Status:
COMPLETED
Eplerenone in HIV Associated Abdominal Fat Accumulation
Lead Sponsor:
Massachusetts General Hospital
Conditions:
HIV
Eligibility:
All Genders
30-65 years
Phase:
NA
Brief 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 i...
Detailed Description
The study is 12 months long, with two phases. In the initial, 6-month phase, volunteers are randomly assigned to receive either eplerenone or placebo (an inactive pill). In addition, all volunteers wi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01405456
Start Date
January 1 2012
End Date
November 1 2017
Last Update
June 15 2018
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114