Project no.: A5332 (NCT02344290)
This is a randomized trial to prevent vascular events in HIV, tests whether a daily dose of a statin will reduce the risk of cardiovascular disease among HIV-infected individuals (for whom statins are not already recommended according to 2013 US Cholesterol Treatment Guidelines).
Brief Summary: REPRIEVE (A5332) is a large double-blind, randomized, placebo-controlled study of pitavastatin or placebo for about 84 months. The trial is testing the effect of statin therapy on preventing heart disease and death in HIV-infected persons on HIV medications who do not meet guidelines for starting statins. Known as the Randomized Trial to Prevent Vascular Events in HIV, or REPRIEVE, the multicenter international clinical trial is the largest trial to date focused on HIV-related cardiovascular disease. REPRIEVE will test whether statin administration can reduce the risk for major adverse cardiovascular events, such as heart attacks, strokes, and heart disease, in people with HIV infection. Researchers hypothesize that statins should reduce plaque development and improve cardiovascular outcomes in people with HIV. The ultimate objective of the trial is to inform the best clinical approach to preventing cardiovascular disease in people infected with HIV. The trial is supported by the National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI) and National Institute of Allergy and Infectious Diseases (NIAID).