Conditions: HIV Infections
Keywords: Treatment Naive HIV-1 infected treatment naive patients
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 252
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load \< 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous NRTI backbone.

Detailed description:

Arms:
arm 1: ATV 400 mg + 2 NRTIs (TBD), ATV once daily, NRTIs (TBD) arm 2: ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD) arm 3: ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)

Interventions: intervention 1: Atazanavir + 2 NRTIs intervention 2: Atazanavir + Ritonavir + 2 NRTIs
Intervention descriptions: intervention 1: Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs) intervention 2: Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)

Protocol document: