Eplerenone in HIV Associated Abdominal Fat Accumulation

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01405456
• Date of registration: 27/07/2011
• Primary sponsor: Massachusetts General Hospital
• Public title: Eplerenone in HIV Associated Abdominal Fat Accumulation
• Scientific title: Randomized Placebo-controlled Trial to Investigate the Effects of Eplerenone in Patients With HIV-associated Abdominal Fat Accumulation
• Date of first enrolment: January 2012
• Target sample size: 66
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01405456
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Katie Fitch, NP

• Name: Steven Grinspoon, MD
• Affiliation: Massachusetts General Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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)

2. HIV positive for 5y and on a stable ART regimen for at least 12 months

3. Age = 30 and = 55 years of age

4. Stable CD4 count and HIV viral load in the past year

Exclusion Criteria:

1. ACE Inhibitor, ARB, verapamil, or spironolactone

2. Potassium supplementation

3. Estimated GFR<60, creatinine > 1.5 mg/dL

4. Serum K > 5.5 mEq/L, ALT > 2.5 times the upper limit of normal, Hgb < 11g/dL

5. Uncontrolled hypertension (SBP = 160 or DBP = 100)

6. Current or prior steroid use within past 6 months

7. Known history of diabetes mellitus or current use of anti-diabetic medications

8. Concomitant use of full dose ritonavir, nelfinavir, clarithromycin and other strong
inhibitors of CYP34A

9. Use of St. John's Wart (CYP3A4 inducer)

10. Pregnant or actively seeking pregnancy, breastfeeding

11. 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.

12. Estrogen or progestational derivative use within 3 months

13. Testosterone use for non-physiologic purposes, or physiologic testosterone
replacement for < 3 months.

14. Current growth hormone or growth hormone releasing hormone use

15. Current viral, bacterial or other infections (excluding HIV)

16. Current active substance abuse

17. Patients with a significant history of cardiovascular disease, including prior MI or
stroke



Age minimum: 30 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Drug: Eplerenone and lifestyle

Other: placebo and lifestyle

Primary Outcome(s)

Insulin stimulated glucose uptake [Time Frame: 6 months]

Secondary Outcome(s)

adiponectin [Time Frame: 6 months]

c-reactive protein [Time Frame: 6 months]

flow mediated vasodilation [Time Frame: 6 months]

hemoglobin A1c [Time Frame: 6 months]

intramyocellular lipid [Time Frame: 6 months]

liver fat [Time Frame: 6 months]

plasminogen activator inhibitor 1 [Time Frame: 6 months]

potassium [Time Frame: 6 months]

visceral adipose tissue [Time Frame: 6 months]

Secondary ID(s)

2010P002095

Source(s) of Monetary Support

Please refer to primary and secondary sponsors