As HIV-positive people continue living longer due to highly active antiretroviral therapy, cardiovascular disease has become a growing concern. According to the National Institute of Allergy and Infectious Diseases, several factors put those with HIV at nearly double the risk of developing heart disease than the non-poz population.
HIV causes inflammation, and inflammation leads to activated immune cells, and both lead to the buildup of plaque in arteries. Secondly, a side effect of antinretroviral therapy is an increase in cholesterol levels, which also contributes to cardiovascular disease. Research has also shown that heart disease risk factors (including things like smoking) are also higher among people living with HIV.
So earlier this year, the National Institutes of Health’s National Heart, Lung, and Blood Institute and National Institute of Allergy and Infectious Diseases announced an international clinical trial to test whether taking a statin (a kind of drug that reduces fats in the blood and lowers cholesterol) can reduce the risk for heart attacks, strokes, and heart disease in people with HIV.
“Research suggests that cholesterol-lowering statins may inhibit immune cell activation and inflammation and shrink arterial plaque,” said NIAID director Anthony S. Fauci in a written statement. “Therefore, these medications provide an intriguing possibility for improving cardiovascular outcomes in people with HIV.”
Researchers are still signing up volunteers (a total of 6,500 participants will be chosen) for the the double-blind, randomized, placebo-controlled clinical trial known as the Randomized Trial to Prevent Vascular Events in HIV, or REPRIEVE. This is the largest to date focused on HIV-related heart disease.
Participants must be between the ages of 40 and 75, and not currently meet America's national guidelines for statin therapy. They must be on and continue antiretroviral therapy and agree to take a daily dose of a statin drug or a placebo (neither they nor the study administrators will know which participants receive which pill).
Study participants will be followed for up to six years, as doctors assess their risk of heart disease, heart attack, or stroke. The researchers will continue to evaluate the safety of statin therapy and look for any new side effects. All participants will get "guidance on steps to improve heart health" including excercising and eating well. Investigators will also conduct a sub-study involving 800 participants, examining the effects of pitavastatin on coronary artery disease in people with HIV.
According to NIAID, pitavastatin was selected because a minimal number of interactions have been documented between pitavastatin and HIV medications, relative to most other statins. The maker of pitavastatin, Kowa Pharmaceuticals America Inc,, is donating the drug, the placebo, and funds for the study.
Roughly 100 sites in Canada, Thailand, and the United States will participate and the study will be followed by researchers from Harvard Medical School, Harvard School of Public Health, and Duke University.