Conditions: HIV Infections
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1068
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR) in ARV therapy naïve HIV-1 infected patients after 48 weeks of treatment. Secondary objectives are to evaluate safety and pharmacokinetics of NVP XR and NVP IR.

Detailed description:

Arms:
arm 1: 400 mg QD arm 2: 200 mg BID

Interventions: intervention 1: nevirapine IR intervention 2: nevirapine XR
Intervention descriptions: intervention 1: 200 mg BID intervention 2: 400 mg QD

Protocol document: