Clinical trialNCT02629094TerminatedPhase 2Interventional

Cardiometabolic Effects of Eplerenone in HIV Infection

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment5Cardiac SteatosisHepatic Steatosis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Colleen M Hadigan, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Inspra /Eplerenone

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 2 Dec 2015
Primary completion: 11 Sept 2017
Completion: 11 Sept 2017
Last update posted: 17 Jul 2018
Registered enrollment: 5
Registry id: NCT02629094

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.