The clinical trial is funded by the National Heart, Lung and Blood Institute and the National Institute of Allergy and Infectious Diseases.
“For many years we have noticed that people living with HIV have a higher risk of having a heart attack and stroke,” says Carl Fichtenbaum, MD, professor of infectious diseases in the UC College of Medicine. “There is a lot of data that has been generated over the last decade showing that the risk is between two to five times higher in people with HIV infection.
“We need to try and develop a strategy to prevent this,” says Fichtenbaum, vice chair of the national study and lead investigator at UC. “We already know in the general population that if you use statins, which lowers cholesterol, we can reduce the risk of heart attacks and stroke.”
Fichtenbaum says it’s not clear whether statins will have the same effect in individuals living with HIV infection.
“We don’t know if this works in the same way with people living with HIV infection,” he says. “There appear to be differences in the way people develop heart attacks and in strokes with differences in the kinds of blockages that are seen in their blood vessels.”
UC will be part of a multi-center study that involves 6,500 persons with HIV infection across the United States. In Cincinnati, Fichtenbaum and other researchers hope to enroll 100 to 150 people in a clinical trial over the next three years to test the effect of statins in persons living with HIV.
Study participants—HIV-infected men and women ages 40 to 75 who are on antiretroviral therapy and have no known cardiovascular disease and low traditional risk factors—will be randomized to receive either pitavastatin or a placebo for up to 72 months.
Kowa Pharmaceuticals America, Inc. is donating pitavastatin and providing support for the study. Fichtenbaum has previously served as a speaker for Kowa.
“We also believe that statins have many properties that lower inflammation and in fact using these medications may be beneficial in reducing other problems that may occur in people who are living with HIV,” says Fichtenbaum.
Researchers have found higher rates of cancer, osteoporosis, kidney disease and serious infections in individuals living with HIV and AIDS. Statins may be able to help control some of these ailments, says Fichtenbaum.
“What investigators hope to learn is whether giving a statin drug to persons that normally would not qualify to receive one under current guidelines will benefit from using this agent,” says Fichtenbaum.
Individuals interested in knowing more or participating in the statins clinical trial in Cincinnati may contact Sharon Kohrs at 584-6383. More information about the national study is available at http://reprievetrial.org/
Media Contact: Cedric Ricks, 513-558-4657