NCT02629094

Cardiometabolic Effects of Eplerenone in HIV Infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

HIV-infected individuals are at higher risk than uninfected people for developing cardiovascular disease. Visceral adipose tissue is also increased in HIV-infected people compared to uninfected individuals. Animal studies suggest that blockade of the mineralocorticoid receptor (MR) may have beneficial effects on cardiovascular and metabolic parameters via inhibition of adipocyte differentiation and triglyceride accumulation. We will examine the effects of the MR antagonist eplerenone (50 mg daily) on HIV-infected adults with abdominal fat accumulation in a 24-week, open-label, proof-of-concept study. Magnetic resonance imaging will be conducted at screening and the final study visit to evaluate cardiac and hepatic steatosis. We anticipate that blocking the effects of increased aldosterone secretion with eplerenone will significantly reduce intramyocardial lipid content and hepatic steatosis in this population. These effects may be accompanied by decreases in visceral adipose tissue, and improvements in dyslipidemia and inflammation, thereby improving cardiovascular health.

Conditions

• Cardiac Steatosis
• Hepatic Steatosis

Interventions

Type	Name	Description
DRUG	Inspra /Eplerenone	Eplerenone is provided as 25- or 50-mg tablets that are to be taken orally. Subjects will be dosed at 25 mg daily for 1 week, and then 50 mg daily for 23 weeks. The total duration of dosing for each subject is 24 weeks.

Timeline

• Start date: 2015-12-02
• Primary completion: 2017-09-11
• Completion: 2017-09-11
• First posted: 2015-12-14
• Last updated: 2018-07-17
• Results posted: 2018-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study