Conditions: HIV
Keywords: Endothelial function Vitamin D Efavirenz Raltegravir
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief summary:
Efavirenz, a commonly used HIV medication, may cause worsening vascular function and bone problems. The purpose of this study is to determine if switching efavirenz to raltegravir, a newer HIV medication, will improve vascular function and tests of bone health.

Detailed description:
Cardiovascular disease (CVD) is an increasingly important comorbidity in HIV-infected patients. Our preliminary data suggests that efavirenz may worsen endothelial function, which in turn may increase the risk for future CVD events. Efavirenz has also been linked to lower vitamin D levels, which may in turn result in increased bone fragility. Raltegravir is not known to affect either endothelial function or vitamin D levels. Therefore, switching efavirenz to raltegravir in patients with suppressed HIV viremia may lead to improved outcomes.

Arms:
arm 1: Tenofovir/emtricitabine/efavirenz arm 2: Tenofovir/emtricitabine/efavirenz is switched to tenofovir/emtricitabine plus raltegravir

Interventions: intervention 1: Tenofovir/emtricitabine intervention 2: Tenofovir/emtricitabine/efavirenz intervention 3: Raltegravir
Intervention descriptions: intervention 1: Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine intervention 2: Continued therapy with tenofovir/emtricitabine/efavirenz intervention 3: Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine

Protocol document: