Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients
- Conditions
- HIV, Combination Therapy
- Interventions
- Registration Number
- NCT01332227
- Lead Sponsor
- Bristol-Myers Squibb
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atazanavir/Ritonavir + Tenofovir/Emtricitabine Ritonavir (heat-stable) Reference Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine Atazanavir/Ritonavir + Raltegravir Atazanavir Atazanavir + Ritonavir (heat-stable) + Raltegravir Atazanavir/Ritonavir + Tenofovir/Emtricitabine Atazanavir Reference Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine Atazanavir/Ritonavir + Raltegravir Ritonavir (heat-stable) Atazanavir + Ritonavir (heat-stable) + Raltegravir Atazanavir/Ritonavir + Tenofovir/Emtricitabine Tenofovir/Emtricitabine Reference Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine Atazanavir/Ritonavir + Raltegravir Raltegravir Atazanavir + Ritonavir (heat-stable) + Raltegravir
- Primary Outcome Measures
Name Time Method Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24 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 Outcome Measures
Name Time Method 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 Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients
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 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.
Mean Changes in Fasting Lipid Levels From Baseline to Week 48 From Baseline to Week 48 LD=low-density lipoprotein; HDL=high-density lipoprotein.
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48 From Day 1 to Week 48 Percentages of patients with HIV-1 RNA levels \<40 c/mL were summarized at each scheduled visit. Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals.
Number of Participants With Virologic Rebound at Weeks 24 and 48 Day 1 to Weeks 28 and 48 Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates.
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 Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients
Trial Locations
- Locations (9)
Health For Life Clinic Pllc
🇺🇸Little Rock, Arkansas, United States
Eisenhower Medical Center
🇺🇸Palm Springs, California, United States
Consultive Medicine
🇺🇸Daytona Beach, Florida, United States
Orange County Health Dept.
🇺🇸Orlando, Florida, United States
The Research Institute
🇺🇸Springfield, Massachusetts, United States
Aids Care
🇺🇸Rochester, New York, United States
Local Institution
🇬🇧Sheffield, United Kingdom
Metropolis Medical Pc
🇺🇸San Francisco, California, United States
Triple O Medical Services, P.A.
🇺🇸West Palm Beach, Florida, United States