Conditions: HIV Infections
Keywords: HIV Treatment Naive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1057
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety, tolerability and antiviral effects of atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV. A combination drug containing tenofovir (TDF) and emtricitabine (FTC) will also be taken by participants in both arms.

Detailed description:

Arms:
arm 1: Participants were administered an oral dose of ATV 300 mg and RTV 100 mg once daily along with food on a background of fixed dose combination TDF 300 mg plus FTC 200 mg (TDF/FTC) once daily. Doses of ATV and RTV were taken 24 hours apart at the same time as the background TDF/FTC, up to 96 Weeks. arm 2: Participants were administered an oral dose of LPV 400 mg and RTV 100 mg once daily along with food on a background of fixed dose combination TDF 300 mg plus FTC 200 mg (TDF/FTC) once daily. Doses of LPV and RTV were taken 24 hours apart at the same time as the background TDF/FTC, up to 96 Weeks.

Interventions: intervention 1: ATV intervention 2: RTV intervention 3: Tenofovi-Emtricitabine (TDF/FTC) tablet intervention 4: LPV
Intervention descriptions: intervention 1: 300mg Oral capsules for 96 weeks intervention 2: 100mg Oral Capsules for 96 weeks intervention 3: One tablet with 300 mg - 200 mg once a day for 96 weeks. intervention 4: 400 mg (3 133mg capsules) BID for 96 weeks

Protocol document: