Effects of IGF-I in HIV Metabolic Disease

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study examines the effects of recombinant insulin like growth factor - I on body composition, glucose homeostasis, and lipids, in adults with HIV infection and signs of metabolic disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Mecasermin

Criteria

Inclusion Criteria:

• HIV positive with undetectable viral load

• No change in antiretrovirals for 3 months

• Evidence of lipoatrophy in the limbs, and face or gluteal area

• Dyslipidemia defined as:

• Fasting triglycerides > 200 OR

• HDL cholesterol < 40 mg/dL

• Abnormal glucose homeostasis defined as:

• Fasting hyperinsulinemia > 20 uU/mL OR

• Fasting glucose 100-125 mg/dL, inclusive

Exclusion Criteria:

• Two consecutive viral >75 or > 50 copies/mL using the tests listed above

• Presence of AIDS wasting

• Change in antiretroviral medication (not dose) in the prior 3 months

• Coronary artery disease, cerebrovascular, or peripheral arterial disease

• Diabetes mellitus

• Adrenal insufficiency, hypoglycemia, thyroid disease, or other endocrine disorder that is untreated

• Malignancy

• Eating disorder

• Pregnancy (urine pregnancy test is required of all females)

• Previous liposuction or bariatric surgery

• Other systemic conditions or other disorders at the discretion of the investigators

• Current use of systemic glucocorticoids, or other agent affecting body weight or glucose homeostasis or other drug at the discretion of the investigators

• Use of interferon within the past six months

• Use of insulin, insulin secretagogue, thiazolidinedione, or metformin in the prior 3 months

• Initiation or dose adjustment, within the prior 3 months, of any of the following drugs or drug classes: fibrate, cholesterol binding resin, statin, niacin, or omega 3 fatty acid (fish oil).

• Use of uridine, growth hormone, IGF-I, and growth hormone releasing factor analogues