Cardiometabolic Effects of Eplerenone in HIV Infection
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|ClinicalTrials.gov Identifier: NCT02629094|
Recruitment Status : Terminated
First Posted : December 14, 2015
Results First Posted : July 17, 2018
Last Update Posted : July 17, 2018
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.
To see if eplerenone reduces fat stored in the heart muscle and liver in people with HIV and increased visceral fat.
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.
Participants will be screened with:
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:
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:
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Steatosis Hepatic Steatosis||Drug: Inspra /Eplerenone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cardiometabolic Effects of Eplerenone in HIV Infection|
|Study Start Date :||December 2, 2015|
|Actual Primary Completion Date :||September 11, 2017|
|Actual Study Completion Date :||September 11, 2017|
Intervention: Eplerenone will be administered for 6 months as follows: 25 mg once daily for 1 week and then 50 mg once daily for the remainder of the study.
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.
- Improvement of Cardiac Steatosis: Mean Change in Intraventricular Septum Percentage of Lipid by MR Spectroscopy. [ Time Frame: 24 weeks ]Mean change in intraventricular septum percentage of lipid by MR spectroscopy. This was calculated by subtracting the baseline intraventicular septum percentage value of lipid from the week 24 intraventicular septum percentage value of lipid by MR spectroscopy.
- Improvement of Hepatic Steatosis: Mean Change in Hepatic Percentage of Lipid by MR Spectroscopy [ Time Frame: 24 weeks ]Mean change in hepatic percentage of lipid by MR spectroscopy. This was calculated by subtracting the baseline hepatic percentage value of lipid from the week 24 hepatic percentage value of lipid by MR spectroscopy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02629094
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Colleen M Hadigan, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|