| Primary | 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 | 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. | | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00073.7(56.9 to 86.6)
- OG00160.0(42.1 to 76.1)
|
|
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| Primary | Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Week 24-Stage 2 | 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. | mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1 | 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. | mITT Population (observed). Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Weeks 48 and 96 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | |
|
| Secondary | Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 2 | 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. | mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | Weeks 48 and 96 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1 | 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. | mITT Population (observed). Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles) | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Weeks 24, 48 and 96 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD |
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| Secondary | Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 2 | 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. | mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | Weeks 24, 48 and 96 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 | 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. | mITT Population (observed). Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles) | Posted | | Mean | Standard Deviation | log10 c/mL | | Baseline and up to Week 72 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | |
|
| Secondary | Change From Baseline in log10 HIV-1 RNA Over Time-Stage 2 | This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1. | mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | Baseline and up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 | 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. | mITT Population (observed). Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles) | Posted | | Mean | Standard Deviation | Cells per microliter | | Baseline and up to Week 72 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Change From Baseline in CD4+ Cell Count Over Time-Stage 2 | This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1. | mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | Baseline and up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 | 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. | mITT Population (observed). Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles). | Posted | | Mean | Standard Deviation | Percentage of CD4+ cells | | Baseline and up to Week 72 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 2 | This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1. | mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | Baseline and up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1 | 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. | | Posted | | Count of Participants | | Participants | | Up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Number of Participants With SAEs and AELDs-Stage 2 | This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1. | mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | Up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1 | The occurrence of new AIDS defining events that is, Centers for Disease Control (CDC) Class C events in participants is presented. | | Posted | | Count of Participants | | Participants | | Up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Number of Participants With Occurrence of New AIDS Defining Events-Stage 2 | This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1. | mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | Up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Maximum Observed Concentration (Cmax) for BMS-955176-Stage 1 | 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. | PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | 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]) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Cmax for BMS-955176-Stage 2 | 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). | PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | 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]) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Time of Maximum Observed Plasma Concentration (Tmax) for BMS-955176-Stage 1 | PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1. | PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | 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]) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Tmax for BMS-955176-Stage 2 | 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). | PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | 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]) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Observed Plasma Concentration at the End of a Dosing Interval (Ctau) for BMS-955176-Stage 1 | PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1. | PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | 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]) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Ctau for BMS-955176-Stage 2 | 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). | PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | 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]) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Observed Pre-dose Plasma Concentration (C0) for BMS-955176-Stage 1 | PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1. | PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | 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]) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | C0 for BMS-955176-Stage 2 | 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). | PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | 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]) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) for BMS-955176-Stage 1 | PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1. | PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | 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]) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | AUC(Tau) for BMS-955176-Stage 2 | 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). | PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | 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]) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Number of Participants With Emergence of HIV Drug Resistance-Stage 1 | 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. | mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | Up to Week 96 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants With Emergence of HIV Drug Resistance-Stage 2 | 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). | mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study. | Posted | | | | | | Up to Week 96 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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