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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
 (submitted: November 4, 2019)
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
 (submitted: March 1, 2013)
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
 (submitted: November 4, 2019)
  • 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
 (submitted: March 1, 2013)
  • 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
 (submitted: February 6, 2015)
107
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2013)
70
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 No
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 No
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