CClinicalTrials.gg
Sign In
CompletedNCT00435929Updated Mar 29, 2018Results posted

A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.

A Phase 1 interventional study of Ritonavir and saquinavir [Invirase] in HIV Infections, sponsored by Hoffmann-La Roche. Completed at 8 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-29.

Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This 2 arm study will assess the effect of moderate liver impairment on the pharmacokinetics of saquinavir and ritonavir at steady state following administration of saquinavir/ritonavir 1000mg/100mg po bid in HIV patients. Saquinavir/ritonavir will be administered concomitantly with 2 to 3 active nucleoside reverse transcriptase inhibitors. The study will compare a group of HIV patients without known liver disease and a group with moderate liver disease. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.

02

Conditions studied

  • HIV Infections

Keywords

  • Treatment Naive
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 16 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • adult patients, 18-65 years of age;
  • HIV infection;
  • normal liver function, or moderate liver disease (Child-Pugh grade B);
  • antiretroviral therapy naive and eligible to take antiretroviral treatment as per treatment guidelines, or treatment experienced for at least 4 weeks prior to first dosing.

Exclusion criteria

Exclusion Criteria:

  • severe ascites at screening, or Child-Pugh grade C;
  • acute infection or current malignancy requiring treatment;
  • taking any inhibitor of CYP3A4 (with the exception of anti-HIV drugs) within 14 days prior to first dosing;
  • taking any inducer of CYP3A4 (with the exception of anti-HIV drugs) within 4 weeks prior to pharmacokinetic evaluation (day 14 or 28);
  • evidence of resistance to saquinavir.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    1

    Drug: Ritonavir · Drug: saquinavir [Invirase]

  • Experimental
    2

    Drug: Ritonavir · Drug: saquinavir [Invirase]

Interventions

  • DrugRitonavir

    100mg po bid

  • Drugsaquinavir [Invirase]

    1000mg po bid

06

What researchers measure

Primary outcomes

  1. Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours After Dosing (AUC 0-12h) of Saquinavir (SQV) and Ritonavir (RTV)

    Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the area under the plasma concentration-time curve from 0 to 12 hours after dosing (AUC (0-12h) of SQV and RTV The AUC (0-12hours) was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.

    Time frame: Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14

  2. Maximum Observed Plasma Concentration (Cmax) of SQV and RTV

    The plasma concentration (Cmax) is defined as maximum observed analyte concentration. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the maximum observed plasma concentration (C max) of SQV and Ritonavir RTV The Cmax was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.

    Time frame: Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14

Secondary outcomes

  1. Time of Maximum Plasma Concentration (Tmax) of SQV and RTV

    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the time of maximum plasma concentration of SQV and RTV. The Tmax was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.

    Time frame: Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14

  2. Terminal Half-life (T1/2) of SQV and RTV

    Terminal half-life is the time measured for the plasma concentration to decrease by one half. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the terminal half-life (T1/2) of SQV and RTV. The T1/2 was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.

    Time frame: Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14

  3. Minimum Observed Plasma Concentration (Cmin) of SQV and RTV

    Cmin is the minimum blood plasma concentration that a drug achieves. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the minimum observed plasma concentration (C min) of SQV and RTV The Cmin was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.

    Time frame: Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14

  4. Plasma Clearance After Oral Administration (CL/F) of SQV and RTV

    The CL/F is the oral clearance; that is clearance based on oral bioavailability. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the plasma clearance after oral administration (CL/F)of SQV and RTV The CL/F was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.

    Time frame: Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14

  5. Volume of Distribution (Vd) of SQV and RTV

    Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the Vd of SQV and RTV The Vd was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.

    Time frame: Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14

  6. Cluster of Differentiation 4 (CD4 ) Count

    The pharmacodynamic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the cluster of differentiation 4 (CD4) count in participants in each group.

    Time frame: Screening (Day -35 to -1), pre-dose on Day 8, Day 14 and at follow up (Day 28-Day 35)

  7. Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Parameters

    Laboratory parameters specified in Clinical Operating Guidelines (COG) were summarized. AIDS Clinical Trial Group (ACTG) and American Heart Association (AHA) criteria were used to grade COG laboratory test values. Laboratory parameters for which an increase to Grade 3 (G3) or Grade 4 (G4) occurred are presented in the table below.

    Time frame: Up to Day 35

  8. Number Participants With Abnormal Vital Signs

    Abnormal Vital signs included are high and low Pulse rate (PR), high and how Temperature (Temp), high and low Systolic Blood Pressure (SBP) and high and low Diastolic Blood Pressure (DBP). Vital signs (SBP, DBP, PR,Temp) were measured after participants were in a semi-supine position for at least 5 minutes.

    Time frame: Up to Day 35

  9. Number of Participants With Abnormal Electrocardiogram (ECG) Findings

    Abnormal ECG findings included are high and low Heart Rate (HRT), high and low PQ/PR interval (PQ/PR), high and low QRS interval (QRS), high and low QT interval (QT), high and low QTCB interval (QTcB), high and low QTcF interval (QTcF), high and low RR interval (RR), high and low T Wave, high and low U Wave, high and low ECG. The 12 Lead ECG was recorded after participants were in a semi-supine position for at least 5 minutes. Only participants with abnormal ECG findings are presented in the table below.

    Time frame: Up to Day 35

07

Results

Posted Jan 8, 2016

Participant flow

The study was conducted from 12 September 2006 to 09 April 2009 at 3 sites in US and 2 in Canada.

Participant flow — Overall Study
MilestoneNormal Liver FunctionModerate Hepatic Impairment
Started79
Completed79
Not completed00

Outcome measures

PrimaryArea Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours After Dosing (AUC 0-12h) of Saquinavir (SQV) and Ritonavir (RTV)

Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the area under the plasma concentration-time curve from 0 to 12 hours after dosing (AUC (0-12h) of SQV and RTV The AUC (0-12hours) was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.

Time frame:
Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14
Reported as:
Mean · ng*hr/mL
Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 Hours After Dosing (AUC 0-12h) of Saquinavir (SQV) and Ritonavir (RTV)
ng*hr/mLNormal Liver FunctionModerate Hepatic Impairment
AUC for SQV28518 ± 2015724332 ± 24700
AUC for RTV10985 ± 17239930 ± 5243
Statistical analysis
  • Normal Liver Function vs Moderate Hepatic Impairment · Geometric mean ratio: 0.656 · 90% CI 0.268 to 1.603
  • Normal Liver Function vs Moderate Hepatic Impairment · Geometric mean ratio: 0.764 · 90% CI 0.505 to 1.156
PrimaryMaximum Observed Plasma Concentration (Cmax) of SQV and RTV

The plasma concentration (Cmax) is defined as maximum observed analyte concentration. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the maximum observed plasma concentration (C max) of SQV and Ritonavir RTV The Cmax was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.

Time frame:
Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14
Reported as:
Mean · ng/mL
Maximum Observed Plasma Concentration (Cmax) of SQV and RTV
ng/mLNormal Liver FunctionModerate Hepatic Impairment
Cmax of SQV4300 ± 29403610 ± 3000
Cmax of RTV1500 ± 2941460 ± 690
Statistical analysis
  • Normal Liver Function vs Moderate Hepatic Impairment · Geometric mean ratio: 0.716 · 90% CI 0.311 to 1.644
  • Normal Liver Function vs Moderate Hepatic Impairment · Geometric mean ratio: 0.844 · 90% CI 0.551 to 1.292
SecondaryTime of Maximum Plasma Concentration (Tmax) of SQV and RTV

The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the time of maximum plasma concentration of SQV and RTV. The Tmax was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.

Time frame:
Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14
Reported as:
Mean · hour
Time of Maximum Plasma Concentration (Tmax) of SQV and RTV
hourNormal Liver FunctionModerate Hepatic Impairment
Tmax of SQV5.00 ± 1.835.00 ± 2.38
Tmax of RTV4.29 ± 1.504.07 ± 1.75
SecondaryTerminal Half-life (T1/2) of SQV and RTV

Terminal half-life is the time measured for the plasma concentration to decrease by one half. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the terminal half-life (T1/2) of SQV and RTV. The T1/2 was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.

Time frame:
Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post-dose on Day 14
Reported as:
Mean · hour
Terminal Half-life (T1/2) of SQV and RTV
hourNormal Liver FunctionModerate Hepatic Impairment
T1/2 of SQV3.31 ± 0.8234.10 ± 1.90
T1/2 of RTV3.80 ± 0.9084.82 ± 2.82
SecondaryMinimum Observed Plasma Concentration (Cmin) of SQV and RTV

Cmin is the minimum blood plasma concentration that a drug achieves. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the minimum observed plasma concentration (C min) of SQV and RTV The Cmin was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.

Time frame:
Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14
Reported as:
Mean · ng/mL
Minimum Observed Plasma Concentration (Cmin) of SQV and RTV
ng/mLNormal Liver FunctionModerate Hepatic Impairment
Cmin of SQV965 ± 920834 ± 870
Cmin of RTV399 ± 172418 ± 300
SecondaryPlasma Clearance After Oral Administration (CL/F) of SQV and RTV

The CL/F is the oral clearance; that is clearance based on oral bioavailability. The Pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the plasma clearance after oral administration (CL/F)of SQV and RTV The CL/F was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.

Time frame:
Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14
Reported as:
Mean · L/hr
Plasma Clearance After Oral Administration (CL/F) of SQV and RTV
L/hrNormal Liver FunctionModerate Hepatic Impairment
CL/F of SQV47.052 ± 20.25484.416 ± 68.645
CL/F of RTV9.289 ± 1.39212.568 ± 5.885
SecondaryVolume of Distribution (Vd) of SQV and RTV

Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. The pharmacokinetic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the Vd of SQV and RTV The Vd was analyzed for SQV and RTV by non-compartmental methods, using WinNonlin.

Time frame:
Pre-dose and at 0.5 hr, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10hrs, and 12 hrs post dose on Day 14
Reported as:
Mean · Litres
Volume of Distribution (Vd) of SQV and RTV
LitresNormal Liver FunctionModerate Hepatic Impairment
Vd of SQV213.294 ± 95.048464.049 ± 334.460
Vd of RTV50.232 ± 11.888102.585 ± 112.579
SecondaryCluster of Differentiation 4 (CD4 ) Count

The pharmacodynamic profile for following 14 days of administration with SQV/RTV 1000/100 mg BID included determining the cluster of differentiation 4 (CD4) count in participants in each group.

Time frame:
Screening (Day -35 to -1), pre-dose on Day 8, Day 14 and at follow up (Day 28-Day 35)
Reported as:
Mean · cells/cubic millimeter
Cluster of Differentiation 4 (CD4 ) Count
cells/cubic millimeterNormal Liver FunctionModerate Hepatic Impairment
Screening; n=7, 9540.000 ± 218.187451.444 ± 249.011
Day 8;n=6, 9638.500 ± 254.358558.000 ± 243.994
Day 14;n=7, 9683.571 ± 250.160566.333 ± 257.484
Follow up; n=6, 8692.500 ± 150.045567.625 ± 261.947
SecondaryNumber of Participants With the Indicated Grade 3 and Grade 4 Laboratory Parameters

Laboratory parameters specified in Clinical Operating Guidelines (COG) were summarized. AIDS Clinical Trial Group (ACTG) and American Heart Association (AHA) criteria were used to grade COG laboratory test values. Laboratory parameters for which an increase to Grade 3 (G3) or Grade 4 (G4) occurred are presented in the table below.

Time frame:
Up to Day 35
Reported as:
Number · participants
Number of Participants With the Indicated Grade 3 and Grade 4 Laboratory Parameters
participantsNormal Liver FunctionModerate Hepatic Impairment
ASAT (SGOT), (Hyper) G301
ASAT (SGOT), (Hyper) G400
Alkaline Phosphatase, (Hyper) G300
Alkaline Phosphatase, (Hyper) G400
ALAT (SGPT), (Hyper) G300
ALAT (SGPT), (Hyper) G400
Direct Bilirubin, (Hyper) G301
Direct Bilirubin, (Hyper) G401
Creatinine, (Hyper) G300
Creatinine, (Hyper) G400
Albumin, (Hypo) G300
Albumin, (Hypo) G400
Prothrombin Time seconds(Hyper) G301
Prothrombin Time seconds (Hyper) G400
Creatine Kinase, (Hyper) G301
Creatine Kinase, (Hyper) G400
Cholesterol, (Hyper) G300
Cholesterol, (Hyper) G400
Triglycerides, (Hyper) G320
Triglycerides, (Hyper) G400
Calcium, (Hypo) G300
Calcium, (Hypo) G400
Potassium, (Hypo) G300
Potassium, (Hypo) G400
Sodium, (Hypo) G300
Sodium, (Hypo) G400
Platelets, (Hypo) G300
Platelets, (Hypo) G400
Neutrophils, (Hypo) G301
Neutrophils, (Hypo) G400
Fasting Glucose, (Hyper) G300
Fasting Glucose, (Hyper) G400
Amylase, (Hyper) G301
Amylase, (Hyper) G400
Uric Acid, (Hyper) G302
Uric Acid, (Hyper) G400
Proteinuria 0 to 4+, (Hyper) G301
Proteinuria 0 to 4+, (Hyper) G400
SecondaryNumber Participants With Abnormal Vital Signs

Abnormal Vital signs included are high and low Pulse rate (PR), high and how Temperature (Temp), high and low Systolic Blood Pressure (SBP) and high and low Diastolic Blood Pressure (DBP). Vital signs (SBP, DBP, PR,Temp) were measured after participants were in a semi-supine position for at least 5 minutes.

Time frame:
Up to Day 35
Reported as:
Number · participants
Number Participants With Abnormal Vital Signs
participantsNormal Liver FunctionModerate Hepatic Impairment
High PR00
Low PR00
High Temp00
Low Temp00
High-SBP11
Low-SBP00
High-DBP00
Low-DBP12
SecondaryNumber of Participants With Abnormal Electrocardiogram (ECG) Findings

Abnormal ECG findings included are high and low Heart Rate (HRT), high and low PQ/PR interval (PQ/PR), high and low QRS interval (QRS), high and low QT interval (QT), high and low QTCB interval (QTcB), high and low QTcF interval (QTcF), high and low RR interval (RR), high and low T Wave, high and low U Wave, high and low ECG. The 12 Lead ECG was recorded after participants were in a semi-supine position for at least 5 minutes. Only participants with abnormal ECG findings are presented in the table below.

Time frame:
Up to Day 35
Reported as:
Number · participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
participantsNormal Liver FunctionModerate Hepatic Impairment
HIGH- HRT ECG ; n=7, 910
LOW- HRT ECG; n=7, 900
HIGH- PQ (PR); n=7, 901
LOW- PQ (PR); n=7, 900
HIGH- QRS; n=7, 900
LOW- QRS; n=7, 900
HIGH- QT; n=7, 902
LOW- QT; n=7, 900
HIGH- QTcB; n=5, 802
LOW- QTcB; n=5, 800
HIGH- QTcF; n=5, 802
LOW- QTcF; n=5, 800
HIGH- RR; n=5, 800
LOW- RR; n=5, 810
HIGH- T WAVE; n=7, 900
LOW- T WAVE; n=7, 900
HIGH- U WAVE; n=1, 000
LOW- U WAVE; n=1, 000
HIGH- ECG; n=7, 900
LOW- ECG; n=7, 900

Adverse events

Collected over Up to Day 35. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Normal Liver Function—0/7 (0%)3/7 (42.9%)
Moderate Hepatic Impairment—1/9 (11.1%)5/9 (55.6%)
Most frequent serious events
Most frequent serious events
EventNormal Liver FunctionModerate Hepatic Impairment
Upper gastrointestinal haemorrhageGastrointestinal disorders0/71/9
Most frequent other events
Showing 10 of 17
Most frequent other events
EventNormal Liver FunctionModerate Hepatic Impairment
DiarrhoeaGastrointestinal disorders3/71/9
NauseaGastrointestinal disorders1/73/9
FatigueGeneral disorders0/73/9
Abdominal discomfortGastrointestinal disorders0/72/9
NasopharyngitisInfections and infestations1/70/9
Micturition UrgencyRenal and urinary disorders1/70/9
Abdominal distensionGastrointestinal disorders0/71/9
DyspepsiaGastrointestinal disorders0/71/9
FlatulenceGastrointestinal disorders0/71/9
VomitingGastrointestinal disorders0/71/9

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Normal Liver FunctionModerate Hepatic ImpairmentTotal
<=18 years000
Between 18 and 65 years7916
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Normal Liver FunctionModerate Hepatic ImpairmentTotal
Female235
Male5611
08

Study locations

8 sites
  • Chicago, Illinois 60612, United States
  • Somers Point, New Jersey 08244, United States
  • Voorhees, New Jersey 08043, United States
  • Philadelphia, Pennsylvania 19104, United States
  • Dallas, Texas 75204, United States
  • Ottawa, Ontario K1H 8L6, Canada
  • Toronto, Ontario M5G 2C4, Canada
  • San Juan, 00927, Puerto Rico
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00435929
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Feb 16, 2007
Start date
Sep 2006
Primary completion
Nov 2009
Completion
Nov 2009
Results posted
Jan 8, 2016
Last update
Mar 29, 2018

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions 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.

Other studies in this condition

Infections→

Other studies from this sponsor

Hoffmann-La Roche

Start the discussion