Cardiometabolic Effects of Eplerenone in HIV Infection
Status:
Terminated
Trial end date:
2017-09-11
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)