± 10.53 | — |
| Week 240; n=32, 39, 47, 0 | 6.2 ± 14.38 | 5.8 ± 10.64 | 2.1 ± 11.70 | — |
| Week 252; n=31, 36, 45, 0 | 6.2 ± 14.98 | 6.4 ± 11.76 | 5.8 ± 10.33 | — |
| Week 264; n=32, 38, 46, 0 | 6.3 ± 14.69 | 6.0 ± 9.28 | 5.5 ± 11.07 | — |
| Week 276; n=31, 38, 46, 0 | 6.6 ± 14.67 | 5.5 ± 11.06 | 5.4 ± 10.02 | — |
| Week 288; n=30, 38, 44, 0 | 7.3 ± 12.51 | 6.8 ± 11.38 | 6.9 ± 10.82 | — |
| Week 300; n=30, 37, 43, 0 | 4.6 ± 15.39 | 5.1 ± 10.47 | 5.5 ± 11.56 | — |
| Week 312; n=31, 33, 42, 0 | 7.0 ± 13.56 | 6.1 ± 9.29 | 8.0 ± 10.10 | — |
| Week 324; n=3, 4, 2, 0 | 4.3 ± 9.07 | 10.0 ± 14.33 | 20.5 ± 7.78 | — |
Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.
| Giga cells per liter | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| T. neutrophils; Week 2; n=57, 56, 59, 59 | 0.042 ± 1.0528 | -0.084 ± 1.4018 | 0.104 ± 1.0318 | 0.716 ± 1.4565 |
| T. neutrophils; Week 4; n=57, 57, 59, 57 | 0.038 ± 1.2691 | -0.083 ± 1.2859 | 0.155 ± 1.0877 | 0.375 ± 1.5303 |
| T. neutrophils; Week 8; n=58, 56, 56, 55 | 0.251 ± 1.0956 | -0.066 ± 1.3186 | 0.341 ± 1.2077 | 0.273 ± 0.8715 |
| T. neutrophils; Week 12; n=58, 53, 57, 51 | 0.138 ± 1.2352 | 0.040 ± 1.4855 | 0.359 ± 1.3585 | 0.525 ± 1.5661 |
| T. neutrophils; Week 16; n=57, 54, 57, 52 | 0.388 ± 1.7066 | -0.156 ± 1.2694 | 0.203 ± 1.0459 | 0.367 ± 1.2022 |
| T. neutrophils; Week 20; n=56, 54, 55, 49 | 0.270 ± 1.3671 | 0.032 ± 1.3837 | 0.525 ± 1.6689 | 0.740 ± 1.7181 |
| T. neutrophils; Week 24; n=56, 53, 56, 47 | 0.462 ± 1.1725 | 0.109 ± 1.7578 | 0.406 ± 1.0404 | 0.637 ± 1.5583 |
| T. neutrophils; Week 26; n=48, 50, 53, 45 | 0.120 ± 0.8908 | 0.052 ± 1.7443 | 0.375 ± 1.1565 | 0.449 ± 1.3271 |
| T. neutrophils; Week 28; n=50, 52, 52, 45 | 0.496 ± 1.1330 | 0.213 ± 1.4523 | 0.502 ± 1.2817 | 0.446 ± 1.1851 |
| T. neutrophils; Week 32; n=51, 53, 55, 45 | 0.071 ± 1.3373 | 0.149 ± 1.5137 | 0.692 ± 1.4994 | 0.717 ± 1.5595 |
| T. neutrophils; Week 36; n=52, 53, 55, 44 | 0.420 ± 1.4246 | 0.029 ± 1.7516 | 0.535 ± 1.0695 | 0.414 ± 1.3998 |
| T. neutrophils; Week 40; n=51, 53, 55, 45 | 0.430 ± 1.4711 | 0.178 ± 1.3099 | 0.575 ± 1.0510 | 0.730 ± 1.4181 |
| T. neutrophils; Week 48; n=51, 53, 54, 44 | 0.386 ± 1.3376 | 0.245 ± 1.5695 | 0.534 ± 1.3432 | 0.665 ± 1.6752 |
| T. neutrophils; Week 60; n=48, 47, 52, 44 | 0.374 ± 1.4938 | 0.458 ± 1.6323 | 0.711 ± 0.9216 | 0.800 ± 1.4058 |
| T. neutrophils; Week 72; n=47, 48, 52, 42 | 0.383 ± 1.6125 | 0.274 ± 1.5663 | 0.666 ± 1.2125 | 0.892 ± 1.9492 |
| T. neutrophils; Week 84; n=46, 48, 51, 42 | 0.410 ± 1.6209 | 0.528 ± 1.6303 | 1.006 ± 1.4287 | 0.790 ± 1.7937 |
| T. neutrophils; Week 96; n=46, 46, 52, 41 | 0.631 ± 1.3478 | 0.698 ± 1.8981 | 0.997 ± 1.3089 | 0.831 ± 1.4347 |
| T. neutrophils; Week 108; n=43, 46, 49, 0 | 0.623 ± 1.7946 | 0.570 ± 1.5706 | 1.006 ± 1.6122 | — |
| T. neutrophils; Week 120; n=41, 46, 49, 0 | 0.372 ± 1.7590 | 0.650 ± 1.8334 | 0.769 ± 1.6486 | — |
| T. neutrophils; Week 132; n=40, 46, 49, 0 | 0.777 ± 2.1995 | 0.405 ± 1.6979 | 0.671 ± 1.0761 | — |
| T. neutrophils; Week 144; n=37, 45, 46, 0 | 0.672 ± 1.3974 | 0.468 ± 1.6210 | 0.831 ± 1.4397 | — |
| T. neutrophils; Week 156; n=37, 42, 49, 0 | 0.762 ± 1.7331 | 0.418 ± 1.6395 | 1.095 ± 1.2219 | — |
| T. neutrophils; Week 168; n=35, 43, 47, 0 | 0.588 ± 1.5738 | 0.534 ± 1.6710 | 1.011 ± 1.2304 | — |
| T. neutrophils; Week 180; n=36, 41, 47, 0 | 0.769 ± 1.4717 | 0.405 ± 1.7183 | 0.840 ± 1.0957 | — |
| T. neutrophils; Week 192; n=35, 40, 47, 0 | 0.490 ± 1.3807 | 0.594 ± 1.7286 | 0.722 ± 1.2591 | — |
| T. neutrophils; Week 204; n=34, 39, 47, 0 | 0.618 ± 1.7745 | 0.648 ± 1.7939 | 0.821 ± 1.4259 | — |
| T. neutrophils; Week 216; n=32, 39, 43, 0 | 0.543 ± 1.7307 | 0.588 ± 1.5854 | 0.914 ± 1.4470 | — |
| T. neutrophils; Week 228; n=30, 39, 47, 0 | 0.780 ± 1.7170 | 0.789 ± 1.6779 | 0.819 ± 1.1182 | — |
| T. neutrophils; Week 240; n=32, 39, 47, 0 | 0.508 ± 1.4277 | 0.813 ± 1.7505 | 1.083 ± 2.3145 | — |
| T. neutrophils; Week 252; n=31, 36, 45, 0 | 0.268 ± 1.4164 | 0.761 ± 1.5531 | 0.812 ± 1.3345 | — |
| T. neutrophils; Week 264; n=32, 38, 46, 0 | 0.475 ± 1.7483 | 0.761 ± 1.7316 | 1.176 ± 1.6844 | — |
| T. neutrophils; Week 276; n=31, 38, 45, 0 | 0.400 ± 1.6597 | 0.627 ± 1.8500 | 1.106 ± 1.3666 | — |
| T. neutrophils; Week 288; n=30, 38, 44, 0 | 0.456 ± 1.8521 | 0.673 ± 1.9230 | 0.913 ± 1.5880 | — |
| T. neutrophils; Week 300; n=30, 37, 43, 0 | 0.139 ± 1.2243 | 0.455 ± 1.4957 | 0.699 ± 1.1030 | — |
| T. neutrophils; Week 312; n=31, 33, 41, 0 | 0.243 ± 1.3595 | 0.417 ± 1.7807 | 0.564 ± 1.1666 | — |
| T. neutrophils; Week 324; n=3, 4, 2, 0 | 0.860 ± 2.7921 | 0.315 ± 1.0660 | 0.960 ± 0.4950 | — |
| Platelet count; Week 2; n=57, 56, 59, 59 | 11.0 ± 30.21 | 16.6 ± 27.48 | 14.3 ± 22.17 | 17.1 ± 33.56 |
| Platelet count; Week 4; n=57, 57, 59, 57 | 9.9 ± 27.70 | 20.1 ± 30.52 | 14.1 ± 21.35 | 15.6 ± 38.98 |
| Platelet count; Week 8; n=58, 56, 56, 55 | 10.3 ± 26.33 | 25.9 ± 33.21 | 18.4 ± 27.51 | 10.3 ± 36.86 |
| Platelet count; Week 12; n=58, 53, 57, 51 | 13.7 ± 28.85 | 14.6 ± 35.00 | 17.7 ± 33.02 | 11.2 ± 43.26 |
| Platelet count; Week 16; n=57, 54, 57, 52 | 16.5 ± 36.43 | 11.3 ± 30.85 | 17.9 ± 34.32 | 9.3 ± 40.36 |
| Platelet count; Week 20; n=56, 54, 55, 49 | 17.2 ± 32.75 | 14.5 ± 29.72 | 13.7 ± 32.98 | 17.1 ± 43.06 |
| Platelet count; Week 24; n=56, 53, 56, 47 | 12.0 ± 31.51 | 18.4 ± 34.30 | 19.3 ± 27.64 | 23.9 ± 49.14 |
| Platelet count; Week 26; n=48, 50, 53, 45 | 8.3 ± 32.59 | 11.2 ± 36.32 | 10.3 ± 30.94 | 17.5 ± 40.38 |
| Platelet count; Week 28; n=50, 52, 52, 45 | 6.6 ± 33.00 | 15.8 ± 34.97 | 17.8 ± 27.83 | 17.2 ± 44.39 |
| Platelet count; Week 32; n=51, 52, 55, 45 | 7.7 ± 41.79 | 11.6 ± 36.27 | 15.4 ± 27.19 | 13.8 ± 38.26 |
| Platelet count; Week 36; n=52, 53, 55, 44 | 5.2 ± 39.32 | 10.8 ± 39.28 | 11.8 ± 32.72 | 12.3 ± 43.83 |
| Platelet count; Week 40; n=51, 53, 54, 45 | 11.1 ± 44.07 | 8.9 ± 31.95 | 7.8 ± 31.86 | 18.9 ± 36.94 |
| Platelet count; Week 48; n=51, 52, 53, 44 | 12.5 ± 41.82 | 20.0 ± 38.20 | 17.6 ± 38.70 | 20.6 ± 42.78 |
| Platelet count; Week 60; n=48, 47, 51, 44 | 20.9 ± 39.25 | 18.7 ± 34.22 | 26.6 ± 37.23 | 30.8 ± 43.09 |
| Platelet count; Week 72; n=47, 48, 52, 42 | 23.7 ± 37.03 | 22.8 ± 32.35 | 22.7 ± 35.13 | 28.3 ± 37.19 |
| Platelet count; Week 84; n=46, 48, 51, 42 | 13.6 ± 42.78 | 17.2 ± 32.00 | 21.1 ± 38.36 | 18.9 ± 44.07 |
| Platelet count; Week 96; n=46, 45, 51, 41 | 25.9 ± 39.73 | 20.8 ± 39.00 | 21.7 ± 36.57 | 17.5 ± 40.11 |
| Platelet count; Week 108; n=43, 46, 49, 0 | 24.5 ± 44.43 | 24.6 ± 30.23 | 33.1 ± 46.23 | — |
| Platelet count; Week 120; n=41, 46, 49, 0 | 23.8 ± 48.05 | 26.9 ± 33.58 | 20.4 ± 31.47 | — |
| Platelet count; Week 132; n=40, 46, 48, 0 | 16.8 ± 33.67 | 21.0 ± 35.98 | 32.2 ± 35.34 | — |
| Platelet count; Week 144; n=37, 45, 44, 0 | 27.1 ± 50.68 | 23.2 ± 31.97 | 33.5 ± 54.61 | — |
| Platelet count; Week 156; n=37, 42, 47, 0 | 26.6 ± 53.14 | 30.6 ± 37.65 | 41.2 ± 47.37 | — |
| Platelet count; Week 168; n=35, 43, 46, 0 | 34.9 ± 43.78 | 36.4 ± 37.72 | 40.0 ± 50.19 | — |
| Platelet count; Week 180; n=36, 41, 46, 0 | 28.4 ± 48.03 | 27.6 ± 36.53 | 45.4 ± 54.46 | — |
| Platelet count; Week 192; n=35, 40, 46, 0 | 34.7 ± 58.72 | 24.6 ± 37.42 | 27.9 ± 45.02 | — |
| Platelet count; Week 204; n=34, 39, 45, 0 | 33.9 ± 59.13 | 26.4 ± 31.26 | 37.6 ± 45.21 | — |
| Platelet count; Week 216; n=32, 39, 44, 0 | 28.1 ± 48.97 | 25.2 ± 31.60 | 33.5 ± 44.09 | — |
| Platelet count; Week 228; n=31, 39, 46, 0 | 28.7 ± 49.38 | 27.1 ± 35.77 | 29.1 ± 41.22 | — |
| Platelet count; Week 240; n=32, 39, 47, 0 | 27.2 ± 52.69 | 26.2 ± 31.38 | 27.4 ± 42.22 | — |
| Platelet count; Week 252; n=31, 36, 44, 0 | 15.9 ± 48.02 | 15.4 ± 31.97 | 30.8 ± 39.37 | — |
| Platelet count; Week 264; n=32, 38, 45, 0 | 27.9 ± 48.97 | 23.2 ± 29.82 | 32.8 ± 43.26 | — |
| Platelet count; Week 276; n=31, 38, 45, 0 | 48.4 ± 55.68 | 34.5 ± 34.41 | 45.8 ± 41.35 | — |
| Platelet count; Week 288; n=30, 38, 43, 0 | 44.1 ± 60.21 | 35.5 ± 34.89 | 46.7 ± 43.13 | — |
| Platelet count; Week 300; n=30, 37, 40, 0 | 28.5 ± 55.51 | 26.8 ± 36.02 | 45.4 ± 39.15 | — |
| Platelet count; Week 312; n=31, 33, 41, 0 | 27.3 ± 52.62 | 30.9 ± 34.28 | 35.3 ± 37.26 | — |
| Platelet count; Week 324; n=3, 4, 2, 0 | 31.7 ± 17.47 | 8.3 ± 7.46 | 2.0 ± 9.90 | — |
| WBC count; Week 2; n=57, 56, 59, 59 | 0.19 ± 1.176 | 0.13 ± 1.506 | 0.31 ± 1.314 | 0.69 ± 1.606 |
| WBC count; Week 4; n=57, 57, 59, 57 | 0.16 ± 1.493 | 0.02 ± 1.435 | 0.30 ± 1.263 | 0.29 ± 1.753 |
| WBC count; Week 8; n=58, 56, 56, 55 | 0.37 ± 1.298 | 0.15 ± 1.595 | 0.48 ± 1.283 | 0.27 ± 1.123 |
| WBC; Week 12; n=58, 53, 57, 51 | 0.32 ± 1.427 | 0.28 ± 1.696 | 0.73 ± 1.375 | 0.54 ± 1.734 |
| WBC count; Week 16; n=57, 54, 57, 52 | 0.45 ± 1.806 | 0.02 ± 1.554 | 0.36 ± 1.080 | 0.36 ± 1.542 |
| WBC count; Week 20; n=56, 54, 55, 49 | 0.36 ± 1.510 | 0.23 ± 1.523 | 0.77 ± 1.848 | 0.78 ± 1.821 |
| WBC count; Week 24; n=56, 53, 56, 47 | 0.47 ± 1.245 | 0.34 ± 2.060 | 0.64 ± 1.226 | 0.55 ± 1.822 |
| WBC count; Week 26; n=48, 50, 53, 45 | 0.19 ± 1.130 | 0.26 ± 2.039 | 0.66 ± 1.257 | 0.35 ± 1.578 |
| WBC count; Week 28; n=50, 52, 52, 45 | 0.67 ± 1.412 | 0.42 ± 1.685 | 0.69 ± 1.428 | 0.39 ± 1.416 |
| WBC count; Week 32; n=51, 53, 55, 45 | 0.25 ± 1.598 | 0.45 ± 1.767 | 0.93 ± 1.704 | 0.71 ± 1.820 |
| WBC count; Week 36; n=52, 53, 55, 44 | 0.56 ± 1.532 | 0.30 ± 2.068 | 0.92 ± 1.178 | 0.36 ± 1.547 |
| WBC count; Week 40; n=51, 53, 55, 45 | 0.57 ± 1.668 | 0.42 ± 1.654 | 0.81 ± 1.205 | 0.75 ± 1.680 |
| WBC count; Week 48; n=51, 53, 54, 44 | 0.43 ± 1.499 | 0.53 ± 1.912 | 0.78 ± 1.447 | 0.73 ± 1.874 |
| WBC count; Week 60; n=48, 47, 52, 44 | 0.60 ± 1.774 | 0.76 ± 1.686 | 1.04 ± 1.160 | 0.95 ± 1.735 |
| WBC count; Week 72; n=47, 48, 52, 42 | 0.63 ± 1.932 | 0.56 ± 1.917 | 1.09 ± 1.378 | 1.02 ± 2.280 |
| WBC count; Week 84; n=46, 48, 51, 42 | 0.71 ± 1.805 | 0.96 ± 1.914 | 1.43 ± 1.622 | 0.95 ± 1.893 |
| WBC count; Week 96; n=46, 46, 52, 41 | 0.95 ± 1.687 | 1.01 ± 2.069 | 1.38 ± 1.405 | 0.92 ± 1.624 |
| WBC count; Week 108; n=43, 46, 49, 0 | 0.89 ± 2.190 | 0.90 ± 1.714 | 1.35 ± 1.749 | — |
| WBC count; Week 120; n=41, 46, 49, 0 | 0.59 ± 1.931 | 1.01 ± 1.988 | 1.16 ± 1.632 | — |
| WBC count; Week 132; n=40, 46, 49, 0 | 0.92 ± 2.274 | 0.71 ± 1.958 | 1.02 ± 1.103 | — |
| WBC count; Week 144; n=37, 45, 46, 0 | 0.91 ± 1.667 | 0.82 ± 1.727 | 1.22 ± 1.785 | — |
| WBC count; Week 156; n=37, 42, 49, 0 | 1.05 ± 2.056 | 0.75 ± 1.797 | 1.64 ± 1.291 | — |
| WBC count; Week 168; n=35, 43, 47, 0 | 0.97 ± 1.859 | 0.97 ± 1.748 | 1.58 ± 1.472 | — |
| WBC count; Week 180; n=36, 41, 47, 0 | 1.07 ± 1.778 | 0.69 ± 1.902 | 1.33 ± 1.485 | — |
| WBC count; Week 192; n=35, 40, 47, 0 | 0.61 ± 1.645 | 0.89 ± 1.972 | 1.11 ± 1.428 | — |
| WBC count; Week 204; n=34, 39, 47, 0 | 0.98 ± 2.042 | 0.95 ± 1.823 | 1.24 ± 1.554 | — |
| WBC count; Week 216; n=32, 39, 43, 0 | 0.88 ± 2.175 | 1.01 ± 1.859 | 1.37 ± 1.656 | — |
| WBC count; Week 228; n=31, 39, 47, 0 | 0.98 ± 1.970 | 1.13 ± 1.918 | 1.31 ± 1.329 | — |
| WBC count; Week 240; n=32, 39, 47, 0 | 0.79 ± 1.851 | 1.15 ± 1.942 | 1.53 ± 2.455 | — |
| WBC count; Week 252; n=31, 36, 45, 0 | 0.66 ± 1.649 | 1.10 ± 1.814 | 1.17 ± 1.531 | — |
| WBC count; Week 264; n=32, 38, 46, 0 | 0.62 ± 1.798 | 1.21 ± 1.985 | 1.66 ± 2.030 | — |
| WBC count; Week 276; n=31, 38, 45, 0 | 0.92 ± 1.985 | 1.04 ± 2.056 | 1.57 ± 1.721 | — |
| WBC count; Week 288; n=30, 38, 44, 0 | 0.92 ± 2.188 | 1.13 ± 2.293 | 1.32 ± 1.908 | — |
| WBC count; Week 300; n=30, 37, 43, 0 | 0.58 ± 1.762 | 0.77 ± 1.856 | 1.02 ± 1.321 | — |
| WBC count; Week 312; n=31, 33, 41, 0 | 0.57 ± 1.732 | 0.70 ± 2.051 | 0.95 ± 1.274 | — |
| WBC count; Week 324; n=3, 4, 2, 0 | 1.97 ± 3.075 | 0.53 ± 0.984 | -0.05 ± 1.626 | — |
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.
| Percentage of participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events | 7 | 7 | 7 | 15 |
Twelve lead ECG was performed after the participants had rested in a semi-supine position for at least 5 minutes using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst case results at any time on-treatment is presented.
| Participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 25 | 19 | 15 | 10 |
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia.
| Participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Any AE | 54 | 54 | 55 | 59 |
| Any SAE | 2 | 0 | 2 | 2 |
Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, chloride, cholesterol, CK, creatinine, glucose, high density lipoprotein (HDL) cholesterol, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin, triglycerides and urea/blood urea nitrogen (BUN). A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
| Participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| ALT; Grade 1 | 3 | 4 | 13 | 8 |
| ALT; Grade 2 | 1 | 5 | 0 | 4 |
| ALT; Grade 3 | 0 | 0 | 0 | 0 |
| ALT; Grade 4 | 0 | 0 | 2 | 0 |
| Albumin; Grade 1 | 0 | 0 | 0 | 0 |
| Albumin; Grade 2 | 0 | 0 | 0 | 0 |
| Albumin; Grade 3 | 0 | 0 | 0 | 0 |
| Albumin; Grade 4 | 0 | 0 | 0 | 0 |
| ALP; Grade 1 | 0 | 1 | 4 | 3 |
| ALP; Grade 2 | 0 | 1 | 0 | 0 |
| ALP; Grade 3 | 0 | 0 | 0 | 0 |
| ALP; Grade 4 | 0 | 0 | 0 | 0 |
| AST; Grade 1 | 6 | 8 | 7 | 6 |
| AST; Grade 2 | 2 | 5 | 1 | 1 |
| AST; Grade 3 | 1 | 0 | 3 | 2 |
| AST; Grade 4 | 0 | 0 | 0 | 0 |
| CO2/bicarbonate; Grade 1 | 1 | 5 | 1 | 6 |
| CO2/bicarbonate; Grade 2 | 0 | 0 | 0 | 0 |
| CO2/bicarbonate; Grade 3 | 0 | 0 | 0 | 0 |
| CO2/bicarbonate; Grade 4 | 0 | 0 | 0 | 0 |
| Chloride; Grade 1 | 0 | 0 | 0 | 0 |
| Chloride; Grade 2 | 0 | 0 | 0 | 0 |
| Chloride; Grade 3 | 0 | 0 | 0 | 0 |
| Chloride; Grade 4 | 0 | 0 | 0 | 0 |
| Cholesterol; Grade 1 | 7 | 8 | 12 | 4 |
| Cholesterol; Grade 2 | 3 | 2 | 3 | 9 |
| Cholesterol; Grade 3 | 0 | 0 | 2 | 6 |
| Cholesterol; Grade 4 | 0 | 0 | 0 | 0 |
| CK; Grade 1 | 7 | 5 | 6 | 4 |
| CK; Grade 2 | 2 | 2 | 3 | 1 |
| CK; Grade 3 | 3 | 1 | 1 | 2 |
| CK; Grade 4 | 2 | 4 | 2 | 4 |
| Creatinine; Grade 1 | 0 | 0 | 0 | 1 |
| Creatinine; Grade 2 | 1 | 0 | 0 | 1 |
| Creatinine; Grade 3 | 0 | 0 | 0 | 0 |
| Creatinine; Grade 4 | 0 | 0 | 0 | 0 |
| Glucose; Grade 1 | 10 | 8 | 13 | 6 |
| Glucose; Grade 2 | 5 | 3 | 1 | 5 |
| Glucose; Grade 3 | 0 | 0 | 2 | 0 |
| Glucose; Grade 4 | 0 | 0 | 0 | 1 |
| HDL cholesterol; Grade 1 | 0 | 0 | 0 | 0 |
| HDL cholesterol; Grade 2 | 0 | 0 | 0 | 0 |
| HDL cholesterol; Grade 3 | 0 | 0 | 0 | 0 |
| HDL cholesterol; Grade 4 | 0 | 0 | 0 | 0 |
| LDL cholesterol; Grade 1 | 5 | 9 | 8 | 4 |
| LDL cholesterol; Grade 2 | 4 | 1 | 5 | 8 |
| LDL cholesterol; Grade 3 | 0 | 0 | 3 | 2 |
| LDL cholesterol; Grade 4 | 0 | 0 | 0 | 0 |
| Lipase; Grade 1 | 9 | 3 | 5 | 6 |
| Lipase; Grade 2 | 6 | 1 | 7 | 5 |
| Lipase; Grade 3 | 2 | 1 | 4 | 1 |
| Lipase; Grade 4 | 0 | 0 | 1 | 0 |
| Inorganic phosphorus; Grade 1 | 5 | 2 | 7 | 6 |
| Inorganic phosphorus; Grade 2 | 6 | 2 | 2 | 8 |
| Inorganic phosphorus; Grade 3 | 1 | 1 | 2 | 2 |
| Inorganic phosphorus; Grade 4 | 0 | 0 | 0 | 0 |
| Potassium; Grade 1 | 7 | 1 | 2 | 2 |
| Potassium; Grade 2 | 0 | 0 | 0 | 1 |
| Potassium; Grade 3 | 0 | 0 | 0 | 0 |
| Potassium; Grade 4 | 0 | 0 | 0 | 0 |
| Sodium; Grade 1 | 7 | 4 | 7 | 8 |
| Sodium; Grade 2 | 0 | 0 | 0 | 1 |
| Sodium; Grade 3 | 0 | 0 | 0 | 0 |
| Sodium; Grade 4 | 0 | 0 | 0 | 0 |
| Total bilirubin; Grade 1 | 0 | 1 | 4 | 0 |
| Total bilirubin; Grade 2 | 2 | 1 | 1 | 0 |
| Total bilirubin; Grade 3 | 0 | 0 | 0 | 0 |
| Total bilirubin; Grade 4 | 0 | 0 | 0 | 0 |
| Triglycerides; Grade 1 | 0 | 0 | 0 | 0 |
| Triglycerides; Grade 2 | 0 | 1 | 3 | 2 |
| Triglycerides; Grade 3 | 0 | 0 | 1 | 0 |
| Triglycerides; Grade 4 | 0 | 0 | 0 | 1 |
| Urea/BUN; Grade 1 | 0 | 0 | 0 | 0 |
| Urea/BUN; Grade 2 | 0 | 0 | 0 | 0 |
| Urea/BUN; Grade 3 | 0 | 0 | 0 | 0 |
| Urea/BUN; Grade 4 | 0 | 0 | 0 | 0 |
Blood samples were collected for the analysis of following hematology parameters: APTT, basophils, eosinophils, hematocrit, hemoglobin, INR, lymphocytes, mean corpuscle volume (MCV), monocytes, platelet count, PT, red blood cell (RBC) count, total neutrophils and WBC count. A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.
| Participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| APTT; Grade 1 | 1 | 0 | 1 | 3 |
| APTT; Grade 2 | 0 | 0 | 0 | 0 |
| APTT; Grade 3 | 0 | 0 | 0 | 0 |
| APTT; Grade 4 | 0 | 1 | 1 | 0 |
| Basophils; Grade 1 | 0 | 0 | 0 | 0 |
| Basophils; Grade 2 | 0 | 0 | 0 | 0 |
| Basophils; Grade 3 | 0 | 0 | 0 | 0 |
| Basophils; Grade 4 | 0 | 0 | 0 | 0 |
| Eosinophils; Grade 1 | 0 | 0 | 0 | 0 |
| Eosinophils; Grade 2 | 0 | 0 | 0 | 0 |
| Eosinophils; Grade 3 | 0 | 0 | 0 | 0 |
| Eosinophils; Grade 4 | 0 | 0 | 0 | 0 |
| Hematocrit; Grade 1 | 0 | 0 | 0 | 0 |
| Hematocrit; Grade 2 | 0 | 0 | 0 | 0 |
| Hematocrit; Grade 3 | 0 | 0 | 0 | 0 |
| Hematocrit; Grade 4 | 0 | 0 | 0 | 0 |
| Hemoglobin; Grade 1 | 0 | 0 | 0 | 0 |
| Hemoglobin; Grade 2 | 1 | 0 | 0 | 0 |
| Hemoglobin; Grade 3 | 0 | 0 | 0 | 0 |
| Hemoglobin; Grade 4 | 0 | 0 | 0 | 0 |
| INR; Grade 1 | 0 | 2 | 0 | 1 |
| INR; Grade 2 | 0 | 0 | 0 | 0 |
| INR; Grade 3 | 0 | 0 | 0 | 0 |
| INR; Grade 4 | 0 | 1 | 0 | 0 |
| Lymphocytes; Grade 1 | 0 | 0 | 0 | 0 |
| Lymphocytes; Grade 2 | 0 | 0 | 0 | 0 |
| Lymphocytes; Grade 3 | 0 | 0 | 0 | 0 |
| Lymphocytes; Grade 4 | 0 | 0 | 0 | 0 |
| MCV; Grade 1 | 0 | 0 | 0 | 0 |
| MCV; Grade 2 | 0 | 0 | 0 | 0 |
| MCV; Grade 3 | 0 | 0 | 0 | 0 |
| MCV; Grade 4 | 0 | 0 | 0 | 0 |
| Monocytes; Grade 1 | 0 | 0 | 0 | 0 |
| Monocytes; Grade 2 | 0 | 0 | 0 | 0 |
| Monocytes; Grade 3 | 0 | 0 | 0 | 0 |
| Monocytes; Grade 4 | 0 | 0 | 0 | 0 |
| Platelet count; Grade 1 | 2 | 0 | 2 | 1 |
| Platelet count; Grade 2 | 0 | 0 | 0 | 0 |
| Platelet count; Grade 3 | 0 | 0 | 0 | 0 |
| Platelet count; Grade 4 | 0 | 0 | 0 | 0 |
| PT; Grade 1 | 0 | 1 | 0 | 1 |
| PT; Grade 2 | 0 | 0 | 0 | 0 |
| PT; Grade 3 | 0 | 0 | 0 | 0 |
| PT; Grade 4 | 0 | 1 | 0 | 0 |
| RBC; Grade 1 | 0 | 0 | 0 | 0 |
| RBC; Grade 2 | 0 | 0 | 0 | 0 |
| RBC; Grade 3 | 0 | 0 | 0 | 0 |
| RBC; Grade 4 | 0 | 0 | 0 | 0 |
| Total neutrophils; Grade 1 | 8 | 6 | 8 | 2 |
| Total neutrophils; Grade 2 | 3 | 2 | 3 | 2 |
| Total neutrophils; Grade 3 | 0 | 0 | 0 | 1 |
| Total neutrophils; Grade 4 | 0 | 0 | 1 | 1 |
| WBC count; Grade 1 | 0 | 2 | 2 | 1 |
| WBC count; Grade 2 | 0 | 1 | 0 | 0 |
| WBC count; Grade 3 | 0 | 0 | 0 | 0 |
| WBC count; Grade 4 | 0 | 0 | 0 | 0 |
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.
| Percentage of participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase | 0 | 2 | 5 | 13 |
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.
| Percentage of participants | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg |
|---|---|---|---|---|
| Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase | 2 | 4 | 2 | 2 |
Blood samples for pharmacokinetic (PK) analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. The PK Summary Population comprised of all participants who received GSK1265744 or with Rilpivirine, underwent intensive and/or limited/sparse PK sampling during the study, and provided evaluable GSK1265744 and Rilpivirine plasma concentration data
| Hours*micrograms per milliliter | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg |
|---|---|---|---|
| Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2 | 45.69 ± 32 | 133.74 ± 32 | 227.58 ± 57 |
Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
| Micrograms per milliliter | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg |
|---|---|---|---|
| Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2 | 2.77 ± 33 | 7.49 ± 28 | 13.12 ± 44 |
Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.
| Micrograms per milliliter | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg |
|---|---|---|---|
| Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2 | 1.45 ± 37 | 4.34 ± 38 | 5.83 ± 61 |
Data was not collected for analysis of rilpivirine PK parameters.
No measurements were reported for this outcome.
Data was not collected for analysis of rilpivirine PK parameters.
No measurements were reported for this outcome.
Data was not collected for analysis of rilpivirine PK parameters.
No measurements were reported for this outcome.
Collected over Non-SAEs and SAEs were collected from start of study treatment (Day 1) to Week 24 for induction phase; Week 24 to Week 96 for Maintenance Phase and from Week 96 to Week 324 for Open-label phase.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GSK1265744 10 mg (Induction Phase) | 0/60 (0%) | 2/60 (3.3%) | 46/60 (76.7%) |
| GSK1265744 30 mg (Induction Phase) | 0/60 (0%) | 0/60 (0%) | 47/60 (78.3%) |
| GSK1265744 60 mg (Induction Phase) | 0/61 (0%) | 2/61 (3.3%) | 50/61 (82%) |
| Efavirenz 600 mg (Induction Phase) | 0/62 (0%) | 2/62 (3.2%) | 54/62 (87.1%) |
| GSK1265744 10 mg (Maintenance Phase) | 0/52 (0%) | 5/52 (9.6%) | 35/52 (67.3%) |
| GSK1265744 30 mg (Maintenance Phase) | 0/53 (0%) | 5/53 (9.4%) | 44/53 (83%) |
| GSK1265744 60 mg (Maintenance Phase) | 0/55 (0%) | 5/55 (9.1%) | 47/55 (85.5%) |
| Efavirenz 600 mg (Maintenance Phase) | 0/47 (0%) | 2/47 (4.3%) | 33/47 (70.2%) |
| GSK1265744 10 mg (Open-label Phase) | 0/46 (0%) | 7/46 (15.2%) | 32/46 (69.6%) |
| GSK1265744 30 mg (Open-label Phase) | 1/47 (2.1%) | 8/47 (17%) | 38/47 (80.9%) |
| GSK1265744 60 mg (Open-label Phase) | 1/51 (2%) | 5/51 (9.8%) | 40/51 (78.4%) |
| Efavirenz 600mg (Open-label Phase) | — | — | — |
| Event | GSK1265744 10 mg (Induction Phase) | GSK1265744 30 mg (Induction Phase) | GSK1265744 60 mg (Induction Phase) | Efavirenz 600 mg (Induction Phase) | GSK1265744 10 mg (Maintenance Phase) | GSK1265744 30 mg (Maintenance Phase) | GSK1265744 60 mg (Maintenance Phase) | Efavirenz 600 mg (Maintenance Phase) | GSK1265744 10 mg (Open-label Phase) | GSK1265744 30 mg (Open-label Phase) | GSK1265744 60 mg (Open-label Phase) | Efavirenz 600mg (Open-label Phase) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Major depressionPsychiatric disorders | 0/60 | 0/60 | 0/61 | 0/62 | 0/52 | 0/53 | 0/55 | 0/47 | 2/46 | 0/47 | 0/51 | — |
| Suicide attemptPsychiatric disorders | 0/60 | 0/60 | 0/61 | 1/62 | 0/52 | 0/53 | 0/55 | 0/47 | 2/46 | 1/47 | 0/51 | — |
| Systemic inflammatory response syndromeGeneral disorders | 0/60 | 0/60 | 0/61 | 0/62 | 0/52 | 0/53 | 0/55 | 0/47 | 0/46 | 2/47 | 0/51 | — |
| Anorectal infectionInfections and infestations | 0/60 | 0/60 | 0/61 | 0/62 | 0/52 | 0/53 | 0/55 | 0/47 | 1/46 | 0/47 | 0/51 | — |
| PneumoniaInfections and infestations | 0/60 | 0/60 | 0/61 | 0/62 | 1/52 | 1/53 | 0/55 | 0/47 | 1/46 | 0/47 | 0/51 | — |
| Humerus fractureInjury, poisoning and procedural complications | 0/60 | 0/60 | 0/61 | 0/62 | 0/52 | 0/53 | 0/55 | 0/47 | 1/46 | 0/47 | 0/51 | — |
| Liver function test increasedInvestigations | 0/60 | 0/60 | 0/61 | 0/62 | 0/52 | 0/53 | 0/55 | 0/47 | 1/46 | 0/47 | 0/51 | — |
| Atrial thrombosisCardiac disorders | 0/60 | 0/60 | 0/61 | 0/62 | 0/52 | 0/53 | 0/55 | 0/47 | 0/46 | 1/47 | 0/51 | — |
| Abdominal discomfortGastrointestinal disorders | 0/60 | 0/60 | 0/61 | 0/62 | 0/52 | 0/53 | 0/55 | 0/47 | 0/46 | 1/47 | 0/51 | — |
| Anal fistulaGastrointestinal disorders | 0/60 | 0/60 | 0/61 | 0/62 | 0/52 | 0/53 | 0/55 | 0/47 | 0/46 | 1/47 | 0/51 | — |
| Event | GSK1265744 10 mg (Induction Phase) | GSK1265744 30 mg (Induction Phase) | GSK1265744 60 mg (Induction Phase) | Efavirenz 600 mg (Induction Phase) | GSK1265744 10 mg (Maintenance Phase) | GSK1265744 30 mg (Maintenance Phase) | GSK1265744 60 mg (Maintenance Phase) | Efavirenz 600 mg (Maintenance Phase) | GSK1265744 10 mg (Open-label Phase) | GSK1265744 30 mg (Open-label Phase) | GSK1265744 60 mg (Open-label Phase) | Efavirenz 600mg (Open-label Phase) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 3/60 | 8/60 | 9/61 | 9/62 | 9/52 | 14/53 | 12/55 | 5/47 | 3/46 | 15/47 | 14/51 | — |
| DizzinessNervous system disorders | 5/60 | 5/60 | 2/61 | 18/62 | 2/52 | 2/53 | 1/55 | 0/47 | 0/46 | 2/47 | 0/51 | — |
| Abnormal dreamsPsychiatric disorders | 1/60 | 5/60 | 3/61 | 15/62 | 1/52 | 0/53 | 3/55 | 0/47 | 0/46 | 0/47 | 0/51 | — |
| NauseaGastrointestinal disorders | 14/60 | 11/60 | 11/61 | 13/62 | 0/52 | 3/53 | 8/55 | 2/47 | 1/46 | 5/47 | 1/51 | — |
| InsomniaPsychiatric disorders | 2/60 | 6/60 | 7/61 | 14/62 | 3/52 | 2/53 | 4/55 | 3/47 | 3/46 | 1/47 | 4/51 | — |
| HeadacheNervous system disorders | 13/60 | 13/60 | 13/61 | 7/62 | 2/52 | 3/53 | 2/55 | 0/47 | 4/46 | 3/47 | 2/51 | — |
| DiarrhoeaGastrointestinal disorders | 10/60 | 7/60 | 11/61 | 8/62 | 5/52 | 7/53 | 5/55 | 5/47 | 6/46 | 5/47 | 5/51 | — |
| FatigueGeneral disorders | 6/60 | 5/60 | 7/61 | 10/62 | 4/52 | 5/53 | 3/55 | 3/47 | 3/46 | 5/47 | 3/51 | — |
| NasopharyngitisInfections and infestations | 9/60 | 2/60 | 8/61 | 3/62 | 2/52 | 4/53 | 2/55 | 5/47 | 5/46 | 5/47 | 3/51 | — |
| RashSkin and subcutaneous tissue disorders | 3/60 | 2/60 | 3/61 | 8/62 | 1/52 | 6/53 | 2/55 | 0/47 | 1/46 | 2/47 | 3/51 | — |
| Age, Continuous(Years) | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg | Total |
|---|---|---|---|---|---|
| Mean | 34.0 ± 9.91 | 34.4 ± 10.24 | 36.2 ± 10.15 | 35.6 ± 12.30 | 35.1 ± 10.68 |
| Sex: Female, Male(Participants) | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg | Total |
|---|---|---|---|---|---|
| Female | 3 | 2 | 4 | 1 | 10 |
| Male | 57 | 58 | 57 | 61 | 233 |
| Race/Ethnicity, Customized(Participants) | GSK1265744 10 mg | GSK1265744 30 mg | GSK1265744 60 mg | Efavirenz 600 mg | Total |
|---|---|---|---|---|---|
| African American (Af Am)/African Heritage (Her) | 21 | 17 | 18 | 20 | 76 |
| American Indian or Alaskan Native (Nat) | 0 | 0 | 2 | 2 | 4 |
| Asian-Central/South Asian Her | 1 | 1 | 1 | 0 | 3 |
| Asian-Japanese/East Asian/South East Asian Her | 0 | 1 | 2 | 0 | 3 |
| White | 37 | 39 | 36 | 39 | 151 |
| Af Am/Af Her and Asian and White | 0 | 0 | 1 | 0 | 1 |
| Af Am/Af Her & Nat Hawaiian/other Pacific islander | 0 | 0 | 1 | 0 | 1 |
| Af Am/Af Her & White | 0 | 2 | 0 | 0 | 2 |
| American Indian or Alaskan Native & White | 1 | 0 | 0 | 0 | 1 |
| Asian & White | 0 | 0 | 0 | 1 | 1 |
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ViiV Healthcare