Trial Outcomes & Findings for Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults (NCT NCT02386098)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

86 participants

Primary outcome timeframe

Week 24

Results posted on

2018-08-20

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD 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.	Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD 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.
Stage 1 (96 Weeks) STARTED	43	43
Stage 1 (96 Weeks) COMPLETED	0	0
Stage 1 (96 Weeks) NOT COMPLETED	43	43
Stage 2 (96 Weeks) STARTED	0	0
Stage 2 (96 Weeks) COMPLETED	0	0
Stage 2 (96 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD 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.	Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD 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.
Stage 1 (96 Weeks) Other: Administrative reason by sponsor	30	29
Stage 1 (96 Weeks) Adverse Event	2	1
Stage 1 (96 Weeks) Lost to Follow-up	2	2
Stage 1 (96 Weeks) Other:Protocol defined stopping criteria	0	2
Stage 1 (96 Weeks) Withdrawal by Subject	3	1
Stage 1 (96 Weeks) Other	1	0
Stage 1 (96 Weeks) Other: Breach of good clinical practice	5	8

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD n=38 Participants 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.	Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD n=35 Participants 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.	Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD 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.	Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD 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.	Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD 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 n=73 Participants Total of all reporting groups
Age, Continuous	39.8 Years STANDARD_DEVIATION 11.45 • n=5 Participants	41.7 Years STANDARD_DEVIATION 12.06 • n=7 Participants	—	—	—	40.7 Years STANDARD_DEVIATION 11.70 • n=8 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	—	—	—	15 Participants n=8 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	27 Participants n=7 Participants	—	—	—	58 Participants n=8 Participants
Race/Ethnicity, Customized White	14 Participants n=5 Participants	17 Participants n=7 Participants	—	—	—	31 Participants n=8 Participants
Race/Ethnicity, Customized Black/African American	6 Participants n=5 Participants	2 Participants n=7 Participants	—	—	—	8 Participants n=8 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	—	—	—	8 Participants n=8 Participants
Race/Ethnicity, Customized Unknown	14 Participants n=5 Participants	12 Participants n=7 Participants	—	—	—	26 Participants n=8 Participants

PRIMARY outcome

Timeframe: Week 24

Population: mITT Population

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.

Outcome measures

Outcome measures
Measure	Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD n=38 Participants 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.	Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD n=35 Participants 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.	Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD 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.
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	73.7 Percentage of participants Interval 56.9 to 86.6	60.0 Percentage of participants Interval 42.1 to 76.1	—

PRIMARY outcome

Timeframe: Week 24

Population: mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weeks 48 and 96

Population: mITT Population (observed). Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

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.

Outcome measures

Outcome measures
Measure	Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD n=38 Participants 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.	Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD n=35 Participants 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.	Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD 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.
Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1 Week 48; n=8, 9	75.0 Percentage of participants Interval 34.9 to 96.8	66.7 Percentage of participants Interval 29.9 to 92.5	—

SECONDARY outcome

Timeframe: Weeks 48 and 96

Population: mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weeks 24, 48 and 96

Population: mITT Population (observed). Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles)

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.

Outcome measures

Outcome measures
Measure	Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD n=38 Participants 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.	Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD n=35 Participants 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.	Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD 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.
Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1 Week 24; n=32, 29	93.8 Percentage of participants Interval 79.2 to 99.2	89.7 Percentage of participants Interval 72.6 to 97.8	—
Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1 Week 48; n=8, 9	100 Percentage of participants Interval 63.1 to 100.0	100 Percentage of participants Interval 66.4 to 100.0	—

SECONDARY outcome

Timeframe: Weeks 24, 48 and 96

Population: mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to Week 72

Population: mITT Population (observed). Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles)

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.

Outcome measures

Outcome measures
Measure	Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD n=38 Participants 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.	Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD n=35 Participants 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.	Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD 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.
Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 Week 2; n=10, 5	-4.232 log10 c/mL Standard Deviation 0.8779	-4.050 log10 c/mL Standard Deviation 1.3413	—
Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 Week 8; n=37, 30	-4.103 log10 c/mL Standard Deviation 1.8696	-4.145 log10 c/mL Standard Deviation 1.1350	—
Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 Week 24; n=32, 29	-4.220 log10 c/mL Standard Deviation 1.5130	-4.079 log10 c/mL Standard Deviation 1.1754	—
Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 Week 72; n=1, 1	-3.326 log10 c/mL Standard Deviation NA The standard deviation could not be calculated as a single participant was analyzed at the specified time point.	-5.713 log10 c/mL Standard Deviation NA The standard deviation could not be calculated as a single participant was analyzed at the specified time point.	—
Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 Week 4; n=37, 33	-4.400 log10 c/mL Standard Deviation 0.8983	-3.922 log10 c/mL Standard Deviation 1.5241	—
Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 Week 12; n=36, 32	-4.394 log10 c/mL Standard Deviation 0.9011	-4.113 log10 c/mL Standard Deviation 1.1280	—
Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 Week 16; n=34, 32	-4.402 log10 c/mL Standard Deviation 0.9267	-4.074 log10 c/mL Standard Deviation 1.1437	—
Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 Week 32; n=23, 23	-4.381 log10 c/mL Standard Deviation 1.0267	-3.364 log10 c/mL Standard Deviation 2.7492	—
Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 Week 40; n=21, 15	-4.366 log10 c/mL Standard Deviation 1.0553	-4.400 log10 c/mL Standard Deviation 1.0572	—
Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 Week 48; n=8, 9	-4.508 log10 c/mL Standard Deviation 1.1333	-4.680 log10 c/mL Standard Deviation 1.0607	—
Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 Week 60; n=4, 3	-5.037 log10 c/mL Standard Deviation 1.2665	-4.977 log10 c/mL Standard Deviation 1.4043	—

SECONDARY outcome

Timeframe: Baseline and up to Week 96

Population: mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.

This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to Week 72

Population: mITT Population (observed). Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)

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.

Outcome measures

Outcome measures
Measure	Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD n=38 Participants 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.	Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD n=35 Participants 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.	Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD 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.
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 Week 4; n=37, 33	57.6 Cells per microliter Standard Deviation 93.54	26.7 Cells per microliter Standard Deviation 83.30	—
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 Week 8; n=36, 30	77.6 Cells per microliter Standard Deviation 130.59	53.7 Cells per microliter Standard Deviation 76.57	—
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 Week 12; n=35, 32	90.4 Cells per microliter Standard Deviation 190.31	115.1 Cells per microliter Standard Deviation 159.22	—
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 Week 16; n=34, 31	83.2 Cells per microliter Standard Deviation 116.78	93.8 Cells per microliter Standard Deviation 113.61	—
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 Week 24; n=31, 28	127.2 Cells per microliter Standard Deviation 146.37	109.5 Cells per microliter Standard Deviation 124.35	—
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 Week 32; n=23, 22	90.0 Cells per microliter Standard Deviation 109.70	122.1 Cells per microliter Standard Deviation 122.65	—
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 Week 40; n=20, 15	139.5 Cells per microliter Standard Deviation 82.72	137.1 Cells per microliter Standard Deviation 122.36	—
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 Week 48; n=7, 9	125.0 Cells per microliter Standard Deviation 88.72	175.1 Cells per microliter Standard Deviation 64.64	—
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 Week 60; n=4, 2	127.0 Cells per microliter Standard Deviation 99.39	158.5 Cells per microliter Standard Deviation 79.90	—
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 Week 72; n=1, 1	0.0 Cells per microliter Standard Deviation NA The standard deviation could not be calculated as a single participant was analyzed at the specified time point.	171.0 Cells per microliter Standard Deviation NA The standard deviation could not be calculated as a single participant was analyzed at the specified time point.	—

SECONDARY outcome

Timeframe: Baseline and up to Week 96

Population: mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.

This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and up to Week 72

Population: mITT Population (observed). Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).

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.

Outcome measures

Outcome measures
Measure	Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD n=38 Participants 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.	Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD n=35 Participants 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.	Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD 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.
Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 Week 4; n=37, 33	1.94 Percentage of CD4+ cells Standard Deviation 2.701	1.82 Percentage of CD4+ cells Standard Deviation 2.152	—
Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 Week 8; n=36, 30	1.80 Percentage of CD4+ cells Standard Deviation 2.495	1.69 Percentage of CD4+ cells Standard Deviation 2.490	—
Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 Week 12; n=35, 32	3.41 Percentage of CD4+ cells Standard Deviation 3.760	2.88 Percentage of CD4+ cells Standard Deviation 3.084	—
Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 Week 16; n=34, 31	3.14 Percentage of CD4+ cells Standard Deviation 3.486	3.66 Percentage of CD4+ cells Standard Deviation 3.155	—
Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 Week 24; n=31, 28	4.71 Percentage of CD4+ cells Standard Deviation 2.914	4.72 Percentage of CD4+ cells Standard Deviation 3.315	—
Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 Week 32; n=23, 22	4.13 Percentage of CD4+ cells Standard Deviation 3.671	4.81 Percentage of CD4+ cells Standard Deviation 4.237	—
Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 Week 40; n=20, 15	5.38 Percentage of CD4+ cells Standard Deviation 3.460	5.38 Percentage of CD4+ cells Standard Deviation 3.318	—
Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 Week 48; n=7, 9	7.09 Percentage of CD4+ cells Standard Deviation 4.271	7.16 Percentage of CD4+ cells Standard Deviation 3.777	—
Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 Week 60; n=4, 2	7.95 Percentage of CD4+ cells Standard Deviation 2.121	10.05 Percentage of CD4+ cells Standard Deviation 2.616	—
Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 Week 72; n=1, 1	12.50 Percentage of CD4+ cells Standard Deviation NA The standard deviation could not be calculated as a single participant was analyzed at the specified time point.	10.70 Percentage of CD4+ cells Standard Deviation NA The standard deviation could not be calculated as a single participant was analyzed at the specified time point.	—

SECONDARY outcome

Timeframe: Baseline and up to Week 96

Population: mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.

This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 96

Population: mITT Population

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.

Outcome measures

Outcome measures
Measure	Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD n=38 Participants 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.	Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD n=35 Participants 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.	Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD 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.
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1 SAEs	4 Participants	3 Participants	—
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1 AELD	2 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Up to Week 96

Population: mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.

This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Week 96

Population: mITT Population

The occurrence of new AIDS defining events that is, Centers for Disease Control (CDC) Class C events in participants is presented.

Outcome measures

Outcome measures
Measure	Stage 2: BMS-955176 120 mg QD+ATV 400 mg QD+DTG 50 mg QD n=38 Participants 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.	Stage 2: BMS-955176 180 mg QD+ATV 400 mg QD+DTG 50 mg QD n=35 Participants 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.	Stage 2: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD 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.
Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Up to Week 96

Population: mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.

This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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])