Effects of IGF-I in HIV Metabolic Disease

The main objectives of this study are the following:

1. Determine the effect of recombinant human insulin like growth factor-I (rhIGF-I)
(generic: mecasermin) on subcutaneous adiposity in patients with HIV lipodystrophy
syndrome.

2. Determine the effects of rhIGF-I on glucose homeostasis and lipids in patients with HIV
lipodystrophy.

3. Determine the effects of rhIGF-I on apoptosis, mitochondria, and inflammation, in
adipose tissue obtained from patients with HIV lipodystrophy.

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