Conditions: Cardiovascular Disease
Keywords: endothelium inflammation oxidative stress HIV-1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: yes

Brief summary:
The purpose of this study is to compare the cardiovascular profiles of efavirenz and rilpivirine, which are two drugs used to treat HIV infection.

Detailed description:
This is a randomized, controlled, open-label, single-center study comparing the effects of efavirenz (EFV) versus rilpivirine (RPV) on endothelial function in a total of 40 HIV-uninfected healthy volunteers (20 in each arm) at the Indiana University Medical Center. Enrolled subjects will have their brachial artery flow-mediated dilation (FMD), a measure of endothelial function, and other cardiovascular, inflammatory, and oxidative stress parameters measured at baseline and again after 4 weeks of study treatment.

Arms:
arm 1: Efavirenz 600mg given nightly without food for 30 days arm 2: Rilpivirine 25mg given daily with meals for 30 days

Interventions: intervention 1: Efavirenz intervention 2: Rilpivirine
Intervention descriptions: intervention 1: 600mg orally every evening intervention 2: 25mg orally once daily

Protocol document: