Therapeutic Approaches to HAART-Induced Lipodystrophy

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the efficacy and safety of 4 therapeutic interventions on HAART-Induced lipodystrophy. The interventions are: 1) Dietary - the effect of a high carbohydrate vs.a high cis-monounsaturated fatty acid diet. 2) The effect of aerobic exercise with dietary advice. 3) The effect of Omega-3 Fish Oil Capsules. 4) The effect of leptin therapy. These interventions are aimed at improving the metabolic complications of HAART therapy such as elevated lipids, and insulin resistance or diabetes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Amylin Pharmaceuticals, LLC.

Criteria

Inclusion Criteria - General inclusion:

• Age > 14 years

• HIV infection being treated with HIV-1 protease inhibitors for >6 months currently, or previous protease inhibitor therapy of at least 2 years duration with development of lipodystrophy and current stable therapy preferably for past 4 months.

• Fasting serum triglycerides > 200 mg/dL

Exclusion Criteria - General exclusion:

• Acute, ongoing AIDS-defining opportunistic infections.

• Blood CD4 positive lymphocyte count < 200/mm3

• Known liver disease due to causes other than nonalcoholic steatohepatitis with elevation of liver transaminases by more than two and a half times above the upper limits of normal (SGOT>105 U/L, SGPT>120 U/L) or total bilirubin (>1.5 mg/dL).

• Hematocrit of less than 30%.

• Current alcohol abuse (>7 drinks or 210 g per wk for women and >14 drinks or 420 g per wk for men).

• Current substance abuse.

• Uncontrolled diabetes mellitus with fasting plasma glucose > 180 mg/dL or hemoglobin A1c > 9%.

• History of weight loss during the last 3 months.

• Use of anorexiogenic drugs, thiazolidinediones, anabolic steroids and human growth hormone.

• Major Neuro-psychiatric illnesses impeding competence or compliance.

• Pregnant and lactating women.

• Cancer excluding skin cancer other than melanoma.

• Acute medical illnesses precluding participation in the studies.

• Chronic renal insufficiency with serum creatinine > 2 mg/dL.

• Untreated thyroid disorders such as hypothyroidism and hyperthyroidism. Each of the 4 treatment arms has additional specific inclusion and exclusion criteria