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NIH launches clinical trial on statin therapy for HIV patients
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The NIH announced it is launching a clinical study of HIV patients to test the effectiveness of statins in reducing the risk for major cardiovascular events such as myocardial infarction, stroke and heart disease.
Investigators from Massachusetts General Hospital/Harvard Medical School, Harvard School of Public Health and Duke University have begun enrolling participants in the international Randomized Trial to Prevent Vascular Events in HIV, or REPRIEVE. The researchers hypothesize that statins should reduce plaque development and improve cardiovascular outcomes for HIV patients. The trial is supported by the National Heart, Lung, and Blood Institute and the National Institute of Allergy and Infectious Diseases.
“Research suggests that cholesterol-lowering statins may inhibit immune cell activation and inflammation and shrink arterial plaque,” NIAID Director Anthony S. Fauci, MD, said in a press release. “Therefore, these medications provide an intriguing possibility for improving cardiovascular outcomes in people with HIV.”
According to the NIH, people with HIV are up to twice as likely as those without the infection to experience MI and other forms of cardiovascular disease, a major issue in light of medical advances that are helping HIV patients to live longer.
REPRIEVE researchers will conduct the trial at about 100 sites in the United States, Puerto Rico, Canada and Thailand in collaboration with the NIH-funded AIDS Clinical Trials Group, according to the release.
Investigators plan to randomly assign 6,500 HIV-infected participants aged 40 to 75 years who would not meet current national guidelines for statin therapy to either a daily dose of Livalo (pitavastatin, Kowa Pharmaceuticals) or placebo, while continuing with ART. Pitavastatin was selected for the trial because, unlike most statins, only minimal interactions occur with HIV medications.
Investigators will follow the participants for up to 6 years, assessing them for the development of cardiovascular events such as MI and stroke. The researchers also will evaluate the safety of statin therapy and its impact on cholesterol levels, immunological parameters, and diseases such as new-onset diabetes.
Additionally, investigators will conduct a substudy of 800 participants to examine the effects of pitavastatin on coronary artery disease and inflammatory biomarkers in HIV-infected individuals.