An Open-Label, Randomized Study Evaluating a Switch From a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors Regimen Plus Any Third Agent to Either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected Subjects With Safety and/or Tolerability Issues on Their Present Treatment Regimen.
Overview
- Phase
- Phase 4
- Intervention
- Atazanavir
- Conditions
- HIV, Combination Therapy
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 132
- Locations
- 9
- Primary Endpoint
- Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.
Detailed Description
Allocation: Randomized nonstratified Intervention model: Parallel versus comparator
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Atazanavir/Ritonavir + Raltegravir
Atazanavir + Ritonavir (heat-stable) + Raltegravir
Intervention: Atazanavir
Atazanavir/Ritonavir + Raltegravir
Atazanavir + Ritonavir (heat-stable) + Raltegravir
Intervention: Ritonavir (heat-stable)
Atazanavir/Ritonavir + Raltegravir
Atazanavir + Ritonavir (heat-stable) + Raltegravir
Intervention: Raltegravir
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
Reference Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine
Intervention: Atazanavir
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
Reference Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine
Intervention: Ritonavir (heat-stable)
Atazanavir/Ritonavir + Tenofovir/Emtricitabine
Reference Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine
Intervention: Tenofovir/Emtricitabine
Outcomes
Primary Outcomes
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
Time Frame: From Day 1 to Week 24
HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation. Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. RNA=ribonucleic acid; HIV=human immunodeficiency virus.
Secondary Outcomes
- Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24(Day 1 to Week 24)
- Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs(Day 1 to Week 48)
- Mean Changes in Fasting Lipid Levels From Baseline to Week 48(From Baseline to Week 48)
- Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48(From Day 1 to Week 48)
- Number of Participants With Virologic Rebound at Weeks 24 and 48(Day 1 to Weeks 28 and 48)
- Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48(Day 1 to Week 48)