At a glance
ClinicalIndex Comparison Record- ✓Virologic failure to 2 or more HAART regimens including at least one drug from each class (PI, NNRTI, NRTI)
- ✓Currently on failing HAART with viral load ≥1,000 c/mL on two measurements (≤4 weeks apart)
- ✓CD4 cell count ≥50 cells/mm³ within 4 weeks prior to randomization
- ✓Age ≥16 years (or minimum age per local regulations)
- ✕Prior use of atazanavir, tenofovir, or lopinavir/ritonavir for ≥3 days; prior saquinavir use requires phenotypic sensitivity
- ✕Current regimen must have run for ≥8 weeks and must not include both a PI and NNRTI simultaneously
- ✕Newly diagnosed HIV-related opportunistic infection or acute medical condition requiring therapy at enrollment
- ✕Acute hepatitis within 30 days prior to study entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Open Label Atazanavir (BMS-232632) in Combination With Ritonavir or Saquinavir, and Lopinavir/Ritonavir, Each With Tenofovir and a Nucleoside in Subjects With HIV
In Brief
A Phase 3 clinical trial evaluating Atazanavir + ritonavir + tenofovir + nucleoside, Atazanavir + saquinavir + tenofovir + nucleoside, and 1 other intervention for HIV Infections. Completed, enrolled 571 participants across 29 sites.
Detailed Summary
The purpose of this study is to learn how well atazanavir (ATV) works in combination with ritonavir (RTV) or saquinavir (SQV) with tenofovir (TDF) and a nucleoside to reduce the viral load of treatment experienced subjects with human immunodeficiency virus (HIV). There is a comparison arm with lopinavir (LPV)/RTV and TDF and a nucleoside.
Study Details
Timeline
Interventions
Active Comparator, Capsules, tablets, Oral
Active Comparator, Capsules, tablets, Oral
Active Comparator, Capsules, tablets, Oral