Eplerenone in HIV Associated Abdominal Fat Accumulation

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 will receive counseling about healthy diet and lifestyle, and will be asked to
follow guidelines for a healthy level of physical activity. In the second 6-months of the
study, all volunteers will continue to receive lifestyle modification and all will receive
eplerenone.

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 ≤ 65 years of age

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