Study to Evaluate a HIV Drug for the Treatment of HIV Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01803074

Recruitment Status : Completed

First Posted : March 4, 2013

Results First Posted : November 25, 2019

Last Update Posted : November 25, 2019

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

ViiV Healthcare

Tracking Information

First Submitted Date ^ICMJE

March 1, 2013

First Posted Date ^ICMJE

March 4, 2013

Results First Submitted Date ^ICMJE

January 28, 2019

Results First Posted Date ^ICMJE

November 25, 2019

Last Update Posted Date

November 25, 2019

Actual Study Start Date ^ICMJE

April 4, 2013

Actual Primary Completion Date

November 29, 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 [ Time Frame: Baseline (Day 1) and Day 11 after the final dose with BMS-955176 ]

Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Change in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 monotherapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.

Original Primary Outcome Measures ^ICMJE

Change in plasma HIV-1 RNA levels from baseline on Day 11 with monotherapy [ Time Frame: Baseline (Day 1-predose) and Day 11 after the final dose with BMS-955176 ]

Change History

Current Secondary Outcome Measures ^ICMJE

Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C [ Time Frame: Pre-dose Day 1 and Day 10 ]
Time to reach the maximum plasma concentration was directly determined from concentration time data.
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), and Discontinuations Due to AEs During the Study [ Time Frame: Day 1 to end of the study (Day 42) ]
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.
Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C [ Time Frame: Baseline (Day 1) up to Day 24 ]
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Maximum decline from Baseline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.
Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B [ Time Frame: Baseline (Day 1) up to Day 42 ]
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Maximum decline from Baseline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.
Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C [ Time Frame: Baseline (Day 1) up to Day 24 ]
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Time to maximum decline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.
Time to Maximum Decline in Log 10 HIV-1 RNA - Part B [ Time Frame: Baseline (Day 1) up to Day 42 ]
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Time to maximum decline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.
Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C [ Time Frame: Baseline (Day 1) up to Day 24 ]
Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.
Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B [ Time Frame: Baseline (Day 1) up to Day 42 ]
Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.
Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C [ Time Frame: Baseline (Day 1) up to Day 24 ]
Percent Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.
Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B [ Time Frame: Baseline (Day 1) up to Day 42 ]
Percent Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.
Time to Reach Maximum Plasma Concentration (Tmax) - Part B [ Time Frame: Pre-dose Day 1 and Day 28 ]
Tmax was directly determined from concentration time data.
Maximum Observed Plasma Concentrations (Cmax) - Part A and C [ Time Frame: Pre-dose Day 1 and Day 10 ]
Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C [ Time Frame: 24 hours post-dose ]
C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose.
Maximum Observed Plasma Concentrations (Cmax) - Part B [ Time Frame: Pre-dose Day 1 and Day 28 ]
Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Plasma Concentration 24 Hours Post-Dose (C24) - Part B [ Time Frame: 24 hours post-dose ]
C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose.
Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C [ Time Frame: Pre-dose Day 1 and Day 10 ]
AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval.
Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B [ Time Frame: Pre-dose Day 1 and Day 28 ]
AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval.
Accumulation Index (AI): Part A and C [ Time Frame: Baseline and Day 10 ]
Accumulation index was calculated by dividing the AUC(tau) or Cmax or C24 of BMS-955176 on Day 10 by the AUC(TAU) or Cmax or C24, respectively, of BMS-955176 on Day 1.
Apparent Total Body Clearance: Part A and C [ Time Frame: Baseline (Day 1) to Day 10 ]
Apparent total body clearance was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7).
Degree of Fluctuation (DF): Part A and C [ Time Frame: Baseline (Day 1) to Day 10 ]
DF was calculated as the difference between Cmax and Cmin divided by Css-avg. DF was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7).
Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C [ Time Frame: Baseline (Day 1) to Day 10 ]
Css-avg was calculated by the quotient of AUC(TAU) and the dosing interval (24 h). Css-avg was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7).
Plasma Half-life: Part A and C [ Time Frame: Baseline (Day 1) to Day 10 ]
Half-life of the terminal log-linear phase, (T-half), was calculated as natural logarithm of 2 (ln2)/λ, where λ is the absolute value of the slope of the terminal log-linear phase. T-half was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7).
Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline [ Time Frame: Day 1 to up to end of the study (Day 42) ]
Laboratory abnormalities were determined and graded using the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004.
Number of Participants With Clinically Significant Changes in Heart Rate [ Time Frame: Day 1 to end of the study (Day 42) ]
Heart rate was measured after the participants had been seated quietly for at least 5 minutes. Criteria used to determine heart rate that are outside of a pre-specified range, where changes from Baseline are based on matched postural positions and are calculated as parameter value - Baseline parameter value: Value >100 and change from Baseline > 30, or Value < 55 and change from Baseline < -15.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) [ Time Frame: Day 1 to end of the study (Day 42) ]
Participants with out of range ECG intervals were summarized. Criteria used to determine ECG results that are outside of a pre-specified range: PR (milliseconds [msec]): Value >200; QRS (msec): Value >120; QT (msec): Value >500 or change from Baseline >30; corrected QT interval Fridericia's formula (QTcF) (msec): Value >450 or change from Baseline >30.
Number of Participants With Abnormal Changes in Physical Examination [ Time Frame: Day 1 to end of the study (Day 42) ]
Participants with abnormal changes in physical examination is presented.
Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [ Time Frame: Day 1 to end of the study (Day 42) ]
Systolic BP (millimeter of mercury [mmHg]): value >140 and change from Baseline >20, or value <90 and change from Baseline <-20; Diastolic BP (mmHg): value >90 and change from Baseline >10, or value <55 and change from Baseline <-10.

Original Secondary Outcome Measures ^ICMJE

Frequency of Adverse events (AEs), serious AEs, discontinuations due to AEs, findings of marked abnormalities in vital signs, clinical laboratory tests, ECG readings and physical examinations [ Time Frame: Up to Day 24 (Parts A and C) or up to Day 42 (Part B) ]
Time course of HIV-1 RNA level change [ Time Frame: Baseline (Day 1), up to Day 24 (Parts A and C) , up to Day 42 (Part B) ]
Change from baseline in CD4+ and CD8+ lymphocyte counts and percentages following monotherapy and combination therapy of BMS-955176 with Atazanavir (ATV)+/-Ritonavir (RTV) in HIV-1 infected subjects [ Time Frame: Baseline (Day 1), up to Day 24 (Parts A and C) , up to Day 42 (Part B) ]
Maximum observed plasma concentration (Cmax) [ Time Frame: 12 time points on Day 1 and Day 10 (Part A and C) and 9 time points on Day 28 (Part B) ]
Steady state trough concentration (Cmin) [ Time Frame: 12 time points on Day 1 and Day 10 (Part A and C) and 9 time points on Day 28 (Part B) ]
Time of maximum observed plasma concentration (Tmax) [ Time Frame: 12 time points on Day 1 and Day 10 (Part A and C) and 9 time points on Day 28 (Part B) ]
Trough observed plasma concentration (Ctrough) [ Time Frame: 12 time points on Day 1 and Day 10 (Part A and C) and 9 time points on Day 28 (Part B) ]
Area under the concentration-time curve in one dosing interval [AUC(TAU)] [ Time Frame: 12 time points on Day 1 and Day 10 (Part A and C) and 9 time points on Day 28 (Part B) ]
Accumulation Index (AI), calculated as ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose [ Time Frame: 12 time points on Day 1 and Day 10 (Part A and C) and 9 time points on Day 28 (Part B) ]
Apparent total body clearance (CLT/F) [ Time Frame: 12 time points on Day 1 and Day 10 (Part A and C) and 9 time points on Day 28 (Part B) ]
Terminal Plasma half-life (T-Half)-after last dose only [ Time Frame: Day 10 (Part A and C) and Day 28 (Part B) ]

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study to Evaluate a HIV Drug for the Treatment of HIV Infection

Official Title ^ICMJE

Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of BMS-955176 (Double-Blinded) and BMS-955176 With Atazanavir +/- Ritonavir (Open-Labeled) in HIV-1 Infected Subjects

Brief Summary

The primary purpose of this study is to study the safety and tolerability of a HIV drug and to evaluate a decrease of HIV-1 virus level in blood after treatments in HIV-1 infected patients

Detailed Description

Masking: Open-Part B. Double Blind-Parts A and C

Gender: Both female and male participants for Parts A and C. Male participants for Part B.

HIV = Human Immunodeficiency Virus RNA = Ribonucleic acid

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Infection, Human Immunodeficiency Virus
HIV Infections

Intervention ^ICMJE

Drug: BMS-955176
BMS-955176
Drug: Placebo matching with BMS-955176
Placebo matching with BMS-955176
Drug: Atazanavir
Atazanavir
Drug: Ritonavir
Ritonavir
Drug: Tenofovir
Tenofovir
Drug: Emtricitabine
Emtricitabine

Study Arms ^ICMJE

Experimental: Part A-Group 1: BMS-955176 (5 mg) or Placebo
BMS-955176 5 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Interventions:
- Drug: BMS-955176
- Drug: Placebo matching with BMS-955176
Experimental: Part A-Group 2: BMS-955176 (10 mg) or Placebo
BMS-955176 10 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Interventions:
- Drug: BMS-955176
- Drug: Placebo matching with BMS-955176
Experimental: Part A-Group 3: BMS-955176 (20 mg) or Placebo
BMS-955176 20 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Interventions:
- Drug: BMS-955176
- Drug: Placebo matching with BMS-955176
Experimental: Part A-Group 4: BMS-955176 (40 mg) or Placebo
BMS-955176 40 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Interventions:
- Drug: BMS-955176
- Drug: Placebo matching with BMS-955176
Experimental: Part B-Group 5: BMS-955176 + Atazanavir
BMS-955176 40 mg solution by mouth once daily for 28 days

Atazanavir 2 x 200 mg capsules by mouth once daily for 28 days
Interventions:
- Drug: BMS-955176
- Drug: Atazanavir
Experimental: Part B-Group 6: BMS-955176 + Atazanavir + Ritonavir
BMS-955176 40 mg solution by mouth once daily for 28 days

Atazanavir 1 x 300 mg capsules by mouth once daily for 28 days

Ritonavir 1 x 100 mg tablet by mouth once daily for 28 days
Interventions:
- Drug: BMS-955176
- Drug: Atazanavir
- Drug: Ritonavir
Experimental: Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Atazanavir 1 x 300 mg capsule by mouth once daily for 28 days

Ritonavir 1 x 100 mg tablet by mouth once daily for 28 days

Tenofovir 1 x 300 mg tablet by mouth once daily for 28 days

Emtricitabine 1 x 200 mg capsule once daily for 28 days
Interventions:
- Drug: Atazanavir
- Drug: Ritonavir
- Drug: Tenofovir
- Drug: Emtricitabine
Experimental: Part C-Group 8: BMS-955176 (40 mg) or Placebo
BMS-955176 40 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Interventions:
- Drug: BMS-955176
- Drug: Placebo matching with BMS-955176
Experimental: Part A-Group 9: BMS-955176 (80 mg) or Placebo
BMS-955176 80 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Interventions:
- Drug: BMS-955176
- Drug: Placebo matching with BMS-955176
Experimental: Part A-Group 10: BMS-955176 (120 mg) or Placebo
BMS-955176 120 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Interventions:
- Drug: BMS-955176
- Drug: Placebo matching with BMS-955176
Experimental: Part A-Group 11 (Optional): BMS-955176 (≤120 mg) or Placebo
BMS-955176 ≤120 mg solution by mouth once daily for 14 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 14 days
Interventions:
- Drug: BMS-955176
- Drug: Placebo matching with BMS-955176
Experimental: Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
BMS-955176 80 mg solution by mouth once daily for 28 days

Atazanavir 2 x 200 mg capsules by mouth once daily for 28 days
Interventions:
- Drug: BMS-955176
- Drug: Atazanavir
Experimental: Part C-Group 13: BMS-955176 (120 mg) or Placebo
BMS-955176 120 mg solution by mouth once daily for 10 days

OR

Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Interventions:
- Drug: BMS-955176
- Drug: Placebo matching with BMS-955176

Publications *

Hwang C, Schürmann D, Sobotha C, Boffito M, Sevinsky H, Ray N, Ravindran P, Xiao H, Keicher C, Hüser A, Krystal M, Dicker IB, Grasela D, Lataillade M. Antiviral Activity, Safety, and Exposure-Response Relationships of GSK3532795, a Second-Generation Human Immunodeficiency Virus Type 1 Maturation Inhibitor, Administered as Monotherapy or in Combination With Atazanavir With or Without Ritonavir in a Phase 2a Randomized, Dose-Ranging, Controlled Trial (AI468002). Clin Infect Dis. 2017 Aug 1;65(3):442-452. doi: 10.1093/cid/cix239.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

107

Original Estimated Enrollment ^ICMJE

Actual Study Completion Date ^ICMJE

November 29, 2014

Actual Primary Completion Date

November 29, 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

Age 18-55 years inclusive
Men and women: (Parts A and C); men only (Part B)
Women of childbearing potential (WOCBP) must not be pregnant and nursing
BMI: 18.0-35.0 kg/m2
Subjects are infected with HIV-1 (clades B or C) and meet following criteria at the screening:

i) Plasma HIV-1 RNA ≥5,000 copies/mL; ii) Antiretroviral treatment naive (defined as <1 week of ARV treatment) or ART-experienced (protease inhibitor and/or maturation inhibitor naive); iii) Subjects are not eligible for HIV-1 treatment based on the United States Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents or have declined initiation of cART iv) CD4+ lymphocyte measurement ≥200 cells/μL; v) In Parts A and B, all subjects are infected with HIV-1 clade B vi) In Part C, all subjects are infected with HIV-1 clade C

Exclusion Criteria:

History of genotypic and/or phenotypic drug resistance testing showing resistance to protease inhibitors
Any significant acute or chronic medical illness which is not stable or is not controlled with medication or not consistent with HIV-1 infection
Receive antiretroviral treatment within 12 weeks prior to screening
Currently co-infected with hepatitis C or hepatitis B
Previously received an HIV maturation inhibitor or HIV protease inhibitor
Current or recent (within 3 months of study drug administration) gastrointestinal disease
Any major surgery within 4 weeks of study drug administration
Acute diarrhea lasting ≥1 day, within 3 weeks prior to randomization
Subjects with history of Gilbert's syndrome
Subjects previously received an HIV maturation inhibitor or HIV protease inhibitor
A personal history of clinically relevant cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de pointes. A personal or family history of long QT syndrome
Patients who are unwilling to practice adequate infection protection during and after study participation to minimize potential for spread of HIV infection, including HIV which may have developed resistance to HIV maturation inhibitor and/or ATV
Any gastrointestinal surgery that could impact upon the absorption of study drug
Smoking >10 cigarettes per day
PR ≥210 msec; QRS ≥120 msec; QT ≥500 msec; and QTcF ≥470 msec for women and ≥450 msec for men
Evidence of second or third degree heart block prior to study drug
Absolute Neutrophil Count <(ANC) 0.7 x lower limit of normal (LLN)
Hemoglobin <0.8 x LLN
Alanine aminotransferase (ALT) >1.25 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) >1.25 x ULN
Total Bilirubin >1.25 x ULN
Creatinine clearance <60 mL/mim
Positive urine screen for drugs of abuse without a valid prescription (subjects positive for cannabinoids and/or amphetamines will be included)
Positive blood screen for hepatitis C virus (HCV) RNA, hepatitis B surface antigen (consistent with active or chronic hepatitis B), or HIV-2 antibody
History of any significant drug allergy

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 55 Years (Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

South Africa

Administrative Information

NCT Number ^ICMJE

NCT01803074

Other Study ID Numbers ^ICMJE

206739
2012-004124-38 ( EudraCT Number )
AI468-002 ( Other Identifier: Bristol-Myers Squibb )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

ViiV Healthcare

Study Sponsor ^ICMJE

ViiV Healthcare

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

ViiV Healthcare

PRS Account

ViiV Healthcare

Verification Date

November 2019

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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