A5332: Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE)

Treatment Category

Treatment Experienced

Study Description

REPRIEVE (A5332) is a large double-blind, randomized, placebo-controlled study of pitavastatin or placebo for about 72 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).

More Information about A5332

Why is this study being done?

HIV causes inflammation (irritation) inside the body that may contribute to diseases such as heart disease. HIV medications can lower inflammation, however the levels of inflammation can remain higher compared to people who are not infected with HIV. Statins, such as pitavastatin, are medications that are used to lower the levels of cholesterol and triglycerides (fat in the blood) and have been shown to lower levels of inflammation and heart disease.

The main purpose of this study is to see if pitavastatin can prevent heart disease and heart disease related deaths in people with HIV infection who are taking HIV medications.

Who can join?

  • HIV infected men and women between the ages of 40 and 75
  • On HIV medications for at least 6 months
  • CD4 cell count greater than 100
  • No history of cardiovascular disease, such as heart attack, stroke, etc.
  • No history of cancer in the last 3 years
  • Not currently using a statin drug

What do I need to do in the study?

Participants will continue to take their HIV medications and will be randomized (like flipping a coin) to take either:

  • Pitavastatin one pill daily or
  • Placebo for pitavastatin one pill daily

Participants will need to be seen in the clinic every 4 months for up to 6 years.

What treatments or drugs are involved with this study?

The study treatments that will be provided through the study are pitavastatin or placebo for pitavastatin.  HIV medications will not be provided by the study.

Study Status: 

Participating ACTG Sites