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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02386098
Registration number
NCT02386098
Ethics application status
Date submitted
6/03/2015
Date registered
11/03/2015
Date last updated
20/08/2018
Titles & IDs
Public title
Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults
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Scientific title
A Phase 2b Randomized, Active-Controlled, Staged, Open-Label Trial to Investigate Safety and Efficacy of BMS-955176/GSK3532795 in Combination With Dolutegravir and Atazanavir (With or Without Ritonavir) in Treatment-Experienced HIV-1 Infected Adults
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Secondary ID [1]
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0
AI468-048
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Secondary ID [2]
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205892
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV Infections
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0
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Condition category
Condition code
Infection
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0
0
0
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Acquired immune deficiency syndrome (AIDS / HIV)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BMS-955176
Treatment: Drugs - Atazanavir (ATV)
Treatment: Drugs - Ritonavir (RTV)
Treatment: Drugs - Dolutegravir (DTG)
Treatment: Drugs - Tenofovir (TDF)
Experimental: Arm 1: BMS-955176 + ATV + RTV + DTG - BMS-955176 at 120 mg tablet per day + Atazanavir boosted with ritonavir (ATV/r) 300/100 mg tablets per day + DTG 50 mg tablet per day, orally
Other: Arm 2: TDF + ATV + RTV + DTG - TDF 300 mg tablet per day + ATV/r at 300/100 mg tablets per day + DTG 50 mg per day, orally
Experimental: Arm 3: BMS-955176 + ATV + DTG - BMS-955176 at 120 mg tablet per day + ATV at 400 mg tablet per day + DTG at 50 mg tablet per day, orally
Experimental: Arm 4: BMS-955176 + ATV + DTG - BMS-955176 at 180 mg tablet per day + ATV at 400 mg tablet per day + DTG at 50 mg tablet per day, orally
Other: Arm 5: TDF + ATV + RTV + DTG - TDF 300 mg tablet per day + ATV/r at 300/100 mg tablets per day + DTG 50 mg per day, orally
Treatment: Drugs: BMS-955176
HIV Maturation Inhibitor
Treatment: Drugs: Atazanavir (ATV)
Atazanavir
Treatment: Drugs: Ritonavir (RTV)
Ritonavir
Treatment: Drugs: Dolutegravir (DTG)
Dolutegravir
Treatment: Drugs: Tenofovir (TDF)
Tenofovir
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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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.
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Timepoint [1]
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Week 24
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Primary outcome [2]
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Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Week 24-Stage 2
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Assessment method [2]
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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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Timepoint [2]
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Week 24
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Secondary outcome [1]
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Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1
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Assessment method [1]
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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.
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Timepoint [1]
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Weeks 48 and 96
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Secondary outcome [2]
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Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 2
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Assessment method [2]
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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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Timepoint [2]
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Weeks 48 and 96
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Secondary outcome [3]
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Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1
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Assessment method [3]
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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.
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Timepoint [3]
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Weeks 24, 48 and 96
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Secondary outcome [4]
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Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 2
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Assessment method [4]
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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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Timepoint [4]
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0
Weeks 24, 48 and 96
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Secondary outcome [5]
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Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline and up to Week 72
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Secondary outcome [6]
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Change From Baseline in log10 HIV-1 RNA Over Time-Stage 2
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Assessment method [6]
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This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.
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Timepoint [6]
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Baseline and up to Week 96
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Secondary outcome [7]
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Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1
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Assessment method [7]
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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.
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Timepoint [7]
0
0
Baseline and up to Week 72
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Secondary outcome [8]
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Change From Baseline in CD4+ Cell Count Over Time-Stage 2
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Assessment method [8]
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0
This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.
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Timepoint [8]
0
0
Baseline and up to Week 96
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Secondary outcome [9]
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Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1
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Assessment method [9]
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0
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.
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Timepoint [9]
0
0
Baseline and up to Week 72
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Secondary outcome [10]
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0
Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 2
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Assessment method [10]
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This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.
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Timepoint [10]
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Baseline and up to Week 96
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Secondary outcome [11]
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Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1
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Assessment method [11]
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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.
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Timepoint [11]
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Up to Week 96
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Secondary outcome [12]
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Number of Participants With SAEs and AELDs-Stage 2
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Assessment method [12]
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This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.
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Timepoint [12]
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Up to Week 96
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Secondary outcome [13]
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Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1
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Assessment method [13]
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The occurrence of new AIDS defining events that is, Centers for Disease Control (CDC) Class C events in participants is presented.
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Timepoint [13]
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Up to Week 96
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Secondary outcome [14]
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0
Number of Participants With Occurrence of New AIDS Defining Events-Stage 2
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Assessment method [14]
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0
This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.
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Timepoint [14]
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0
Up to Week 96
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Secondary outcome [15]
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0
Maximum Observed Concentration (Cmax) for BMS-955176-Stage 1
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Assessment method [15]
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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.
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Timepoint [15]
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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])
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Secondary outcome [16]
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Cmax for BMS-955176-Stage 2
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Assessment method [16]
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0
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).
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Timepoint [16]
0
0
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])
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Secondary outcome [17]
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Time of Maximum Observed Plasma Concentration (Tmax) for BMS-955176-Stage 1
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Assessment method [17]
0
0
PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.
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Timepoint [17]
0
0
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])
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Secondary outcome [18]
0
0
Tmax for BMS-955176-Stage 2
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Assessment method [18]
0
0
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).
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Timepoint [18]
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0
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])
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Secondary outcome [19]
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Observed Plasma Concentration at the End of a Dosing Interval (Ctau) for BMS-955176-Stage 1
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Assessment method [19]
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PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.
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Timepoint [19]
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0
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])
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Secondary outcome [20]
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0
Ctau for BMS-955176-Stage 2
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Assessment method [20]
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0
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).
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Timepoint [20]
0
0
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])
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Secondary outcome [21]
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0
Observed Pre-dose Plasma Concentration (C0) for BMS-955176-Stage 1
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Assessment method [21]
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0
PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.
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Timepoint [21]
0
0
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])
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Secondary outcome [22]
0
0
C0 for BMS-955176-Stage 2
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Assessment method [22]
0
0
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).
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Timepoint [22]
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0
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])
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Secondary outcome [23]
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Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) for BMS-955176-Stage 1
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Assessment method [23]
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0
PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.
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Timepoint [23]
0
0
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])
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Secondary outcome [24]
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0
AUC(Tau) for BMS-955176-Stage 2
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Assessment method [24]
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0
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).
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Timepoint [24]
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0
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])
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Secondary outcome [25]
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Number of Participants With Emergence of HIV Drug Resistance-Stage 1
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Assessment method [25]
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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.
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Timepoint [25]
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0
Up to Week 96
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Secondary outcome [26]
0
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Number of Participants With Emergence of HIV Drug Resistance-Stage 2
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Assessment method [26]
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0
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).
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Timepoint [26]
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Up to Week 96
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/07/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/06/2017
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Sample size
Target
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Accrual to date
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Final
86
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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GSK Investigational Site - Darlinghurst, Sydney
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Recruitment hospital [2]
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GSK Investigational Site - Darlinghurst
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Recruitment hospital [3]
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0
GSK Investigational Site - Sydney
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Recruitment postcode(s) [1]
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0
2010 - Darlinghurst, Sydney
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Recruitment postcode(s) [2]
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0
2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2010 - Sydney
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Connecticut
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Georgia
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Indiana
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Country [6]
0
0
United States of America
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State/province [6]
0
0
New York
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Oklahoma
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Texas
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Country [9]
0
0
Argentina
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State/province [9]
0
0
Buenos Aires
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Country [10]
0
0
Argentina
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State/province [10]
0
0
Santa Fe
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Country [11]
0
0
Argentina
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State/province [11]
0
0
Córdoba
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Country [12]
0
0
Argentina
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State/province [12]
0
0
Mar del Plata
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Country [13]
0
0
Canada
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State/province [13]
0
0
British Columbia
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Country [14]
0
0
Canada
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State/province [14]
0
0
Manitoba
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Country [15]
0
0
Canada
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State/province [15]
0
0
Ontario
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Country [16]
0
0
Canada
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State/province [16]
0
0
Quebec
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Country [17]
0
0
Chile
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State/province [17]
0
0
Región Metro De Santiago
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Country [18]
0
0
Chile
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State/province [18]
0
0
Providencia, Santiago De Chile
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Country [19]
0
0
Chile
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State/province [19]
0
0
Santiago
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Country [20]
0
0
Colombia
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State/province [20]
0
0
Barranquilla
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Country [21]
0
0
Colombia
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State/province [21]
0
0
Bogota
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Country [22]
0
0
Colombia
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State/province [22]
0
0
Bogotá
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Country [23]
0
0
Colombia
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State/province [23]
0
0
Cali
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Country [24]
0
0
Mexico
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State/province [24]
0
0
Chihuahua
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Country [25]
0
0
Mexico
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State/province [25]
0
0
Jalisco
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Country [26]
0
0
Mexico
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State/province [26]
0
0
DF
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Country [27]
0
0
Mexico
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State/province [27]
0
0
Distrito Federal
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Country [28]
0
0
Mexico
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State/province [28]
0
0
Mexico City
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Country [29]
0
0
Mexico
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State/province [29]
0
0
Oaxaca
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Country [30]
0
0
Peru
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State/province [30]
0
0
Lima
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Country [31]
0
0
Puerto Rico
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State/province [31]
0
0
San Juan
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Country [32]
0
0
Russian Federation
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State/province [32]
0
0
Ekaterinburg
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Country [33]
0
0
Russian Federation
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State/province [33]
0
0
Irkutsk
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Country [34]
0
0
Russian Federation
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State/province [34]
0
0
Krasnodar
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Country [35]
0
0
Russian Federation
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State/province [35]
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0
Moscow
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Country [36]
0
0
Russian Federation
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State/province [36]
0
0
St. Petersburg
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Country [37]
0
0
South Africa
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State/province [37]
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0
Eastern Cape
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Country [38]
0
0
South Africa
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State/province [38]
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0
Free State
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Country [39]
0
0
South Africa
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State/province [39]
0
0
Tembisa
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Country [40]
0
0
South Africa
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State/province [40]
0
0
Westdene
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Country [41]
0
0
Taiwan
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State/province [41]
0
0
Kaohsiung
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Country [42]
0
0
Taiwan
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State/province [42]
0
0
Taipei
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Country [43]
0
0
Thailand
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State/province [43]
0
0
Bangkok
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ViiV Healthcare
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
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0
GlaxoSmithKline
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02386098
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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ViiV Healthcare
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/98/NCT02386098/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/98/NCT02386098/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02386098
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