Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT02629094
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Increased waist circumference on the basis of National Cholesterol Education Program guidelines (\> 102 cm in men and \> 88 cm in women)
2. Hepatic steatosis established by hepatic MRI greater than or equal to 5% and/or liver biopsy within the last 12 months
3. HIV-infected, HIV viral load \< 50 copies/mL and no change in ART regimen for at least 3 months
4. Age greater than or equal to 18 and less than or equal to 75 years
5. Agree to have samples stored for future research
EXCLUSION CRITERIA:
1. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m\^2, serum creatinine \> 1.5 mg/dL
2. Serum potassium \> 5.5 mEq/L, alanine aminotransferase \> 2.5 times the upper limit of normal, hemoglobin (Hgb) \< 11 g/dL
3. Uncontrolled hypertension: systolic blood pressure greater than or equal to 160 mm Hg or diastolic blood pressure greater than or equal to 100 mm Hg
4. A blood pressure \< 90mmHg systolic or \< 50mm Hg diastolic
5. Screening EKG with a significant heart block (e.g. PR \> 300 ms) or an EKG determined significant by Cardiology consult.
6. Current hepatitis C infection, unless there has been a sustained virologic response for at least 12 months
7. Type 2 diabetes with microalbuminuria
8. Current or prior steroid use within past 6 months (except short-course or single-dose administration). Stable use of inhaled or nasal steroids are allowed.
9. Use of angiotensin converting enzyme (ACE) inhibitors, angiotensin reporter blockers (ARBs), potassium-sparing diuretics, and other medications that may increase the risk of hyperkalemia
10. Use of potassium supplementation or other medications known to increase potassium
11. Concomitant use of strong inhibitors and/or inducers ofof cytochrome P450 isozyme (CYP)3A4
12. If receiving testerone, estrogen or progesterone therapy, must be on a stable dose for at least 3 months.
13. Current use of growth hormone or growth hormone-releasing hormone
14. Current serious viral, bacterial, or other infection (excluding HIV)
15. Current active substance abuse/dependence
16. Substantial history of cardiovascular disease, including prior myocardial infarction (MI), congestive heart failure, or stroke
17. Contraindication to MRI
18. Pregnant or planning to become pregnant
19. Breastfeeding
20. Any condition that, in the opinion of the PI, may substantially increase the risk of participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02629094
Study Brief:
Protocol Section:
NCT02629094