HIV Infections
Conditions
Brief summary
The purpose of this study is to evaluate whether the combination of BMS-955176 with atazanavir (ATV) \[with or without ritonavir (RTV)\] and dolutegravir (DTG) is efficacious, safe, and well-tolerated in HIV-1 infected treatment experienced adults.
Interventions
DRUGBMS-955176
HIV Maturation Inhibitor
DRUGAtazanavir (ATV)
Atazanavir
DRUGRitonavir (RTV)
Ritonavir
Dolutegravir
DRUGTenofovir (TDF)
Tenofovir
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and non-pregnant women, at least 18 years of age * Antiretroviral treatment-experienced, defined as having documented evidence of having failed 1 or 2 regimens that include 2 or 3 classes of antiretroviral (ARV) (with or without documented resistance) * CD4+ T-cell count \> 50 cells/mm3 * Screening genotype/phenotype indicating susceptibility to study drugs (unboosted ATV, FC \< 2.2; DTG; TDF)
Exclusion criteria
* Antiretroviral treatment-experienced adults who have failed \> 2 ARV regimens * Resistance or partial resistance to any study drug determined by tests at Screening * Historical or documented genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to ATV, TDF, RAL, Protease Inhibitors, and certain TAMs * Chronic hepatitis B virus (HBV)/ hepatitis C virus (HCV) * Blood tests that indicate normal liver function * Hemoglobin \< 8.0 g/dL, Platelets \< 50,000 cells/mm3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Week 24 | 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. |
| Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Week 24-Stage 2 | Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1 | Weeks 24, 48 and 96 | 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. |
| Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 2 | Weeks 24, 48 and 96 | 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. |
| Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 | Baseline and up to Week 72 | 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. |
| Change From Baseline in log10 HIV-1 RNA Over Time-Stage 2 | Baseline and up to Week 96 | This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1. |
| Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 | Baseline and up to Week 72 | 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. |
| Change From Baseline in CD4+ Cell Count Over Time-Stage 2 | Baseline and up to Week 96 | This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1. |
| Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 | Baseline and up to Week 72 | 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. |
| Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 2 | Baseline and up to Week 96 | This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1. |
| Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1 | Up to Week 96 | 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. |
| Number of Participants With SAEs and AELDs-Stage 2 | Up to Week 96 | This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1. |
| Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1 | Up to Week 96 | The occurrence of new AIDS defining events that is, Centers for Disease Control (CDC) Class C events in participants is presented. |
| Number of Participants With Occurrence of New AIDS Defining Events-Stage 2 | Up to Week 96 | This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1. |
| Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1 | Weeks 48 and 96 | 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. |
| Cmax for BMS-955176-Stage 2 | 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]) | 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 of Maximum Observed Plasma Concentration (Tmax) for BMS-955176-Stage 1 | 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]) | PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1. |
| Tmax for BMS-955176-Stage 2 | 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]) | 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). |
| Observed Plasma Concentration at the End of a Dosing Interval (Ctau) for BMS-955176-Stage 1 | 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]) | PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1. |
| Ctau for BMS-955176-Stage 2 | 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]) | 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). |
| Observed Pre-dose Plasma Concentration (C0) for BMS-955176-Stage 1 | 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]) | PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1. |
| C0 for BMS-955176-Stage 2 | 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]) | 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). |
| Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) for BMS-955176-Stage 1 | 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]) | PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1. |
| AUC(Tau) for BMS-955176-Stage 2 | 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]) | 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). |
| Number of Participants With Emergence of HIV Drug Resistance-Stage 1 | Up to Week 96 | 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. |
| Number of Participants With Emergence of HIV Drug Resistance-Stage 2 | Up to Week 96 | 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). |
| Maximum Observed Concentration (Cmax) for BMS-955176-Stage 1 | 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]) | 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. |
| Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 2 | Weeks 48 and 96 | 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. |
Countries
Argentina, Australia, Canada, Chile, Colombia, Mexico, Peru, Puerto Rico, Russia, South Africa, Taiwan, Thailand, United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 38 |
| 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. | 35 |
| 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. | 0 |
| 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. | 0 |
| 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. | 0 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Stage 1 (96 Weeks) | Adverse Event | 2 | 1 | 0 | 0 | 0 |
| Stage 1 (96 Weeks) | Lost to Follow-up | 2 | 2 | 0 | 0 | 0 |
| Stage 1 (96 Weeks) | Other | 1 | 0 | 0 | 0 | 0 |
| Stage 1 (96 Weeks) | Other: Administrative reason by sponsor | 30 | 29 | 0 | 0 | 0 |
| Stage 1 (96 Weeks) | Other: Breach of good clinical practice | 5 | 8 | 0 | 0 | 0 |
| Stage 1 (96 Weeks) | Other:Protocol defined stopping criteria | 0 | 2 | 0 | 0 | 0 |
| Stage 1 (96 Weeks) | Withdrawal by Subject | 3 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Total | Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD |
|---|---|---|---|
| Age, Continuous | 41.7 Years STANDARD_DEVIATION 12.06 | 40.7 Years STANDARD_DEVIATION 11.7 | 39.8 Years STANDARD_DEVIATION 11.45 |
| Race/Ethnicity, Customized Asian | 4 Participants | 8 Participants | 4 Participants |
| Race/Ethnicity, Customized Black/African American | 2 Participants | 8 Participants | 6 Participants |
| Race/Ethnicity, Customized Unknown | 12 Participants | 26 Participants | 14 Participants |
| Race/Ethnicity, Customized White | 17 Participants | 31 Participants | 14 Participants |
| Sex: Female, Male Female | 8 Participants | 15 Participants | 7 Participants |
| Sex: Female, Male Male | 27 Participants | 58 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 35 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 32 / 38 | 24 / 35 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 4 / 38 | 3 / 35 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Week 24
Population: mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
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.
Time frame: Week 24
Population: mITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 | 60.0 Percentage of participants |
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.
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])
Population: PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
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).
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])
Population: PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
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).
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])
Population: PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
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.
Time frame: 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.
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 109.7 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 | — |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 | Week 48; n=7, 9 | 175.1 Cells per microliter | Standard Deviation 64.64 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 | Week 4; n=37, 33 | 26.7 Cells per microliter | Standard Deviation 83.3 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 | Week 32; n=23, 22 | 122.1 Cells per microliter | Standard Deviation 122.65 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 | Week 8; n=36, 30 | 53.7 Cells per microliter | Standard Deviation 76.57 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 | Week 72; n=1, 1 | 171.0 Cells per microliter | — |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 | Week 12; n=35, 32 | 115.1 Cells per microliter | Standard Deviation 159.22 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 | Week 40; n=20, 15 | 137.1 Cells per microliter | Standard Deviation 122.36 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 | Week 16; n=34, 31 | 93.8 Cells per microliter | Standard Deviation 113.61 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 | Week 60; n=4, 2 | 158.5 Cells per microliter | Standard Deviation 79.9 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1 | Week 24; n=31, 28 | 109.5 Cells per microliter | Standard Deviation 124.35 |
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.
Time frame: 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.
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 1.513 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 | — |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 | Week 72; n=1, 1 | -5.713 log10 c/mL | — |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 | Week 2; n=10, 5 | -4.050 log10 c/mL | Standard Deviation 1.3413 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 | Week 4; n=37, 33 | -3.922 log10 c/mL | Standard Deviation 1.5241 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 | Week 8; n=37, 30 | -4.145 log10 c/mL | Standard Deviation 1.135 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 | Week 12; n=36, 32 | -4.113 log10 c/mL | Standard Deviation 1.128 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 | Week 16; n=34, 32 | -4.074 log10 c/mL | Standard Deviation 1.1437 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 | Week 24; n=32, 29 | -4.079 log10 c/mL | Standard Deviation 1.1754 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 | Week 32; n=23, 23 | -3.364 log10 c/mL | Standard Deviation 2.7492 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 | Week 40; n=21, 15 | -4.400 log10 c/mL | Standard Deviation 1.0572 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 | Week 48; n=8, 9 | -4.680 log10 c/mL | Standard Deviation 1.0607 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1 | Week 60; n=4, 3 | -4.977 log10 c/mL | Standard Deviation 1.4043 |
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 3.76 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 3.46 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 | Week 72; n=1, 1 | 12.50 Percentage of CD4+ cells | — |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 | Week 72; n=1, 1 | 10.70 Percentage of CD4+ cells | — |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 | Week 4; n=37, 33 | 1.82 Percentage of CD4+ cells | Standard Deviation 2.152 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 | Week 8; n=36, 30 | 1.69 Percentage of CD4+ cells | Standard Deviation 2.49 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 | Week 12; n=35, 32 | 2.88 Percentage of CD4+ cells | Standard Deviation 3.084 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 | Week 16; n=34, 31 | 3.66 Percentage of CD4+ cells | Standard Deviation 3.155 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 | Week 32; n=23, 22 | 4.81 Percentage of CD4+ cells | Standard Deviation 4.237 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 3.318 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 | Week 48; n=7, 9 | 7.16 Percentage of CD4+ cells | Standard Deviation 3.777 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 | Week 60; n=4, 2 | 10.05 Percentage of CD4+ cells | Standard Deviation 2.616 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1 | Week 24; n=31, 28 | 4.72 Percentage of CD4+ cells | Standard Deviation 3.315 |
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.
Time frame: 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.
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).
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])
Population: PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
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).
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])
Population: PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
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.
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])
Population: PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
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.
Time frame: Up to Week 96
Population: mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
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).
Time frame: Up to Week 96
Population: mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
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.
Time frame: Up to Week 96
Population: mITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1 | 1 Participants |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1 | 0 Participants |
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.
Time frame: Up to Week 96
Population: mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
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.
Time frame: Up to Week 96
Population: mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
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.
Time frame: Up to Week 96
Population: mITT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1 | SAEs | 4 Participants |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1 | AELD | 2 Participants |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1 | SAEs | 3 Participants |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1 | AELD | 1 Participants |
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.
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])
Population: PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
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.
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])
Population: PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
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.
Time frame: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1 | Week 24; n=32, 29 | 89.7 Percentage of participants |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
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.
Time frame: Weeks 24, 48 and 96
Population: mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.
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.
Time frame: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stage 1: BMS-955176 120 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | 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 |
| Stage 1: TDF 300 mg QD+ATV/r 300/100 mg QD+DTG 50 mg QD | Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1 | Week 48; n=8, 9 | 66.7 Percentage of participants |
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.
Time frame: Weeks 48 and 96
Population: mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.
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.
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])
Population: PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.
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).
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])
Population: PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.