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

Sponsor
ViiV Healthcare (Industry)
Overall Status
Completed
CT.gov ID
NCT01803074
Collaborator
GlaxoSmithKline (Industry)
107
Enrollment
1
Location
13
Arms
19.8
Actual Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
107 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Apr 4, 2013
Actual Primary Completion Date :
Nov 29, 2014
Actual Study Completion Date :
Nov 29, 2014

Arms and Interventions

Arm Intervention/Treatment
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

Drug: BMS-955176
BMS-955176

Drug: Placebo matching with BMS-955176
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

Drug: BMS-955176
BMS-955176

Drug: Placebo matching with BMS-955176
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

Drug: BMS-955176
BMS-955176

Drug: Placebo matching with BMS-955176
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

Drug: BMS-955176
BMS-955176

Drug: Placebo matching with BMS-955176
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

Drug: BMS-955176
BMS-955176

Drug: Atazanavir
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

Drug: BMS-955176
BMS-955176

Drug: Atazanavir
Atazanavir

Drug: Ritonavir
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

Drug: Atazanavir
Atazanavir

Drug: Ritonavir
Ritonavir

Drug: Tenofovir
Tenofovir

Drug: Emtricitabine
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

Drug: BMS-955176
BMS-955176

Drug: Placebo matching with BMS-955176
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

Drug: BMS-955176
BMS-955176

Drug: Placebo matching with BMS-955176
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

Drug: BMS-955176
BMS-955176

Drug: Placebo matching with BMS-955176
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

Drug: BMS-955176
BMS-955176

Drug: Placebo matching with BMS-955176
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

Drug: BMS-955176
BMS-955176

Drug: Atazanavir
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

Drug: BMS-955176
BMS-955176

Drug: Placebo matching with BMS-955176
Placebo matching with BMS-955176

Outcome Measures

Primary Outcome Measures

  1. Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 [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.

Secondary Outcome Measures

  1. Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C [Pre-dose Day 1 and Day 10]

    Time to reach the maximum plasma concentration was directly determined from concentration time data.

  2. 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 [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.

  3. Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C [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.

  4. Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B [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.

  5. Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C [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.

  6. Time to Maximum Decline in Log 10 HIV-1 RNA - Part B [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.

  7. Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C [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.

  8. Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B [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.

  9. Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C [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.

  10. Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B [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.

  11. Time to Reach Maximum Plasma Concentration (Tmax) - Part B [Pre-dose Day 1 and Day 28]

    Tmax was directly determined from concentration time data.

  12. Maximum Observed Plasma Concentrations (Cmax) - Part A and C [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.

  13. Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C [24 hours post-dose]

    C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose.

  14. Maximum Observed Plasma Concentrations (Cmax) - Part B [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.

  15. Plasma Concentration 24 Hours Post-Dose (C24) - Part B [24 hours post-dose]

    C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose.

  16. Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C [Pre-dose Day 1 and Day 10]

    AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval.

  17. Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B [Pre-dose Day 1 and Day 28]

    AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval.

  18. Accumulation Index (AI): Part A and C [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.

  19. Apparent Total Body Clearance: Part A and C [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).

  20. Degree of Fluctuation (DF): Part A and C [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).

  21. Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C [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).

  22. Plasma Half-life: Part A and C [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).

  23. Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline [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.

  24. Number of Participants With Clinically Significant Changes in Heart Rate [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.

  25. Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) [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.

  26. Number of Participants With Abnormal Changes in Physical Examination [Day 1 to end of the study (Day 42)]

    Participants with abnormal changes in physical examination is presented.

  27. Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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:

  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Berlin Germany 13353

Sponsors and Collaborators

  • ViiV Healthcare
  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01803074
Other Study ID Numbers:
  • 206739
  • 2012-004124-38
  • AI468-002
First Posted:
Mar 4, 2013
Last Update Posted:
Nov 25, 2019
Last Verified:
Nov 1, 2019
Additional relevant MeSH terms:
Infections
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Ritonavir
Atazanavir Sulfate
Tenofovir
Emtricitabine
BMS-955176

Study Results

Participant Flow

Recruitment Details The study was conducted at 3 centers in 3 countries (1 in Germany, 1 in the United Kingdom, 1 in South Africa) from 04-April-2013 to 29-November-2014.
Pre-assignment Detail Participants screened were 191 of which 84 were screen failures (Participant withdrew consent: 3, Pregnancy: 3, Participant no longer meets study criteria: 73, Not according to participant's schedule: 1, Not included since cohort was closed: 3 and back up participant: 1). Only 107 participants (Part A: 60; Part B: 28; and Part C: 19) were enrolled.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Placebo Clade B Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine Part B-Group 12: BMS-955176 (80 mg) + Atazanavir Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg) Placebo Clade C
Arm/Group Description Participants infected with Human Immunodeficiency Virus Type-1 (HIV-1) clade B were treated with 5 milligrams (mg) BMS-955176 as oral suspension, once daily (QD) from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Period Title: Period 1: Part A (HIV-1 Clade B)
STARTED 8 8 8 8 8 8 12 0 0 0 0 0 0 0
COMPLETED 8 8 8 8 8 8 12 0 0 0 0 0 0 0
NOT COMPLETED 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Period 1: Part A (HIV-1 Clade B)
STARTED 0 0 0 0 0 0 0 8 8 4 8 0 0 0
COMPLETED 0 0 0 0 0 0 0 8 8 4 8 0 0 0
NOT COMPLETED 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Period Title: Period 1: Part A (HIV-1 Clade B)
STARTED 0 0 0 0 0 0 0 0 0 0 0 8 7 4
COMPLETED 0 0 0 0 0 0 0 0 0 0 0 8 7 4
NOT COMPLETED 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Baseline Characteristics

Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Placebo Clade B Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine Part B-Group 12: BMS-955176 (80 mg) + Atazanavir Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg) Placebo Clade C Total
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Total of all reporting groups
Overall Participants 8 8 8 8 8 8 12 8 8 4 8 8 7 4 107
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
41.6
(8.73)
37.5
(11.07)
33.3
(7.19)
39.5
(8.09)
36.3
(11.23)
38.0
(9.49)
36.3
(7.12)
33.0
(7.21)
36.3
(9.24)
32.8
(10.21)
34.3
(6.80)
33.6
(7.80)
35.4
(9.59)
35.3
(8.54)
36.1
(8.54)
Sex: Female, Male (Count of Participants)
Female
0
0%
1
12.5%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
3
37.5%
2
28.6%
2
50%
8
7.5%
Male
8
100%
7
87.5%
8
100%
8
100%
8
100%
8
100%
12
100%
8
100%
8
100%
4
100%
8
100%
5
62.5%
5
71.4%
2
50%
99
92.5%
Race/Ethnicity, Customized (Count of Participants)
White
6
75%
7
87.5%
8
100%
8
100%
8
100%
8
100%
12
100%
6
75%
8
100%
4
100%
7
87.5%
2
25%
0
0%
0
0%
84
78.5%
Black/African American
0
0%
1
12.5%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
12.5%
5
62.5%
7
100%
3
75%
17
15.9%
American Indian/Alaska
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
12.5%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
0.9%
Other
2
25%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
12.5%
0
0%
0
0%
0
0%
1
12.5%
0
0%
1
25%
5
4.7%

Outcome Measures

1. Primary Outcome
Title Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11
Description 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.
Time Frame Baseline (Day 1) and Day 11 after the final dose with BMS-955176

Outcome Measure Data

Analysis Population Description
All Treated Subjects Population comprised of all participants who had received at least one dose of study drug.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine Part B-Group 12: BMS-955176 (80 mg) + Atazanavir Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg) Placebo Clade B Placebo Clade C
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 8 8 8 8 8 8 8 8 4 8 8 7 12 4
Mean (Standard Deviation) [Log10 copies per milliliter (c/mL)]
-0.138
(0.1281)
-0.567
(0.5845)
-0.889
(0.6582)
-1.279
(0.4596)
-1.339
(0.29)
-1.326
(0.3855)
-1.216
(0.4366)
-1.431
(0.2967)
-1.544
(0.4155)
-1.521
(0.2651)
-1.29
(0.3376)
-0.938
(0.6897)
0.118
(0.5277)
-0.172
(0.7876)
2. Secondary Outcome
Title Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C
Description Time to reach the maximum plasma concentration was directly determined from concentration time data.
Time Frame Pre-dose Day 1 and Day 10

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population comprised of all participants who received any study medication and had any available concentration-time data.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg)
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 8 8 8 8 8 8 8 7
Day 1
3
2.51
3
4
3.5
3
3.5
3.53
Day 10
3
3
4
3
3
2.5
3
3
3. Secondary Outcome
Title 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
Description 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.
Time Frame Day 1 to end of the study (Day 42)

Outcome Measure Data

Analysis Population Description
All Treated Subjects Population.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine Part B-Group 12: BMS-955176 (80 mg) + Atazanavir Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg) Placebo Clade B Placebo Clade C
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 8 8 8 8 8 8 8 8 4 8 8 7 12 4
Deaths
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
SAEs
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Related SAEs
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Discontinuations due to SAEs
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Discontinuations due to AEs
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
AEs
5
62.5%
5
62.5%
5
62.5%
6
75%
8
100%
7
87.5%
8
66.7%
8
100%
4
50%
6
150%
7
87.5%
6
75%
9
128.6%
3
75%
4. Secondary Outcome
Title Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C
Description 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 Frame Baseline (Day 1) up to Day 24

Outcome Measure Data

Analysis Population Description
All Treated Subjects Population.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg) Placebo Clade B Placebo Clade C
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 8 8 8 8 8 8 8 7 12 4
Median (Full Range) [Log10 copies/mL]
-0.498
-0.976
-1.115
-1.701
-1.555
-1.654
-1.352
-1.257
-0.381
-0.419
5. Secondary Outcome
Title Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B
Description 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 Frame Baseline (Day 1) up to Day 42

Outcome Measure Data

Analysis Population Description
All Treated Subjects Population.
Arm/Group Title Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Arm/Group Description Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
Measure Participants 8 8 4 8
Median (Full Range) [Log10 copies/mL]
-1.858
-2.202
-2.39
-2.228
6. Secondary Outcome
Title Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C
Description 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 Frame Baseline (Day 1) up to Day 24

Outcome Measure Data

Analysis Population Description
All Treated Subjects Population.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg) Placebo Clade B Placebo Clade C
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 8 8 8 8 8 8 8 7 12 4
Median (Full Range) [Hours]
168
216
203.9
240.15
204
240.2
228.05
215.8
216.2
132.05
7. Secondary Outcome
Title Time to Maximum Decline in Log 10 HIV-1 RNA - Part B
Description 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 Frame Baseline (Day 1) up to Day 42

Outcome Measure Data

Analysis Population Description
All Treated Subjects Population.
Arm/Group Title Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Arm/Group Description Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
Measure Participants 8 8 4 8
Median (Full Range) [Hours]
624
636.05
588
636.05
8. Secondary Outcome
Title Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C
Description 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 Frame Baseline (Day 1) up to Day 24

Outcome Measure Data

Analysis Population Description
All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg) Placebo Clade B Placebo Clade C
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 6 7 7 7 8 7 6 6 9 4
CD4+
-21.8
(88.37)
14.6
(120.82)
-70.1
(68.49)
-23.6
(42.13)
-43.8
(69.5)
-56.7
(78.26)
-53.7
(93.76)
24.5
(57.58)
-77.3
(91.05)
18
(67.3)
CD8+
-95
(301.52)
-8.3
(236.48)
-107.4
(264.26)
-57.3
(126.25)
-194.6
(182.3)
-161.3
(203.01)
-214.4
(390.13)
-155.8
(56.55)
-93.1
(138.52)
-136.3
(224.49)
9. Secondary Outcome
Title Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B
Description 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 Frame Baseline (Day 1) up to Day 42

Outcome Measure Data

Analysis Population Description
All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Arm/Group Description Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
Measure Participants 5 7 4 4
CD4+
-133.2
(84.14)
-106.4
(166.59)
33
(144.79)
-89
(35.71)
CD8+
-442.8
(243.99)
-466.1
(491.21)
-216.3
(287.06)
-147
(140.67)
10. Secondary Outcome
Title Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C
Description 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 Frame Baseline (Day 1) up to Day 24

Outcome Measure Data

Analysis Population Description
All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg) Placebo Clade B Placebo Clade C
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 6 7 7 7 8 7 6 6 9 4
CD4+
2.33
(2.944)
0.29
(2.215)
-1.29
(5.057)
0.86
(3.288)
2.13
(3.399)
0.29
(2.87)
0.5
(3.017)
3.17
(3.371)
-0.22
(3.93)
2.75
(3.775)
CD8+
1.17
(2.401)
0.43
(3.207)
0
(6.325)
1
(3.225)
-0.25
(5.064)
-2.29
(2.812)
0
(1.871)
-4.25
(3.775)
1.75
(4.2)
-1.33
(5.132)
11. Secondary Outcome
Title Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B
Description 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 Frame Baseline (Day 1) up to Day 42

Outcome Measure Data

Analysis Population Description
All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Arm/Group Description Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
Measure Participants 5 8 4 4
CD4+
2.4
(2.881)
3.25
(3.105)
4.75
(2.217)
-0.75
(1.893)
CD8+
-2.8
(1.924)
-6.25
(4.464)
-3.75
(2.062)
-1.25
(2.217)
12. Secondary Outcome
Title Time to Reach Maximum Plasma Concentration (Tmax) - Part B
Description Tmax was directly determined from concentration time data.
Time Frame Pre-dose Day 1 and Day 28

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population.
Arm/Group Title Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Arm/Group Description Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
Measure Participants 8 8 8
Day 1
5.01
5.05
5
Day 28
4.5
5
4.5
13. Secondary Outcome
Title Maximum Observed Plasma Concentrations (Cmax) - Part A and C
Description Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time Frame Pre-dose Day 1 and Day 10

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg)
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 8 8 8 8 8 8 8 7
Day 1
79.376
(37.6)
201.498
(21.1)
349.466
(23.2)
791.317
(46.8)
1155.448
(27.1)
1515.389
(27.4)
793.569
(21.2)
1907.747
(38.9)
Day 10
170.778
(20.8)
337.379
(20.9)
705.073
(15.4)
1476.166
(17.2)
2466.447
(22.1)
2809.671
(25.5)
1560.122
(17.4)
3377.967
(32.8)
14. Secondary Outcome
Title Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C
Description C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose.
Time Frame 24 hours post-dose

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg)
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 8 8 8 8 8 8 8 7
Day 1
34.946
(28.4)
79.002
(27.2)
154.5
(23.7)
286.268
(15.6)
482.349
(34.3)
624.745
(24.6)
339.173
(30.1)
865.867
(41)
Day 10
81.642
(23.1)
138.775
(34.1)
325.934
(19.4)
713.077
(21.9)
1150.397
(31.5)
1288.985
(26.8)
779.438
(24.6)
1691.306
(29)
15. Secondary Outcome
Title Maximum Observed Plasma Concentrations (Cmax) - Part B
Description Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time Frame Pre-dose Day 1 and Day 28

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population.
Arm/Group Title Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Arm/Group Description Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
Measure Participants 8 8 8
Day 1
695.596
(9.52)
770.975
(28.2)
1493.336
(24)
Day 28
1667.817
(30.2)
1852
(33.6)
3159.181
(22.1)
16. Secondary Outcome
Title Plasma Concentration 24 Hours Post-Dose (C24) - Part B
Description C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose.
Time Frame 24 hours post-dose

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population.
Arm/Group Title Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Arm/Group Description Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
Measure Participants 8 8 8
Day 1
462.312
(25)
520.048
(27.7)
899.364
(21.2)
Day 28
1099.313
(37)
1163.177
(30.9)
2010.679
(19.9)
17. Secondary Outcome
Title Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C
Description AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval.
Time Frame Pre-dose Day 1 and Day 10

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg)
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 8 8 8 8 8 8 8 7
Day 1
1151.062
(32.2)
2869.626
(21.3)
5132.951
(21.5)
10088.23
(23.1)
17057.26
(29)
21872.72
(27)
10936.9
(29.9)
26753.74
(35.9)
Day 10
2720.237
(20.7)
5168.553
(23.6)
11751.82
(15.1)
22984.83
(17.2)
39341.11
(24.2)
44182.4
(27)
25556.64
(20.4)
53972.71
(30.2)
18. Secondary Outcome
Title Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B
Description AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval.
Time Frame Pre-dose Day 1 and Day 28

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population.
Arm/Group Title Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Arm/Group Description Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose.
Measure Participants 8 8 8
Day 1
12147.23
(15.2)
12954.8
(26.2)
24478.35
(22.6)
Day 28
31406.32
(31.7)
34225.08
(30.6)
59915.72
(16.3)
19. Secondary Outcome
Title Accumulation Index (AI): Part A and C
Description 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.
Time Frame Baseline and Day 10

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg)
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 8 8 8 8 8 8 8 7
Cmax
2.152
(42.9)
1.674
(31.1)
2.018
(39.8)
1.856
(33.6)
2.135
(16.6)
1.854
(22.7)
1.966
(17.2)
1.771
(42.6)
C24
2.336
(21.9)
1.757
(35)
2.11
(29.5)
2.491
(24.9)
2.385
(25.1)
2.063
(19.3)
2.298
(28.4)
1.953
(42.1)
AUC
2.363
(25.9)
1.801
(30.4)
2.289
(39.7)
2.278
(28.2)
2.306
(19)
2.02
(19.7)
2.337
(26.1)
2.017
(39)
20. Secondary Outcome
Title Apparent Total Body Clearance: Part A and C
Description 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).
Time Frame Baseline (Day 1) to Day 10

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg)
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 8 8 8 8 8 8 8 7
Geometric Mean (Geometric Coefficient of Variation) [Milliliters/minute]
30.635
(18.3)
32.246
(28)
28.364
(15.5)
29.005
(18.8)
33.892
(23.8)
45.267
(34)
26.086
(21.3)
37.056
(33.7)
21. Secondary Outcome
Title Degree of Fluctuation (DF): Part A and C
Description 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).
Time Frame Baseline (Day 1) to Day 10

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg)
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 8 8 8 8 8 8 8 7
Geometric Mean (Geometric Coefficient of Variation) [Ratio]
0.766
(29.4)
0.912
(15.2)
0.758
(20.2)
0.78
(22.1)
0.779
(28.5)
0.818
(17.1)
0.723
(13.7)
0.727
(24.5)
22. Secondary Outcome
Title Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C
Description 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).
Time Frame Baseline (Day 1) to Day 10

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg)
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 8 8 8 8 8 8 8 7
Geometric Mean (Geometric Coefficient of Variation) [Nanogram/milliliter]
113.326
(20.7)
215.111
(23.8)
489.507
(15.1)
956.222
(17.3)
1639.471
(24.2)
1841.413
(27)
1065.435
(19.9)
2256.793
(30.2)
23. Secondary Outcome
Title Plasma Half-life: Part A and C
Description 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).
Time Frame Baseline (Day 1) to Day 10

Outcome Measure Data

Analysis Population Description
Pharmacokinetic Population
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg)
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 8 8 8 8 8 8 8 7
Median (Full Range) [Hours]
32.134
31.967
27.382
33.475
29.171
34.574
31.565
35.278
24. Secondary Outcome
Title Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline
Description 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.
Time Frame Day 1 to up to end of the study (Day 42)

Outcome Measure Data

Analysis Population Description
All Treated Subjects Population.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine Part B-Group 12: BMS-955176 (80 mg) + Atazanavir Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg) Placebo Clade B Placebo Clade C
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 8 8 8 8 8 8 8 8 4 8 8 7 12 4
Neutrophils (Absolute)
0
0%
0
0%
0
0%
0
0%
0
0%
1
12.5%
0
0%
0
0%
0
0%
1
25%
0
0%
0
0%
0
0%
0
0%
Bilirubin (Total)
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
2
16.7%
5
62.5%
3
37.5%
0
0%
0
0%
0
0%
0
0%
0
0%
25. Secondary Outcome
Title Number of Participants With Clinically Significant Changes in Heart Rate
Description 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.
Time Frame Day 1 to end of the study (Day 42)

Outcome Measure Data

Analysis Population Description
All Treated Subjects Population.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine Part B-Group 12: BMS-955176 (80 mg) + Atazanavir Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg) Placebo Clade B Placebo Clade C
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 8 8 8 8 8 8 8 8 4 8 8 7 12 4
Count of Participants [Participants]
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
12.5%
0
0%
0
0%
2
25%
1
14.3%
0
0%
26. Secondary Outcome
Title Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Description 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.
Time Frame Day 1 to end of the study (Day 42)

Outcome Measure Data

Analysis Population Description
All Treated Subjects Population.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine Part B-Group 12: BMS-955176 (80 mg) + Atazanavir Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg) Placebo Clade B Placebo Clade C
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 8 8 8 8 8 8 8 8 4 8 8 7 12 4
PR > 200 msec
1
12.5%
1
12.5%
1
12.5%
0
0%
0
0%
2
25%
0
0%
1
12.5%
1
12.5%
1
25%
1
12.5%
0
0%
0
0%
0
0%
QRS > 120 msec
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
8.3%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
QT > 500 msec
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
QTcB > 450 msec
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
25%
QTcF > 450 msec
0
0%
0
0%
1
12.5%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
27. Secondary Outcome
Title Number of Participants With Abnormal Changes in Physical Examination
Description Participants with abnormal changes in physical examination is presented.
Time Frame Day 1 to end of the study (Day 42)

Outcome Measure Data

Analysis Population Description
All Treated Subjects Population.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine Part B-Group 12: BMS-955176 (80 mg) + Atazanavir Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg) Placebo Clade B Placebo Clade C
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 8 8 8 8 8 8 8 8 4 8 8 7 12 4
Height
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Weight
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Body mass index
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
28. Secondary Outcome
Title Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Description 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.
Time Frame Day 1 to end of the study (Day 42)

Outcome Measure Data

Analysis Population Description
All Treated Subjects Population.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine Part B-Group 12: BMS-955176 (80 mg) + Atazanavir Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg) Placebo Clade B Placebo Clade C
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
Measure Participants 8 8 8 8 8 8 8 8 4 8 8 7 12 4
SBP
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
1
12.5%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
DBP
0
0%
1
12.5%
1
12.5%
0
0%
0
0%
0
0%
0
0%
1
12.5%
0
0%
1
25%
1
12.5%
0
0%
1
14.3%
0
0%

Adverse Events

Time Frame Day 1 to up to end of the study (Day 42)
Adverse Event Reporting Description All Treated Subjects comprised of all participants who had received at least one dose of study medication were analyzed.
Arm/Group Title Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Placebo Clade B Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine Part B-Group 12: BMS-955176 (80 mg) + Atazanavir Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg) Placebo Clade C
Arm/Group Description Participants infected with HIV-1 clade B were treated with 5 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 10 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 20 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10 under fasting condition. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with matching placebo QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS 955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 40 mg BMS-955176 as oral suspension, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 300 mg tenofovir, 200 mg emtricitabine, 300 mg atazanavir capsules and 100 mg ritonavir tablets, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade B were treated with 80 mg BMS-955176 as oral suspension and 400 mg atazanavir (2*200 mg) capsules, QD from Day 1 to Day 28 with breakfast. Participants were evaluated for a total period of 42 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 40 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with 120 mg BMS-955176 as oral suspension, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose. Participants infected with HIV-1 clade C were treated with matching placebo, QD from Day 1 to Day 10. Participants were evaluated for a total period of 24 days from the day of first dose.
All Cause Mortality
Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Placebo Clade B Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine Part B-Group 12: BMS-955176 (80 mg) + Atazanavir Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg) Placebo Clade C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Serious Adverse Events
Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Placebo Clade B Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine Part B-Group 12: BMS-955176 (80 mg) + Atazanavir Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg) Placebo Clade C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Other (Not Including Serious) Adverse Events
Part A-Group 1: BMS-955176 (5 mg) Part A-Group 2: BMS-955176 (10 mg) Part A-Group 3: BMS-955176 (20 mg) Part A-Group 4: BMS-955176 (40 mg) Part A-Group 9: BMS-955176 (80 mg) Part A-Group 10: BMS-955176 (120 mg) Placebo Clade B Part B-Group 5: BMS-955176 (40 mg) + Atazanavir Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine Part B-Group 12: BMS-955176 (80 mg) + Atazanavir Part C-Group 8: BMS-955176 (40 mg) Part C-Group 13: BMS-955176 (120 mg) Placebo Clade C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 5/8 (62.5%) 5/8 (62.5%) 5/8 (62.5%) 6/8 (75%) 8/8 (100%) 7/8 (87.5%) 9/12 (75%) 8/8 (100%) 8/8 (100%) 4/4 (100%) 6/8 (75%) 7/8 (87.5%) 6/7 (85.7%) 3/4 (75%)
Blood and lymphatic system disorders
Neutropenia 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/12 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/4 (0%) 1/8 (12.5%) 2/8 (25%) 0/7 (0%) 0/4 (0%)
Eosinophilia 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 1/7 (14.3%) 0/4 (0%)
Ear and labyrinth disorders
External ear pain 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Eye disorders
Ocular icterus 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 1/8 (12.5%) 3/8 (37.5%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Eye pain 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 1/8 (12.5%) 0/7 (0%) 0/4 (0%)
Conjunctival haemorrhage 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Dry eye 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 1/8 (12.5%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Eye irritation 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 1/8 (12.5%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Foreign body sensation in eyes 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Gastrointestinal disorders
Diarrhoea 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 2/8 (25%) 0/12 (0%) 3/8 (37.5%) 2/8 (25%) 2/4 (50%) 3/8 (37.5%) 0/8 (0%) 2/7 (28.6%) 0/4 (0%)
Constipation 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 1/8 (12.5%) 1/8 (12.5%) 0/4 (0%) 1/8 (12.5%) 2/8 (25%) 0/7 (0%) 1/4 (25%)
Abdominal pain 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 1/8 (12.5%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Abdominal pain upper 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 1/4 (25%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Abdominal pain lower 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 1/8 (12.5%) 1/7 (14.3%) 0/4 (0%)
Nausea 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 1/4 (25%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Vomiting 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 1/4 (25%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Toothache 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 1/8 (12.5%) 0/7 (0%) 0/4 (0%)
Dry mouth 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 1/8 (12.5%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Abdominal distension 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Faeces hard 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Flatulence 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Gastrointestinal sounds abnormal 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 1/4 (25%)
Haemorrhoids thrombosed 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Lip swelling 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 1/7 (14.3%) 0/4 (0%)
General disorders
Fatigue 1/8 (12.5%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 1/4 (25%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 1/4 (25%)
Nodule 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 1/8 (12.5%) 0/7 (0%) 0/4 (0%)
Malaise 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 1/7 (14.3%) 0/4 (0%)
Chills 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Asthenia 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Catheter site related reaction 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 1/8 (12.5%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Sensation of foreign body 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Hepatobiliary disorders
Jaundice 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 2/8 (25%) 4/8 (50%) 3/4 (75%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Hyperbilirubinaemia 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 3/8 (37.5%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Infections and infestations
Nasopharyngitis 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 2/8 (25%) 0/8 (0%) 2/12 (16.7%) 1/8 (12.5%) 0/8 (0%) 2/4 (50%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Herpes zoster 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 1/8 (12.5%) 0/7 (0%) 0/4 (0%)
Candida infection 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 1/7 (14.3%) 0/4 (0%)
Folliculitis 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 1/7 (14.3%) 0/4 (0%)
Rhinitis 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 1/8 (12.5%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Gonorrhoea 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 1/8 (12.5%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Hordeolum 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Lower respiratory tract infection 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 1/8 (12.5%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Pulpitis dental 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Sinusitis 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Investigations
Blood bilirubin increased 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 6/8 (75%) 8/8 (100%) 4/4 (100%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Weight decreased 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Alanine aminotransferase increased 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Blood bilirubin unconjugated increased 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 1/8 (12.5%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Body temperature increased 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Intraocular pressure increased 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Neutrophil count decreased 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Metabolism and nutrition disorders
Decreased appetite 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 1/4 (25%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Increased appetite 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 1/4 (25%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Musculoskeletal and connective tissue disorders
Myalgia 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 1/8 (12.5%) 0/7 (0%) 0/4 (0%)
Back pain 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 1/4 (25%)
Bone pain 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Groin pain 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Musculoskeletal stiffness 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 1/8 (12.5%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Neck pain 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Pain in extremity 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Nervous system disorders
Headache 2/8 (25%) 3/8 (37.5%) 0/8 (0%) 5/8 (62.5%) 4/8 (50%) 5/8 (62.5%) 5/12 (41.7%) 5/8 (62.5%) 3/8 (37.5%) 2/4 (50%) 4/8 (50%) 4/8 (50%) 2/7 (28.6%) 3/4 (75%)
Dizziness 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 1/8 (12.5%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Poor quality sleep 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 2/8 (25%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Dysaesthesia 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Paraesthesia 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Psychiatric disorders
Abnormal dreams 1/8 (12.5%) 0/8 (0%) 3/8 (37.5%) 1/8 (12.5%) 3/8 (37.5%) 3/8 (37.5%) 3/12 (25%) 3/8 (37.5%) 3/8 (37.5%) 0/4 (0%) 3/8 (37.5%) 2/8 (25%) 0/7 (0%) 0/4 (0%)
Sleep disorder 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 1/4 (25%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Nightmare 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/12 (0%) 2/8 (25%) 0/8 (0%) 1/4 (25%) 0/8 (0%) 1/8 (12.5%) 0/7 (0%) 0/4 (0%)
Agitation 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Mood swings 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Reproductive system and breast disorders
Dysmenorrhea 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 1/7 (14.3%) 0/4 (0%)
Respiratory, thoracic and mediastinal disorders
Epistaxis 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 1/8 (12.5%) 0/7 (0%) 0/4 (0%)
Oropharyngeal pain 0/8 (0%) 0/8 (0%) 2/8 (25%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 1/8 (12.5%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 1/7 (14.3%) 0/4 (0%)
Nasal congestion 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 1/8 (12.5%) 1/4 (25%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Cough 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Skin and subcutaneous tissue disorders
Night sweats 1/8 (12.5%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 1/8 (12.5%) 1/8 (12.5%) 1/12 (8.3%) 1/8 (12.5%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Pruritus 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 2/8 (25%) 2/8 (25%) 2/4 (50%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 1/4 (25%)
Dermatitis 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 1/7 (14.3%) 0/4 (0%)
Acne 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 1/7 (14.3%) 0/4 (0%)
Urticaria 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 1/7 (14.3%) 0/4 (0%)
Rash 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 1/8 (12.5%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Dermatitis allergic 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Dermatitis atopic 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Dry skin 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Eczema 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/12 (8.3%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Erythema 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 1/8 (12.5%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Hyperhidrosis 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Rash papular 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 1/4 (25%)
Vascular disorders
Hypertension 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)
Thrombophlebitis 0/8 (0%) 0/8 (0%) 0/8 (0%) 0/8 (0%) 1/8 (12.5%) 0/8 (0%) 0/12 (0%) 0/8 (0%) 0/8 (0%) 0/4 (0%) 0/8 (0%) 0/8 (0%) 0/7 (0%) 0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

Name/Title GSK Response Center
Organization GlaxoSmithKline
Phone 866-435-7343
Email GSKClinicalSupportHD@gsk.com
Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01803074
Other Study ID Numbers:
  • 206739
  • 2012-004124-38
  • AI468-002
First Posted:
Mar 4, 2013
Last Update Posted:
Nov 25, 2019
Last Verified:
Nov 1, 2019