What’s the Big Deal?
AIDS-related complications and deaths are declining, while heart disease among HIV-infected individuals is emerging as a major public health problem. This is happening despite effective treatment for HIV. People living with HIV are 50 to 100% more likely to develop heart disease — this includes heart attack and stroke — compared with people who do not have HIV. Increased chronic inflammation related to HIV may be contributing to the increased risk of heart disease.
What’s Being Done about Heart Disease in HIV?
REPRIEVE, which stands for a Randomized Trial to Prevent Vascular Events in HIV, is the first large-scale randomized clinical research trial to test a strategy for heart disease prevention among people living with HIV. Specifically, REPRIEVE will test whether a daily dose of a statin (pitavastatin) reduces the risk of heart disease among HIV-infected individuals.
What are Statin Medications?
In people without HIV, statin medications reduce cholesterol and prevent heart disease. In smaller studies among people with HIV, statins have also to decreased inflammation; we need to confirm these findings among people living with HIV.
Participants in REPRIEVE will be randomized to receive pitavastatin or a placebo pill.
Pitavastatin is a statin that is approved by the FDA, and based on current information, pitavastatin is considered safe for use with all MD-prescribed antiretroviral therapy regimens.
Key Criteria to Participate in REPRIEVE
- HIV-infected and between the ages of 40 and 75
- On antiretroviral therapy (ART) for at least 6 months prior to study entry
- No history of heart disease (including heart attack or stroke)
- Not be currently using a statin drug
- Low to moderate risk for developing heart disease
How Do We Assess Your Risk for Developing Heart Disease?
At the screening visit your 10-year risk for developing atherosclerotic (build up of plaque) heart disease using the American College of Cardiology/American Heart Association Risk Calculator. Based on screening evaluations if your risk is ≤10% you may qualify for REPRIEVE.
We chose to study people living with HIV who are at low to moderate risk for developing heart disease to ensure that our population will be comparable in terms of race, smoking and other risk factors with the HIV population.
More Important Details About REPRIEVE
The REPRIEVE trial will include 7,500 participants and will be conducted at approximately 100 clinical research sites, in the United States and abroad (click here to find a site near you). The trial will be conducted through the AIDS Clinical Trials Network and many other sites approved by the NIH Division of AIDS..
Who Funds REPRIEVE?
The REPRIEVE trial is funded by the National Heart Lung and Blood Institute at the National Institutes of Health, with significant support and collaboration from the National Institute of Allergy and Infectious Diseases (NIAID) through its Division of AIDS. In addition, Kowa Pharmaceuticals America, Inc. will be providing study drug and additional support.