Randomized, controlled trial of recombinant IGF-I for HIV lipodystrophy

Study ID
STU 082010-311

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Roy Kim

roy.kim@utsouthwestern.edu

Principal Investigator
Roy Kim

Summary

This is a randomized, placebo controlled trial of recombinant IGF-I (generic: mecasermin) in HIV lipodystrophy. Eighteen adults with HIV infection and lipodystrophy will be randomized to placebo or twice daily subcutaneous injection of IGF-I. Each subject will be treated for 24 weeks. At week 0 and week 24, subjects will undergo assessments including fasting blood sample, dual energy x-ray absorptiometry, limited computed tomography of abdomen, and subcutaneous fat biopsy.

Participant Eligibility

1. HIV positive with suppressed viral loads on 2 consecutive tests. Suppression is defined as less than 100 copies/mL by bDNA or ultrasensitive PCR
2. Age 18-65 years inclusive. Subjects may be of any race and either gender
3. No change in antiretrovirals for 3 months
4. At least one feature of the lipodystrophy syndrome consisting of one of the following:
i.) Evidence of lipoatrophy in the face, limbs, or gluteal areas*
ii) Dyslipidemia defined on a fasting blood sample as
Triglycerides > 200 OR
HDL cholesterol < 40 mg/dL OR
Normal lipids while on lipid lowering therapy
iii) Abnormal glucose homeostasis (but not diabetes) defined as:
Fasting hyperinsulinemia greater than or equal to 20uU/mL OR
Fasting glucose greater than or equal to 100mg/dL
5. Subjects are capable of giving informed consent