A Phase 2/3 interventional study of Eplerenone and Placebo in HIV (Human Immunodeficiency Virus), Cardiovascular Diseases (CVD) and Arterial Inflammation, sponsored by Massachusetts General Hospital. Not yet recruiting at 2 sites in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Massachusetts General Hospital · Phase 2/3, Interventional, and Treatment
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 can reduce the number of cardiovascular events among persons with HIV (PWH) by 36%. However, ART and statins do not mitigate this risk of heart disease completely among PWH. Even among those treated adequately with ART and statins, 39% still remain at risk for a cardiovascular event. Despite goal-directed treatment with ART and statins, there remains untreated inflammation, which may account for this residual risk. We have previously shown unique physiology, such that elevations in a hormone called aldosterone are associated with increased inflammation in the vasculature among PWH. We then tested a medication known to block aldosterone, called eplerenone, which in a class of medications called mineralocorticoid receptor blockers, on inflammation in the vasculature among PWH who were not treated with statin medication and saw a robust decrease in arterial inflammation. Currently, there are no medication to help reduce inflammatory-mediated heart disease in HIV. In this way, it may be that the addition of eplerenone to statin therapy could further mitigate heart disease risk and augment statin therapy as the standard of care for primary prevention. Moreover, we know that inflammation in the vasculature may be associated with the development of non-calcified plaque, a type of plaque that is highly inflamed and prone to rupture and cause a heart attack. Overall, the population with HIV can be used as a paradigm and model to understand inflammatory sequelae in other highly metabolic populations, and findings from these studies could have applications to those other groups, such as those with obesity.
The main objectives of this study are to test whether addition of the medication eplerenone to background statins may reduce residual arterial inflammation further among PWH. We will further understand a potential mechanism by which arterial inflammation is linked to heart disease by evaluating changes over time in non-calcified plaque. Eplerenone is an oral medication taken twice daily and is FDA approved for treatment of hypertension and heart failure with reduced ejection fraction following myocardial infarction, and we are evaluating whether this medication could be useful to improve inflammatory-mediated heart disease and overall inflammation in HIV. This is a multi-site (MGH/UCLA), 12 month randomized placebo-controlled study among ART- and statin-treated PWH with baseline arterial inflammation to study the effects of MRA vs. placebo as add-on to standard of care moderate-intensity statin on arterial inflammation.
2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.
This study's planned enrollment of 124 is above the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Patients randomized into the Eplerenone arm will receive 50 mg administered orally twice a day for 12 months.
Drug: Eplerenone
Patients randomized into the Placebo arm will receive 50 mg administered orally twice a day for 12 months.
Drug: Placebo
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.
Arterial Inflammation
Change in target to background ratio (a measure of arterial inflammation) of the index vessel or Change in target to background ratio (a measure of arterial inflammation) of the most diseased segment of the index vessel measured via cardiac positron emission tomography/computed tomography.
Time frame: Baseline, 12 Months
Coronary Inflammation
Change in pericoronary adipose tissue density measured via coronary computed tomography angiography
Time frame: Baseline, 12 Months
Systemic Inflammation
Change in MCP-1, hsCRP, IL-6, LpPLA2
Time frame: Baseline, 12 Months
24 hour Ambulatory Blood Pressure Monitoring
Change in blood pressure variability or nocturnal dipping
Time frame: Baseline, 12 Months
Non-Calcified Plaque
Change in non-calcified plaque volume measured via coronary computed tomography angiography correlated with change in arterial inflammation as assessed by target to background ratio of the index vessel measured via cardiac positron emission tomography/computed tomography
Time frame: Baseline, 12 Months
High-Risk Plaque Features
Change in low Hounsfield Unit attenuation or positive remodeling measured via coronary computed tomography angiography correlated with change in arterial inflammation assessed by target to background ratio of the index vessel measured via cardiac positron emission tomography/computed tomography
Time frame: Baseline, 12 Months
Coronary Inflammation
Change in pericoronary adipose tissue density measured via coronary computed tomography angiography correlated with change in non-calcified plaque volume measured via coronary computed tomography angiography
Time frame: Baseline, 12 Months
Plan to share: No
Start is estimated for Mar 2027; primary completion for May 2031, 50 months later.
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Studies of the drug tested here: Eplerenone
Acquired Immunodeficiency Syndrome →
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