The Washington University AIDS Clinical Trials Unit is the first in the nation to open a clinical trial evaluating whether statins reduce heart attacks and strokes in patients with human immunodeficiency virus (HIV).
An estimated 6,500 patients will be enrolled in the trial, and researchers at Washington University School of Medicine in St. Louis aim to recruit 100 study participants locally. The success of statin therapy will be assessed by the rate of heart attacks and strokes in patients receiving the drug compared with those taking a placebo.
While effective drug treatments have led to declines in HIV-related deaths and complications, cardiovascular disease among people with HIV is a major public health problem. People living with HIV are 50 to 100 percent more likely to develop heart disease than people without the virus.
The REPRIEVE (Randomized Trial to Prevent Vascular Events in HIV) trial will treat patients with either a placebo or statins — drugs used to reduce cholesterol levels. Statins also reduce inflammation levels in blood vessels, a benefit researchers hope will help patients with HIV.
“Even in patients whose virus levels are well-controlled by anti-HIV medications, the infection still boosts the risk of heart attack and stroke to 1 ½ to two times that of people without HIV,” said David B. Clifford, MD, the Melba and Forest Seay Professor of Clinical Neuropharmacology in Neurology at Washington University School of Medicine in St. Louis. “We think that’s due to inflammation caused by the virus and by some anti-HIV drugs. We want to see if statins can help with that.”
Patients in the study will be randomly selected to receive either a placebo or pitavastatin, a statin proven safe for use in conjunction with anti-HIV medications. Risks of statin treatment are rare and include the onset of diabetes and myositis, a condition that involves inflammation of the muscles. Physicians will test for these side effects at medical evaluations every four months for up to six years.
To volunteer for REPRIEVE, participants must:
Be age 40 to 65;
Have been on an anti-HIV medication for at least six months before entering the clinical trial;
Have no prior history of heart attack or stroke.
Participants also must not currently be receiving a statin or qualified to take a statin based on their cholesterol levels.
The REPRIEVE trial is funded by the National Heart, Lung and Blood Institute and the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIH).
The AIDS Clinical Trials Unit receives funding from the allergy and infectious diseases institute to find treatments for AIDS and HIV-related complications, such as dementia, neuropathy, and cardiovascular disease. The AIDS Clinical Trials Unit is part of a national network of clinical trials units, known collectively as the AIDS Clinical Trials Group.
Filed Under: Drug Discovery