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

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ClinicalTrials.gov Identifier: NCT01803074
Recruitment Status : Completed
First Posted : March 4, 2013
Results First Posted : November 25, 2019
Last Update Posted : November 25, 2019
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Infection, Human Immunodeficiency Virus
HIV Infections
Interventions Drug: BMS-955176
Drug: Placebo matching with BMS-955176
Drug: Atazanavir
Drug: Ritonavir
Drug: Tenofovir
Drug: Emtricitabine
Enrollment 107
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 Details 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
Hide 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 2: Part B (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 3: Part C (HIV-1 Clade C Only)
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
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
Hide 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 Number of Baseline Participants 8 8 8 8 8 8 12 8 8 4 8 8 7 4 107
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants 12 participants 8 participants 8 participants 4 participants 8 participants 8 participants 7 participants 4 participants 107 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants 12 participants 8 participants 8 participants 4 participants 8 participants 8 participants 7 participants 4 participants 107 participants
Female
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
   0.0%
0
   0.0%
3
  37.5%
2
  28.6%
2
  50.0%
8
   7.5%
Male
8
 100.0%
7
  87.5%
8
 100.0%
8
 100.0%
8
 100.0%
8
 100.0%
12
 100.0%
8
 100.0%
8
 100.0%
4
 100.0%
8
 100.0%
5
  62.5%
5
  71.4%
2
  50.0%
99
  92.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants 12 participants 8 participants 8 participants 4 participants 8 participants 8 participants 7 participants 4 participants 107 participants
White
6
  75.0%
7
  87.5%
8
 100.0%
8
 100.0%
8
 100.0%
8
 100.0%
12
 100.0%
6
  75.0%
8
 100.0%
4
 100.0%
7
  87.5%
2
  25.0%
0
   0.0%
0
   0.0%
84
  78.5%
Black/African American
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
   0.0%
1
  12.5%
5
  62.5%
7
 100.0%
3
  75.0%
17
  15.9%
American Indian/Alaska
0
   0.0%
0
   0.0%
0
   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%
0
   0.0%
0
   0.0%
1
   0.9%
Other
2
  25.0%
0
   0.0%
0
   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%
1
  12.5%
0
   0.0%
1
  25.0%
5
   4.7%
1.Primary Outcome
Title Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 8 4 8 8 7 12 4
Mean (Standard Deviation)
Unit of Measure: 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
Hide Description Time to reach the maximum plasma concentration was directly determined from concentration time data.
Time Frame Pre-dose Day 1 and Day 10
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 7
Median (Full Range)
Unit of Measure: Hours
Day 1
3
(1.5 to 6)
2.51
(2 to 4)
3
(3 to 6)
4
(2 to 6)
3.5
(3 to 4)
3
(1.5 to 6)
3.5
(2 to 10)
3.53
(2 to 4.25)
Day 10
3
(2 to 4)
3
(1.5 to 4)
4
(3 to 16)
3
(2 to 6)
3
(1.5 to 4.02)
2.5
(1.5 to 3.87)
3
(2 to 6)
3
(1.55 to 4)
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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 8 4 8 8 7 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
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
   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
   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
   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
   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
   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
  75.0%
8
 100.0%
7
  87.5%
8
 100.0%
8
 100.0%
4
 100.0%
6
  75.0%
7
  87.5%
6
  85.7%
9
  75.0%
3
  75.0%
4.Secondary Outcome
Title Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 7 12 4
Median (Full Range)
Unit of Measure: Log10 copies/mL
-0.498
(-0.78 to -0.22)
-0.976
(-1.76 to -0.64)
-1.115
(-2.12 to -0.13)
-1.701
(-1.88 to -0.93)
-1.555
(-1.82 to -1.04)
-1.654
(-2.07 to -0.83)
-1.352
(-2.03 to -1.04)
-1.257
(-2.02 to -0.7)
-0.381
(-1.46 to 0.56)
-0.419
(-1.21 to 0.22)
5.Secondary Outcome
Title Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 8 4 8
Median (Full Range)
Unit of Measure: Log10 copies/mL
-1.858
(-2.37 to -1.49)
-2.202
(-3.52 to -1.24)
-2.39
(-3.04 to -1.83)
-2.228
(-2.68 to -1.87)
6.Secondary Outcome
Title Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 7 12 4
Median (Full Range)
Unit of Measure: Hours
168
(72 to 433.4)
216
(48 to 553.5)
203.9
(168 to 288.1)
240.15
(120.1 to 312.1)
204
(168 to 384.6)
240.2
(216 to 288.3)
228.05
(192 to 384.6)
215.8
(120 to 312)
216.2
(24 to 433.8)
132.05
(23.9 to 786.3)
7.Secondary Outcome
Title Time to Maximum Decline in Log 10 HIV-1 RNA - Part B
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 8 4 8
Median (Full Range)
Unit of Measure: Hours
624
(360 to 816)
636.05
(216 to 816.9)
588
(528 to 672.1)
636.05
(528 to 816.3)
8.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 6 7 7 7 8 7 6 6 9 4
Mean (Standard Deviation)
Unit of Measure: Cells/microliter
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 5 7 4 4
Mean (Standard Deviation)
Unit of Measure: Cells/microliter
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 6 7 7 7 8 7 6 6 9 4
Mean (Standard Deviation)
Unit of Measure: Percent change
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 5 8 4 4
Mean (Standard Deviation)
Unit of Measure: Percent change
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
Hide Description Tmax was directly determined from concentration time data.
Time Frame Pre-dose Day 1 and Day 28
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 8 8
Median (Full Range)
Unit of Measure: Hours
Day 1
5.01
(3 to 12)
5.05
(4 to 12)
5
(5 to 6)
Day 28
4.5
(0 to 12)
5
(4 to 6.02)
4.5
(3 to 6)
13.Secondary Outcome
Title Maximum Observed Plasma Concentrations (Cmax) - Part A and C
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram/milliliter
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
Hide Description C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose.
Time Frame 24 hours post-dose
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram/milliliter
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
Hide 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
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Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 8 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram/milliliter
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
Hide Description C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose.
Time Frame 24 hours post-dose
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 8 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram/milliliter
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
Hide 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
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Hide 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)
Hide 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.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram*hour/milliliter
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 8 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram*hour/milliliter
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
Hide 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
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Hide 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)
Hide 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.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 7
Median (Full Range)
Unit of Measure: Hours
32.134
(25.45 to 46.45)
31.967
(23.97 to 43.02)
27.382
(24 to 41.59)
33.475
(25.79 to 42.39)
29.171
(24.32 to 38.02)
34.574
(29.01 to 39.69)
31.565
(24.39 to 51.64)
35.278
(26.65 to 38.71)
24.Secondary Outcome
Title Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 8 4 8 8 7 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
Neutrophils (Absolute)
0
   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%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Bilirubin (Total)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  25.0%
5
  62.5%
3
  75.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
25.Secondary Outcome
Title Number of Participants With Clinically Significant Changes in Heart Rate
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 8 4 8 8 7 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
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
  25.0%
0
   0.0%
0
   0.0%
2
  28.6%
1
   8.3%
0
   0.0%
26.Secondary Outcome
Title Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 8 4 8 8 7 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
PR > 200 msec
1
  12.5%
1
  12.5%
1
  12.5%
0
   0.0%
0
   0.0%
2
  25.0%
0
   0.0%
1
  12.5%
1
  25.0%
1
  12.5%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
QRS > 120 msec
0
   0.0%
0
   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%
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
   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
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
QTcF > 450 msec
0
   0.0%
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
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
27.Secondary Outcome
Title Number of Participants With Abnormal Changes in Physical Examination
Hide Description Participants with abnormal changes in physical examination is presented.
Time Frame Day 1 to end of the study (Day 42)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 8 4 8 8 7 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
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
   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
   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
   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)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 8 8 8 8 8 8 8 8 4 8 8 7 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
SBP
0
   0.0%
0
   0.0%
0
   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%
0
   0.0%
0
   0.0%
DBP
0
   0.0%
1
  12.5%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
1
  12.5%
1
  12.5%
0
   0.0%
1
   8.3%
0
   0.0%
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/12 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/4 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/7 (0.00%)   0/4 (0.00%) 
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/12 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/4 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/7 (0.00%)   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/8 (62.50%)   5/8 (62.50%)   5/8 (62.50%)   6/8 (75.00%)   8/8 (100.00%)   7/8 (87.50%)   9/12 (75.00%)   8/8 (100.00%)   8/8 (100.00%)   4/4 (100.00%)   6/8 (75.00%)   7/8 (87.50%)   6/7 (85.71%)   3/4 (75.00%) 
Blood and lymphatic system disorders                             
Neutropenia † 1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/12 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/4 (0.00%)  1/8 (12.50%)  2/8 (25.00%)  0/7 (0.00%)  0/4 (0.00%) 
Eosinophilia † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Ear and labyrinth disorders                             
External ear pain † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Eye disorders                             
Ocular icterus † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  1/8 (12.50%)  3/8 (37.50%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Eye pain † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/4 (0.00%) 
Conjunctival haemorrhage † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Dry eye † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Eye irritation † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Foreign body sensation in eyes † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders                             
Diarrhoea † 1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  2/8 (25.00%)  0/12 (0.00%)  3/8 (37.50%)  2/8 (25.00%)  2/4 (50.00%)  3/8 (37.50%)  0/8 (0.00%)  2/7 (28.57%)  0/4 (0.00%) 
Constipation † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  1/8 (12.50%)  1/8 (12.50%)  0/4 (0.00%)  1/8 (12.50%)  2/8 (25.00%)  0/7 (0.00%)  1/4 (25.00%) 
Abdominal pain † 1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Abdominal pain upper † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Abdominal pain lower † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/7 (14.29%)  0/4 (0.00%) 
Nausea † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Vomiting † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Toothache † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/4 (0.00%) 
Dry mouth † 1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Abdominal distension † 1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Faeces hard † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Flatulence † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Gastrointestinal sounds abnormal † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/4 (25.00%) 
Haemorrhoids thrombosed † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Lip swelling † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
General disorders                             
Fatigue † 1  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/4 (25.00%) 
Nodule † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/4 (0.00%) 
Malaise † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Chills † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Asthenia † 1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Catheter site related reaction † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Sensation of foreign body † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Hepatobiliary disorders                             
Jaundice † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  2/8 (25.00%)  4/8 (50.00%)  3/4 (75.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Hyperbilirubinaemia † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  3/8 (37.50%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Infections and infestations                             
Nasopharyngitis † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  2/12 (16.67%)  1/8 (12.50%)  0/8 (0.00%)  2/4 (50.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Herpes zoster † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/4 (0.00%) 
Candida infection † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Folliculitis † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Rhinitis † 1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Gonorrhoea † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Hordeolum † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Lower respiratory tract infection † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Pulpitis dental † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Sinusitis † 1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Investigations                             
Blood bilirubin increased † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  6/8 (75.00%)  8/8 (100.00%)  4/4 (100.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Weight decreased † 1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Alanine aminotransferase increased † 1  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Blood bilirubin unconjugated increased † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Body temperature increased † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Intraocular pressure increased † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Neutrophil count decreased † 1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders                             
Decreased appetite † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Increased appetite † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders                             
Myalgia † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/4 (0.00%) 
Back pain † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/4 (25.00%) 
Bone pain † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Groin pain † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Musculoskeletal stiffness † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Neck pain † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Pain in extremity † 1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                             
Anogenital warts † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Nervous system disorders                             
Headache † 1  2/8 (25.00%)  3/8 (37.50%)  0/8 (0.00%)  5/8 (62.50%)  4/8 (50.00%)  5/8 (62.50%)  5/12 (41.67%)  5/8 (62.50%)  3/8 (37.50%)  2/4 (50.00%)  4/8 (50.00%)  4/8 (50.00%)  2/7 (28.57%)  3/4 (75.00%) 
Dizziness † 1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Poor quality sleep † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Dysaesthesia † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Paraesthesia † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Psychiatric disorders                             
Abnormal dreams † 1  1/8 (12.50%)  0/8 (0.00%)  3/8 (37.50%)  1/8 (12.50%)  3/8 (37.50%)  3/8 (37.50%)  3/12 (25.00%)  3/8 (37.50%)  3/8 (37.50%)  0/4 (0.00%)  3/8 (37.50%)  2/8 (25.00%)  0/7 (0.00%)  0/4 (0.00%) 
Sleep disorder † 1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Nightmare † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/12 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  1/4 (25.00%)  0/8 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/4 (0.00%) 
Agitation † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Mood swings † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Reproductive system and breast disorders                             
Dysmenorrhea † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders                             
Epistaxis † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/7 (0.00%)  0/4 (0.00%) 
Oropharyngeal pain † 1  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Nasal congestion † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/4 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Cough † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders                             
Night sweats † 1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  1/8 (12.50%)  1/12 (8.33%)  1/8 (12.50%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Pruritus † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  2/8 (25.00%)  2/8 (25.00%)  2/4 (50.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/4 (25.00%) 
Dermatitis † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Acne † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Urticaria † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/4 (0.00%) 
Rash † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Dermatitis allergic † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Dermatitis atopic † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Dry skin † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Eczema † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/12 (8.33%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Erythema † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Hyperhidrosis † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Rash papular † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/4 (25.00%) 
Vascular disorders                             
Hypertension † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
Thrombophlebitis † 1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/12 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/4 (0.00%) 
1
Term from vocabulary, MedDRA 17.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01803074    
Other Study ID Numbers: 206739
2012-004124-38 ( EudraCT Number )
AI468-002 ( Other Identifier: Bristol-Myers Squibb )
First Submitted: March 1, 2013
First Posted: March 4, 2013
Results First Submitted: January 28, 2019
Results First Posted: November 25, 2019
Last Update Posted: November 25, 2019