A5332: Randomized Trial to Prevent Vascular Events in HIV – REPRIEVE

This study is conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health.

This is a prospective, double-blind, randomized, placebo-controlled, multicenter efficacy study in 6500 subjects, with individual subjects to be followed for up to 72 months. The purpose is to study the efficacy of statins to reduce the risk of cardiovascular disease in HIV-infected patients.

HIV-infected persons face an increased risk of CVD morbidity and mortality, yet no preventive strategies for CVD risk reduction have been proven for this population. Among HIV-infected individuals, immune activation may contribute in unique ways to atherosclerosis and ensuing cardiovascular events. Statins affect both traditional CVD risk factors (LDL cholesterol) and have pleiotropic effects to reduce inflammation and immune activation. Thus, statins may target the unique mechanisms of cardiovascular disease in HIV.

Primary Objective:

To determine the effects of pitavastatin as a primary prevention strategy for major adverse cardiovascular events (MACE) in HIV.

Secondary Objectives:

1. 
   The effects of pitavastatin on the components of MACE and all-cause mortality.
2. 
   The effects of pitavastatin on LDL and non-HDL in relationship to MACE.
3. 
   Whether baseline traditional risk factors and time updated HIV-specific immunological risk factors are predictive of MACE and pitavastatin effects on MACE.
4. 
   The effects of pitavastatin on the incidence of serious non-CVD events. 
5. 
   The safety of pitavastatin in the HIV population.