CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
Eplerenone and lifestyle +1 moredrug
Likely dose
Eplerenone and lifestyle 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01405456
NCT01405456N/ACompleted

Randomized Placebo-controlled Trial to Investigate the Effects of Eplerenone in Patients With HIV-associated Abdominal Fat Accumulation

Massachusetts General Hospital·interventional·Posted Jul 29, 2011·Updated Jun 15, 2018

In Brief

A clinical study evaluating Eplerenone and lifestyle and placebo and lifestyle for HIV. Completed, enrolled 46 participants across 1 site.

Detailed Summary

The purpose of this study is to test the effects of a drug, eplerenone, along with lifestyle modification to affect sugar metabolism, body fat distribution, and cardiovascular health in HIV-infected individuals. In non-HIV-infected individuals, recent data has shown that aldosterone, a hormone that regulates salt and water balance, is increased in association with increased belly fat and decreased insulin sensitivity. In HIV-infected individuals, aldosterone appears to be higher in individuals with increased belly fat, and increased aldosterone appears to be strongly associated with impaired sugar metabolism. In this study, the investigators will test the effects of eplerenone, which is a medication that blocks the actions of aldosterone, along with lifestyle modification. The investigators hypothesize that eplerenone may improve sugar metabolism, improve markers of cardiovascular health, and reduce fat accumulation in liver and muscle.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 29, 2011
Enrollment StartJan 1, 2012
Primary CompletionMay 3, 2017
Study CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 14.9 years ago

Interventions

Eplerenone and lifestyledrug

eplerenone 50mg by mouth daily as well as lifestyle counseling

placebo and lifestyleother

placebo pill daily and lifestyle counseling