Effects of IGF-I in HIV Metabolic Disease

The University of Texas System (UT)

Status and phase: Terminated; Phase 1

Conditions: HIV Lipodystrophy

Treatments: Drug: mecasermin; Drug: Placebo control

Study type: Interventional

Funder types: Other

Identifiers

NCT01329744

1K23DK080644-01A1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

Recombinant IGF-I

Treatment:

Drug: mecasermin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo control