Conditions: HIV, Combination Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 132
Healthy volunteers: no

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

Arms:
arm 1: Atazanavir + Ritonavir (heat-stable) + Raltegravir arm 2: Reference

Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine

Interventions: intervention 1: Atazanavir intervention 2: Ritonavir (heat-stable) intervention 3: Raltegravir intervention 4: Tenofovir/Emtricitabine
Intervention descriptions: intervention 1: Capsules, Oral, 300mg, Once daily, 48 weeks intervention 2: Tablets, Oral, 100 mg, Once daily, 48 weeks intervention 3: Tablets, Oral, 400 mg, Twice daily, 48 weeks intervention 4: Tablets, Oral, 300/200 mg, Once daily, 48 weeks

Protocol document: