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NIH Study Explores Heart Disease Prevention in HIV Patients
The National Institutes of Health (NIH) has launched a clinical trial to assess the effects of aspirin and cholesterol-lowering drugs (statins) in preventing cardiovascular disease in individuals with long-term human immunodeficiency virus (HIV) infections.
This group, which includes patients receiving antiretroviral therapy (ART) as well as “elite controllers” who can limit the virus without ART, has a higher risk of developing heart disease and stroke compared with the general population.
The study is funded by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).
“With the remarkable success of antiretroviral therapy, people living with HIV have a near-normal life expectancy,” said NIAID Director Anthony S. Fauci, MD “However, as this population ages, noninfectious complications, such as cardiovascular disease, begin to arise. We need to study the effects on the immune system of drugs normally prescribed for these conditions to ensure that they are beneficial for HIV-infected individuals.”
Researchers have long speculated that the enhanced risk of heart disease and stroke in individuals with long-term controlled HIV infections is associated with drug toxicity, immune defects, and chronic inflammation. The new study will specifically examine the role of chronic inflammation and will allow researchers to observe how drug-related changes influence the levels of virus.
“Elite controllers and people on ART have elevated levels of clotting factors and blood markers that indicate inflammation and an active immune response,” said Irini Sereti, MD, chief of the HIV Pathogenesis Unit in the NIAID Laboratory of Immunoregulation, which leads the clinical trial. “Over time, these factors likely contribute to an enhanced risk of cardiovascular disease, so if we can lower the levels of these factors with aspirin or statins, then maybe we can lower the risk of disease, too.”
The study, which is currently recruiting, will enroll elite controllers and people receiving ART who have not used aspirin or statins during the past 6 months. The participants will be monitored for 3 months to establish baseline levels of clotting and inflammatory agents in their blood. Afterwards, the participants will be randomly assigned to receive either aspirin or atorvastatin for 9 months. The researchers will monitor clotting and inflammatory markers from blood samples and will use magnetic resonance imaging (MRI) scans to measure the thickness of blood vessels in the neck.
Source: NIH; October 29, 2014.