The US National Institutes of Health (NIH)/National Heart, Lung and Blood Institute (NHLBI) are starting a multi-million dollar outcomes trial, REPRIEVE, to investigate whether a daily dose of pitavastatin will reduce the risk of cardiovascular disease (CVD) in people living with HIV.
The drug for evaluation in the trial and its related funds will be provided by Kowa Pharmaceuticals America.
NHLBI with additional resources and collaboration from the National Institute of Allergy and Infectious Diseases (NIAID) and the AIDS Clinical Trials Group (ACTG) Network have sponsored the trial.
The six-year randomised, double-blind clinical trial will enrol around 6,500 participants from about 100 trial sites in North America.
Steven Grinspoon will lead the REPRIEVE trial. He is director of the MGH Program in Nutritional Metabolism and professor of Medicine at Harvard Medical School.
The trial’s co-principal investigators include Pamela Douglas professor of Medicine at Duke University School of Medicine, Udo Hoffmann professor of Radiology at Harvard Medical School and Heather Ribaudo senior biostatistician at Harvard School of Public Health.
Dr Grinspoon said: "The risks of heart attack and stroke in HIV-infected individuals are significantly higher than they are in uninfected people, and while some of these patients have traditional cardiovascular risk factors, recent studies suggest that HIV infection itself confers a unique set of risks, including immune system activation and arterial inflammation.
"Those findings contributed to the hypothesis that statin therapy – which reduces inflammation and immune activation, as well as lipid levels – may be particularly well tailored to reducing that cardiovascular risk.
"REPRIEVE will be among the largest randomised clinical trials conducted in the HIV population and the first study designed to investigate a large-scale cardiovascular disease prevention strategy in this population.
"By addressing the critical question of statin efficacy in this group of patients, the study should provide important information as to efficacy and safety of this strategy for primary cardiovascular disease prevention in this population."
The trial will include HIV-infected men and women, aged between 40 and 75 years, who are being treated for their infection and who have no known cardiovascular disease and low traditional risk factors for cardiovascular disease.
During the trial, these patients will be randomised to receive either a 4mg daily dose of pitavastatin or a placebo pill for up to 72 months.