NCT01605084
Withdrawn
Phase 3
An Open-Label Phase 3B Study in HIV-Infected Individuals With Viremia on or After Their First-Line Non-Nucleoside Reverse Transcriptase Inhibitor or Integrase Inhibitor-Based Regimen and Starting a Second-Line Regimen Consisting of ATV/RTV or DRV/RTV With an Optimized NRTI Backbone
ConditionsHIV
Overview
- Phase
- Phase 3
- Intervention
- Atazanavir
- Conditions
- HIV
- Sponsor
- Bristol-Myers Squibb
- Locations
- 12
- Primary Endpoint
- Proportion of subjects with Human immunodeficiency virus 1 (HIV-1) Ribonucleic Acid (RNA) < 50 c/mL
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to determine the proportion of subjects with HIV-1 RNA < 50 c/mL at Week 48 in patients who failed their first line therapy containing a non-nucleoside reverse transcriptase inhibitor (NNRTI) or an integrase inhibitor
Detailed Description
Allocation: Randomization will be stratified * ATV = Atazanavir * DRV = Darunavir * RTV = Ritonavir
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm 1: ATV/RTV 300/100 mg QD + optimized NRTI backbone
Intervention: Atazanavir
Arm 1: ATV/RTV 300/100 mg QD + optimized NRTI backbone
Intervention: Ritonavir
Arm 1: ATV/RTV 300/100 mg QD + optimized NRTI backbone
Intervention: Optimized NRTI backbone
Arm 2: DRV/RTV 800/100 mg QD + optimized NRTI backbone
Intervention: Darunavir
Arm 2: DRV/RTV 800/100 mg QD + optimized NRTI backbone
Intervention: Ritonavir
Arm 2: DRV/RTV 800/100 mg QD + optimized NRTI backbone
Intervention: Optimized NRTI backbone
Outcomes
Primary Outcomes
Proportion of subjects with Human immunodeficiency virus 1 (HIV-1) Ribonucleic Acid (RNA) < 50 c/mL
Time Frame: At Week 48
Secondary Outcomes
- Change from baseline in CD4 cell count(Baseline (Week 0) and at week 48)
- Incidence rates of serious adverse event (SAEs) and adverse events (AEs) leading to discontinuation(up to week 48)
- Proportion of subjects with HIV-1 RNA < 50 c/mL(At week 24)
- Incidence rates of antiretroviral resistance measured by newly emergent genotypic substitutions and phenotypic resistance to study drugs for virologic failure(up to week 48)
- Proportion of subjects with HIV-1 RNA < 50 c/mL at Week 48 by baseline M184V presence or absence(Week 48)
Study Sites (12)
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