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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
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
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
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
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.
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Dolutegravir
Tenofovir
GSK Investigational Site
Beverly Hills, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Palm Springs, California, United States
GSK Investigational Site
New Haven, Connecticut, United States
GSK Investigational Site
DeLand, Florida, United States
GSK Investigational Site
Fort Lauderdale, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
...and 54 more locations
Time frame: Weeks 48 and 96
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
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
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
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
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
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
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
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
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
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
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
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
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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
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