The REPRIEVE trial (A5332, CTN 293 – Randomized Trial to Prevent Vascular Events in HIV) is the first large-scale multinational Phase IV study to test a strategy for heart disease prevention in people living with HIV. The study will enroll 6,500 participants in the U.S., Canada, and Thailand over the course of six years.
“The REPRIEVE trial fosters collaboration with our U.S. counterparts at the ACTG and connects our researchers to larger studies that benefit Canadians living with HIV,” says Dr. Aslam Anis, CTN National Director.
Previous studies have shown that heart disease – including heart attack and stroke – are 50 to 100 per cent more likely for people living with HIV. Studies have demonstrated that HIV patients have an increased risk of heart attack compared to the average population. This brings up an important question: should HIV patients be prescribed statins as a prevention measure, even if they don’t qualify for statin use under current guidelines?
REPRIEVE tests whether a daily dose of a statin will reduce the risk of cardiovascular disease among people living with HIV (for whom statins are not already recommended). Statin medications have known properties to reduce inflammation and decrease LDL (low-density lipoprotein) cholesterol levels (or “bad” cholesterol that builds up on the walls of arteries). Participants in the trial will be randomized to receive a statin medication (pitavastatin) or a placebo pill.
“We need well-powered studies to arm health care providers with data on how we manage risk for cardiovascular disease and other aging-related comorbidities,” says Dr. Sharon Walmsley, CTN National Co-director and an investigator leading one of the Canadian sites for REPRIEVE.
REPRIEVE will be recruiting at over 100 sites globally, with seven sites in Canada including Hamilton, Montreal, Quebec City, Toronto, and Vancouver. It is anticipated that 500 women and men from ages 40-75 will be recruited in Canada, for a global total of 6,500 participants. As of the end of February, 78 sites were open with over 1000 participants enrolled.
The U.S.-based National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI) in collaboration with the ACTG is funding the study with support from the National Institute of Allergy and Infectious Diseases (NIAID). Kowa Pharmaceuticals America, manufacturer of pitavastatin, is donating the study drug and placebo and also offering some funding. The principal investigator for the study is Dr. Steven Grinspoon from Massachusetts General Hospital, Boston.