Eplerenone in HIV Associated Abdominal Fat Accumulation

HIV Clinical Trial

Official title:

Randomized Placebo-controlled Trial to Investigate the Effects of Eplerenone in Patients With HIV-associated Abdominal Fat Accumulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405456
• Other study ID #: 2010P002095
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: November 1, 2017

Study information

• Verified date: May 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 1, 2017
• Est. primary completion date: May 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• Eplerenone and lifestyle
eplerenone 50mg by mouth daily as well as lifestyle counseling

Other:
• placebo and lifestyle
placebo pill daily and lifestyle counseling

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Stimulated Glucose Uptake		6 months
Secondary	Visceral Adipose Tissue		6 months
Secondary	Liver Fat		6 months
Secondary	Intramyocellular Lipid		6 months
Secondary	Flow Mediated Vasodilation		6 months
Secondary	Potassium		6 months
Secondary	Hemoglobin A1c		6 months
Secondary	C-Reactive Protein		6 months
Secondary	Plasminogen Activator Inhibitor 1		6 months
Secondary	Adiponectin		6 months
Secondary	Markers of Systemic Inflammation	IL-6	6 months
Secondary	Markers of Immune Activation	MCP-1	6 months