Massachusetts General Hospital
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.
Heart disease remains one of the principal causes of morbidity and mortality among the well-treated HIV population. Heart disease is on the rise in HIV, quickly advancing as a predominant source of death in HIV and is a key focus of longitudinal HIV clinical care for which we have few recognized prevention or treatment strategies. While the HIV population can achieve good virologic control with the use of contemporary antiretroviral therapies (ART), they have a higher burden of heart disease and other metabolic complications compared to the general population. Recently, we learned that statins…
Inclusion Criteria: 1. ART use \>12 months; 2. Viral load \<200 copies/mL; 3. Stable use (\>90 days) of moderate-intensity statin (pitavastatin 4mg daily, atorvastatin 10-20mg daily, rosuvastatin 5-10mg daily; simvastatin 20-40mg; pravastatin 40-80mg) or maximally tolerated statin if prior history of statin intolerance; 4. ASCVD risk ≥5%; 5. Baseline TBR≥2.3 on cardiac 18F-FDG-PET Exclusion Criteria: 1. MRA use within the last 90 days; 2. Use of potassium (K) supplements; 3. Known HFrEF or primary aldosteronism; 4. Known Addison's disease 5. Use of ritonavir, nelfinavir, clarithromycin, and…
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.
Identical placebo will be prepared by the Clinical Trials Pharmacy.
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