Cardiometabolic Effects of Eplerenone in HIV Infection
Stopped early · Phase 2
Conditions studied: Cardiac Steatosis, Hepatic Steatosis
In brief
Background: People with human immunodeficiency virus (HIV) are at a high risk of getting visceral or deep belly fat. Visceral fat can cause health problems like heart or liver disease. Researchers want to see if a blood pressure drug can help by blocking a hormone in the body. Objective: To see if eplerenone reduces fat stored in the heart muscle and liver in people with HIV and increased visceral fat. Eligibility: Adults ages 18 75 with HIV and increased waist circumference. Increased waist circumference is defined as more than 40 inches in men and more than 35 inches in women. Design: Participants will be screened with: Physical exam Medical history Blood tests Measurements of hips, waist, legs, arms, shoulders, and neck Magnetic resonance imaging (MRI) scan. They will lie on a table that slides into a machine. Electrocardiogram (EKG) to measure heart electrical activity Transient elastography, a special ultrasound to measure liver tissue stiffness A small piece their liver collected (optional) Participants will have a baseline visit: Physical exam Medical history Blood tests DEXA scan to measure body fat, muscle mass, and bone density. Participants will lie on a table while a very small dose of x-rays goes through the body. Resting energy expenditure (REE). This measures the amount of oxygen breathed in and carbon dioxide breathed out. Participants will get a 1-week supply of eplerenone. They will take one pill per day. Participants will have a follow-up visit 1 week later. They will have: Physical exam Medical history Blood tests 23-week supply of eplerenone Participants will have 5 more follow-up visits. Participants will have a final study visit, repeating many of the screening and baseline tests.
Key facts
- Study ID
- NCT02629094
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 5
- Starts
- 2015-12-02
- Expected to finish
- 2017-09-11
- Last updated by the study team
- 2018-07-17
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m\^2, serum creatinine > 1.5 mg/dL
- Serum potassium > 5.5 mEq/L, alanine aminotransferase > 2.5 times the upper limit of normal, hemoglobin (Hgb) < 11 g/dL
- Uncontrolled hypertension: systolic blood pressure greater than or equal to 160 mm Hg or diastolic blood pressure greater than or equal to 100 mm Hg
- A blood pressure < 90mmHg systolic or < 50mm Hg diastolic
- Screening EKG with a significant heart block (e.g. PR > 300 ms) or an EKG determined significant by Cardiology consult.
- Current hepatitis C infection, unless there has been a sustained virologic response for at least 12 months
- Type 2 diabetes with microalbuminuria
- Current or prior steroid use within past 6 months (except short-course or single-dose administration). Stable use of inhaled or nasal steroids are allowed.
- Use of angiotensin converting enzyme (ACE) inhibitors, angiotensin reporter blockers (ARBs), potassium-sparing diuretics, and other medications that may increase the risk of hyperkalemia
- Use of potassium supplementation or other medications known to increase potassium
- Concomitant use of strong inhibitors and/or inducers ofof cytochrome P450 isozyme (CYP)3A4
- If receiving testerone, estrogen or progesterone therapy, must be on a stable dose for at least 3 months.
- Current use of growth hormone or growth hormone-releasing hormone
- Current serious viral, bacterial, or other infection (excluding HIV)
- Current active substance abuse/dependence
- Substantial history of cardiovascular disease, including prior myocardial infarction (MI), congestive heart failure, or stroke
- Contraindication to MRI
- Pregnant or planning to become pregnant
- Breastfeeding
- Any condition that, in the opinion of the PI, may substantially increase the risk of participation
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.