Eplerenone in HIV Associated Abdominal Fat Accumulation
Completed · Not applicable · Has a placebo group
Conditions studied: HIV
In brief
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.
Key facts
- Study ID
- NCT01405456
- Run by
- Massachusetts General Hospital
- People needed
- 46
- Starts
- 2012-01-01
- Expected to finish
- 2017-11-01
- Last updated by the study team
- 2018-06-15
Who can join
Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Increased waist circumference based on NCEP guidelines (>102cm in men and >88cm in women) and impaired glucose tolerance (either IFG > 100 mg/dL but < 126 mg/dL or 2hr glucose > 140 mg/dl but < 200 mg/dL, or fasting insulin >12 uIU/mL)
- HIV positive for 5y and on a stable ART regimen for at least 12 months
- Age ≥ 30 and ≤ 65 years of age
You may not qualify if…
- ACE Inhibitor, ARB, verapamil, or spironolactone
- Potassium supplementation
- Estimated GFR<60, creatinine > 1.5 mg/dL
- Serum K > 5.5 mEq/L, ALT > 2.5 times the upper limit of normal, Hgb < 11g/dL
- Uncontrolled hypertension (SBP ≥ 160 or DBP ≥ 100)
- Current or prior steroid use within past 6 months
- Known history of diabetes mellitus or current use of anti-diabetic medications
- Concomitant use of full dose ritonavir, nelfinavir, clarithromycin and other strong inhibitors of CYP34A
- Use of St. John's Wart (CYP3A4 inducer)
- Pregnant or actively seeking pregnancy, breastfeeding
- For women: Pregnant or actively seeking pregnancy, breastfeeding, failure to use an acceptable non-hormonal form of birth control, including abstinence, barrier contraceptives, or non-hormonal IUD.
- Estrogen or progestational derivative use within 3 months
- Testosterone use for non-physiologic purposes, or physiologic testosterone replacement for < 3 months.
- Current growth hormone or growth hormone releasing hormone use
- Current viral, bacterial or other infections (excluding HIV)
- Current active substance abuse
- Patients with a significant history of cardiovascular disease, including prior MI or stroke
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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