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Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02386098
Recruitment Status : Terminated (GI Intolerability)
First Posted : March 11, 2015
Results First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: BMS-955176
Drug: Atazanavir (ATV)
Drug: Ritonavir (RTV)
Drug: Dolutegravir (DTG)
Drug: Tenofovir (TDF)
Enrollment 86
Recruitment Details This study was planned to be conducted in two Stages (96 weeks each); but was terminated early during Stage 1 due to high rates of gastrointestinal (GI) intolerability and early end of the concurrent, 205891 (NCT02415595) formal dose-finding study. Hence, data was collected only in Stage 1 and no participants were enrolled in Stage 2.
Pre-assignment Details A total of 288 participants were screened, of which 86 were randomized in a ratio of 1:1 to one of the two treatment arms in Stage 1.
Arm/Group Title Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal. Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal. Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks. Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks. Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Period Title: Stage 1 (96 Weeks)
Started 43 43 0 0 0
Completed 0 0 0 0 0
Not Completed 43 43 0 0 0
Reason Not Completed
Other: Administrative reason by sponsor             30             29             0             0             0
Adverse Event             2             1             0             0             0
Lost to Follow-up             2             2             0             0             0
Other:Protocol defined stopping criteria             0             2             0             0             0
Withdrawal by Subject             3             1             0             0             0
Other             1             0             0             0             0
Other: Breach of good clinical practice             5             8             0             0             0
Period Title: Stage 2 (96 Weeks)
Started 0 0 0 0 0
Completed 0 0 0 0 0
Not Completed 0 0 0 0 0
Arm/Group Title Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Total
Hide Arm/Group Description Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal. Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal. Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks. Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks. Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. Total of all reporting groups
Overall Number of Baseline Participants 38 35 0 0 0 73
Hide Baseline Analysis Population Description
Modified intent to treat (mITT) Population comprised of randomized participants who received at least one dose of BMS-955176 or TDF. Data from 13 participants randomized at a single site were excluded due to a breach of good clinical practice (GCP) that indicated participants may not have been properly consented to participate in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 35 participants 0 participants 0 participants 0 participants 73 participants
39.8  (11.45) 41.7  (12.06) 40.7  (11.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 35 participants 0 participants 0 participants 0 participants 73 participants
Female
7
  18.4%
8
  22.9%
15
  20.5%
Male
31
  81.6%
27
  77.1%
58
  79.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 35 participants 0 participants 0 participants 0 participants 73 participants
White
14
  36.8%
17
  48.6%
31
  42.5%
Black/African American
6
  15.8%
2
   5.7%
8
  11.0%
Asian
4
  10.5%
4
  11.4%
8
  11.0%
Unknown
14
  36.8%
12
  34.3%
26
  35.6%
1.Primary Outcome
Title Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24-Stage 1
Hide Description Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA <40 c/mL at Week 24 was assessed using the Food and Drug Administration (FDA) snapshot algorithm which used the last on-treatment plasma HIV-1 RNA measurement, within an FDA-specified visit window (18 to 30 weeks), to determine response. Analysis was performed on the modified intent to treat (mITT) Population which comprised of all randomized participants who received atleast one dose of BMS-955176 or TDF.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Overall Number of Participants Analyzed 38 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
73.7
(56.9 to 86.6)
60.0
(42.1 to 76.1)
2.Primary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Week 24-Stage 2
Hide Description Blood samples were planned to be collected for quantitative analysis of plasma HIV-1 RNA. The analysis was not performed in Stage 2 due to early termination of the study during Stage 1.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1
Hide Description Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Response was assessed using the last plasma HIV-1 RNA value in the predefined visit window to classify a participant's response status. The percentage of responders with HIV-1 RNA <40 c/mL at Weeks 48 and 96 using mITT Population (observed) which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (October 10, 2016) is presented. The study was terminated early during the primary end point analysis of Stage 1; hence, data was not collected for Week 96 analysis.
Time Frame Weeks 48 and 96
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population (observed). Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Overall Number of Participants Analyzed 38 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 48; n=8, 9 Number Analyzed 8 participants 9 participants
75.0
(34.9 to 96.8)
66.7
(29.9 to 92.5)
Week 96; n=0, 0 Number Analyzed 0 participants 0 participants
4.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 2
Hide Description Blood samples were planned to be collected for quantitative analysis of plasma HIV-1 RNA. The analysis was not performed in Stage 2 due to early termination of the study during Stage 1.
Time Frame Weeks 48 and 96
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1
Hide Description Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Response was assessed using the last plasma HIV-1 RNA value in the predefined visit window to classify a participant's response status. The percentage of responders with HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96 using mITT Population (observed) which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (October 10, 2016) is presented. The study was terminated early during the primary end point analysis of Stage 1; hence, data was not collected for Week 96 analysis.
Time Frame Weeks 24, 48 and 96
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population (observed). Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Overall Number of Participants Analyzed 38 35
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 24; n=32, 29 Number Analyzed 32 participants 29 participants
93.8
(79.2 to 99.2)
89.7
(72.6 to 97.8)
Week 48; n=8, 9 Number Analyzed 8 participants 9 participants
100
(63.1 to 100.0)
100
(66.4 to 100.0)
Week 96; n=0, 0 Number Analyzed 0 participants 0 participants
6.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 2
Hide Description Blood samples were planned to be collected for quantitative analysis of plasma HIV-1 RNA. The analysis was not performed in Stage 2 due to early termination of the Study during Stage 1.
Time Frame Weeks 24, 48 and 96
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1
Hide Description Blood samples were collected for analysis of HIV-1 RNA. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Change from Baseline in plasma HIV-1 RNA (log10) is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point.
Time Frame Baseline and up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population (observed). Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Overall Number of Participants Analyzed 38 35
Mean (Standard Deviation)
Unit of Measure: log10 c/mL
Week 2; n=10, 5 Number Analyzed 10 participants 5 participants
-4.232  (0.8779) -4.050  (1.3413)
Week 4; n=37, 33 Number Analyzed 37 participants 33 participants
-4.400  (0.8983) -3.922  (1.5241)
Week 8; n=37, 30 Number Analyzed 37 participants 30 participants
-4.103  (1.8696) -4.145  (1.1350)
Week 12; n=36, 32 Number Analyzed 36 participants 32 participants
-4.394  (0.9011) -4.113  (1.1280)
Week 16; n=34, 32 Number Analyzed 34 participants 32 participants
-4.402  (0.9267) -4.074  (1.1437)
Week 24; n=32, 29 Number Analyzed 32 participants 29 participants
-4.220  (1.5130) -4.079  (1.1754)
Week 32; n=23, 23 Number Analyzed 23 participants 23 participants
-4.381  (1.0267) -3.364  (2.7492)
Week 40; n=21, 15 Number Analyzed 21 participants 15 participants
-4.366  (1.0553) -4.400  (1.0572)
Week 48; n=8, 9 Number Analyzed 8 participants 9 participants
-4.508  (1.1333) -4.680  (1.0607)
Week 60; n=4, 3 Number Analyzed 4 participants 3 participants
-5.037  (1.2665) -4.977  (1.4043)
Week 72; n=1, 1 Number Analyzed 1 participants 1 participants
-3.326 [1]   (NA) -5.713 [1]   (NA)
[1]
The standard deviation could not be calculated as a single participant was analyzed at the specified time point.
8.Secondary Outcome
Title Change From Baseline in log10 HIV-1 RNA Over Time-Stage 2
Hide Description This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.
Time Frame Baseline and up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1
Hide Description The CD4+ cell count was assessed using flow cytometry. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point.
Time Frame Baseline and up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population (observed). Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)
Arm/Group Title Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Overall Number of Participants Analyzed 38 35
Mean (Standard Deviation)
Unit of Measure: Cells per microliter
Week 4; n=37, 33 Number Analyzed 37 participants 33 participants
57.6  (93.54) 26.7  (83.30)
Week 8; n=36, 30 Number Analyzed 36 participants 30 participants
77.6  (130.59) 53.7  (76.57)
Week 12; n=35, 32 Number Analyzed 35 participants 32 participants
90.4  (190.31) 115.1  (159.22)
Week 16; n=34, 31 Number Analyzed 34 participants 31 participants
83.2  (116.78) 93.8  (113.61)
Week 24; n=31, 28 Number Analyzed 31 participants 28 participants
127.2  (146.37) 109.5  (124.35)
Week 32; n=23, 22 Number Analyzed 23 participants 22 participants
90.0  (109.70) 122.1  (122.65)
Week 40; n=20, 15 Number Analyzed 20 participants 15 participants
139.5  (82.72) 137.1  (122.36)
Week 48; n=7, 9 Number Analyzed 7 participants 9 participants
125.0  (88.72) 175.1  (64.64)
Week 60; n=4, 2 Number Analyzed 4 participants 2 participants
127.0  (99.39) 158.5  (79.90)
Week 72; n=1, 1 Number Analyzed 1 participants 1 participants
0.0 [1]   (NA) 171.0 [1]   (NA)
[1]
The standard deviation could not be calculated as a single participant was analyzed at the specified time point.
10.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count Over Time-Stage 2
Hide Description This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.
Time Frame Baseline and up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1
Hide Description The percentage of CD4+ cells was assessed using flow cytometry. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point.
Time Frame Baseline and up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population (observed). Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).
Arm/Group Title Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Overall Number of Participants Analyzed 38 35
Mean (Standard Deviation)
Unit of Measure: Percentage of CD4+ cells
Week 4; n=37, 33 Number Analyzed 37 participants 33 participants
1.94  (2.701) 1.82  (2.152)
Week 8; n=36, 30 Number Analyzed 36 participants 30 participants
1.80  (2.495) 1.69  (2.490)
Week 12; n=35, 32 Number Analyzed 35 participants 32 participants
3.41  (3.760) 2.88  (3.084)
Week 16; n=34, 31 Number Analyzed 34 participants 31 participants
3.14  (3.486) 3.66  (3.155)
Week 24; n=31, 28 Number Analyzed 31 participants 28 participants
4.71  (2.914) 4.72  (3.315)
Week 32; n=23, 22 Number Analyzed 23 participants 22 participants
4.13  (3.671) 4.81  (4.237)
Week 40; n=20, 15 Number Analyzed 20 participants 15 participants
5.38  (3.460) 5.38  (3.318)
Week 48; n=7, 9 Number Analyzed 7 participants 9 participants
7.09  (4.271) 7.16  (3.777)
Week 60; n=4, 2 Number Analyzed 4 participants 2 participants
7.95  (2.121) 10.05  (2.616)
Week 72; n=1, 1 Number Analyzed 1 participants 1 participants
12.50 [1]   (NA) 10.70 [1]   (NA)
[1]
The standard deviation could not be calculated as a single participant was analyzed at the specified time point.
12.Secondary Outcome
Title Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 2
Hide Description This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.
Time Frame Baseline and up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1
Hide Description An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or medical events that may jeopardize the participant or require intervention (medical or surgical) to prevent one of the outcomes mentioned before. The number of participants with SAEs and AELDs are presented.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Overall Number of Participants Analyzed 38 35
Measure Type: Count of Participants
Unit of Measure: Participants
SAEs
4
  10.5%
3
   8.6%
AELD
2
   5.3%
1
   2.9%
14.Secondary Outcome
Title Number of Participants With SAEs and AELDs-Stage 2
Hide Description This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1
Hide Description The occurrence of new AIDS defining events that is, Centers for Disease Control (CDC) Class C events in participants is presented.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Overall Number of Participants Analyzed 38 35
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.6%
0
   0.0%
16.Secondary Outcome
Title Number of Participants With Occurrence of New AIDS Defining Events-Stage 2
Hide Description This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Maximum Observed Concentration (Cmax) for BMS-955176-Stage 1
Hide Description The pharmacokinetic (PK) assessments were planned to be performed on PK Population, which comprised of all treated participants who had any available concentration-time data; however, it was not performed due to the early termination of the study in Stage 1.
Time Frame Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Cmax for BMS-955176-Stage 2
Hide Description This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).
Time Frame Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Time of Maximum Observed Plasma Concentration (Tmax) for BMS-955176-Stage 1
Hide Description PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.
Time Frame Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Tmax for BMS-955176-Stage 2
Hide Description This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).
Time Frame Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
21.Secondary Outcome
Title Observed Plasma Concentration at the End of a Dosing Interval (Ctau) for BMS-955176-Stage 1
Hide Description PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.
Time Frame Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Ctau for BMS-955176-Stage 2
Hide Description This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).
Time Frame Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
23.Secondary Outcome
Title Observed Pre-dose Plasma Concentration (C0) for BMS-955176-Stage 1
Hide Description PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.
Time Frame Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
24.Secondary Outcome
Title C0 for BMS-955176-Stage 2
Hide Description This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).
Time Frame Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
25.Secondary Outcome
Title Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) for BMS-955176-Stage 1
Hide Description PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.
Time Frame Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
26.Secondary Outcome
Title AUC(Tau) for BMS-955176-Stage 2
Hide Description This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).
Time Frame Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
27.Secondary Outcome
Title Number of Participants With Emergence of HIV Drug Resistance-Stage 1
Hide Description Emergence of drug resistance was planned to be assessed using the most current version of International AIDS Society-United States of America (IAS-USA); however, it was not assessed due to the early termination of the study in Stage 1.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
28.Secondary Outcome
Title Number of Participants With Emergence of HIV Drug Resistance-Stage 2
Hide Description This end point was not evaluated, as the resulting information would only have been needed to help assess the risk for Stage 2 (which never opened due to the early termination of the study in Stage 1).
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
Arm/Group Title Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description:
Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until Week 96.
Adverse Event Reporting Description AEs and SAEs were collected in Stage 1 in the modified intent to treat (mITT) Population. Data were not collected in Stage 2 as no participants were enrolled in Stage 2.
 
Arm/Group Title Stage 1: BMS955176+ATV/r+DTG Stage 1: TDF+ATV/r+DTG Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Hide Arm/Group Description Participants were administered a once daily (QD) oral dose of 120 milligram (mg) BMS-955176 in combination with atazanavir boosted with ritonavir (ATV/r) 300/100 mg QD and dolutegravir (DTG) 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal. Participants were administered a QD oral dose of 300 mg tenofovir (TDF) in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks. The doses were administered in the morning with a meal. Participants were planned to be administered a QD oral dose of 120 mg BMS-955176 in combination with atazanavir without ritonavir (ATV) 400 mg QD and DTG 50 mg QD for a duration of 96 weeks. Participants were planned to be administered a QD oral dose of 180 mg BMS-955176 in combination with ATV 400 mg QD and DTG 50 mg QD for a duration of 96 weeks. Participants were planned to be administered a QD oral dose of 300 mg TDF in combination with ATV/r 300/100 mg QD and DTG 50 mg QD for a duration of 96 weeks.
All-Cause Mortality
Stage 1: BMS955176+ATV/r+DTG Stage 1: TDF+ATV/r+DTG Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)      0/35 (0.00%)      0/0      0/0      0/0    
Show Serious Adverse Events Hide Serious Adverse Events
Stage 1: BMS955176+ATV/r+DTG Stage 1: TDF+ATV/r+DTG Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/38 (10.53%)      3/35 (8.57%)      0/0      0/0      0/0    
Cardiac disorders           
Cardiomyopathy † 1  1/38 (2.63%)  1 0/35 (0.00%)  0 0/0  0 0/0  0 0/0  0
Gastrointestinal disorders           
Anal haemorrhage † 1  0/38 (0.00%)  0 1/35 (2.86%)  1 0/0  0 0/0  0 0/0  0
Diarrhoea † 1  1/38 (2.63%)  1 0/35 (0.00%)  0 0/0  0 0/0  0 0/0  0
Pancreatic failure † 1  1/38 (2.63%)  1 0/35 (0.00%)  0 0/0  0 0/0  0 0/0  0
Infections and infestations           
Hepatitis C † 1  0/38 (0.00%)  0 1/35 (2.86%)  1 0/0  0 0/0  0 0/0  0
Injury, poisoning and procedural complications           
Overdose † 1  1/38 (2.63%)  1 1/35 (2.86%)  1 0/0  0 0/0  0 0/0  0
Respiratory, thoracic and mediastinal disorders           
Pneumothorax † 1  1/38 (2.63%)  1 0/35 (0.00%)  0 0/0  0 0/0  0 0/0  0
1
Term from vocabulary, MedDRA 19.1
†
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stage 1: BMS955176+ATV/r+DTG Stage 1: TDF+ATV/r+DTG Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/38 (84.21%)      24/35 (68.57%)      0/0      0/0      0/0    
Gastrointestinal disorders           
Abdominal pain † 1  1/38 (2.63%)  2 2/35 (5.71%)  2 0/0  0 0/0  0 0/0  0
Abdominal pain upper † 1  2/38 (5.26%)  3 0/35 (0.00%)  0 0/0  0 0/0  0 0/0  0
Anogenital dysplasia † 1  0/38 (0.00%)  0 2/35 (5.71%)  2 0/0  0 0/0  0 0/0  0
Diarrhoea † 1  20/38 (52.63%)  31 4/35 (11.43%)  5 0/0  0 0/0  0 0/0  0
Haemorrhoids † 1  0/38 (0.00%)  0 2/35 (5.71%)  2 0/0  0 0/0  0 0/0  0
Nausea † 1  2/38 (5.26%)  2 1/35 (2.86%)  1 0/0  0 0/0  0 0/0  0
General disorders           
Influenza like illness † 1  2/38 (5.26%)  2 1/35 (2.86%)  1 0/0  0 0/0  0 0/0  0
Hepatobiliary disorders           
Hepatic steatosis † 1  0/38 (0.00%)  0 2/35 (5.71%)  2 0/0  0 0/0  0 0/0  0
Hyperbilirubinaemia † 1  3/38 (7.89%)  3 5/35 (14.29%)  8 0/0  0 0/0  0 0/0  0
Jaundice † 1  2/38 (5.26%)  2 4/35 (11.43%)  4 0/0  0 0/0  0 0/0  0
Ocular icterus † 1  2/38 (5.26%)  2 2/35 (5.71%)  3 0/0  0 0/0  0 0/0  0
Infections and infestations           
Cystitis † 1  2/38 (5.26%)  2 0/35 (0.00%)  0 0/0  0 0/0  0 0/0  0
Gastroenteritis † 1  3/38 (7.89%)  5 2/35 (5.71%)  2 0/0  0 0/0  0 0/0  0
Influenza † 1  3/38 (7.89%)  4 2/35 (5.71%)  2 0/0  0 0/0  0 0/0  0
Nasopharyngitis † 1  2/38 (5.26%)  2 1/35 (2.86%)  1 0/0  0 0/0  0 0/0  0
Pharyngitis † 1  2/38 (5.26%)  2 2/35 (5.71%)  4 0/0  0 0/0  0 0/0  0
Pharyngotonsillitis † 1  2/38 (5.26%)  2 1/35 (2.86%)  2 0/0  0 0/0  0 0/0  0
Pneumonia † 1  2/38 (5.26%)  2 0/35 (0.00%)  0 0/0  0 0/0  0 0/0  0
Tooth infection † 1  2/38 (5.26%)  2 0/35 (0.00%)  0 0/0  0 0/0  0 0/0  0
Upper respiratory tract infection † 1  2/38 (5.26%)  2 3/35 (8.57%)  4 0/0  0 0/0  0 0/0  0
Investigations           
Blood bilirubin unconjugated increased † 1  1/38 (2.63%)  1 2/35 (5.71%)  2 0/0  0 0/0  0 0/0  0
Metabolism and nutrition disorders           
Hypertriglyceridaemia † 1  2/38 (5.26%)  2 0/35 (0.00%)  0 0/0  0 0/0  0 0/0  0
Nervous system disorders           
Headache † 1  2/38 (5.26%)  2 1/35 (2.86%)  1 0/0  0 0/0  0 0/0  0
Somnolence † 1  2/38 (5.26%)  3 0/35 (0.00%)  0 0/0  0 0/0  0 0/0  0
Skin and subcutaneous tissue disorders           
Rash † 1  0/38 (0.00%)  0 2/35 (5.71%)  2 0/0  0 0/0  0 0/0  0
1
Term from vocabulary, MedDRA 19.1
†
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
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02386098     History of Changes
Other Study ID Numbers: 205892
AI468-048 ( Other Identifier: Bristol-Myers Squibb )
First Submitted: March 6, 2015
First Posted: March 11, 2015
Results First Submitted: June 4, 2018
Results First Posted: August 20, 2018
Last Update Posted: August 20, 2018