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Reducing Arterial Inflammation Using Eplerenone and Statins in HIV
Sponsor: Massachusetts General Hospital
Summary
HIV has transitioned to a chronic disease in which well-treated persons remain at higher risk for heart disease when compared to the general population. Statin medications have been shown to reduce the number of events related to heart disease, but there are still individuals who will have complications from heart disease despite statin use. This study is being conducted to determine whether adding on another medication to statins called eplerenone, which has been shown to reduce inflammation in the heart vasculature among persons with HIV, can further decrease the risk of heart disease in HIV through its anti-inflammatory and blood pressure-lowering potential.
Official title: Study to Understand the Reduction in Arterial Inflammation Combining Statins and Eplerenone
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2027-03-01
Completion Date
2031-05-31
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Eplerenone
Eplerenone is an oral mineralocorticoid receptor antagonist, which is currently FDA approved for treatment of hypertension and heart failure. This intervention was chosen based on preliminary data suggesting a benefit on arterial inflammation in HIV. This intervention will be used as add on therapy to background moderate intensity statin to target residual arterial inflammation in HIV. Active study drug will be blinded by the clinical trials pharmacy. Daily dosing starts at 50 mg PO daily for the first week, then will be increased to 50 mg PO twice daily at the 2 week visit. Participants will remain on the 50 mg PO twice daily dosing for a total of 12 months. Dose reductions will occur as outlined in the protocol for hypotension, elevated potassium, and elevated renal function.
Placebo
Identical placebo will be prepared by the Clinical Trials Pharmacy.
Locations (2)
UCLA Center for Clinical AIDS Research and Education (CARE)
Los Angeles, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States