Effects of IGF-I in HIV Metabolic Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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The main objectives of this study are the following: Determine the effect of recombinant human insulin like growth factor-I (rhIGF-I) (generic: mecasermin) on subcutaneous adiposity in patients with HIV lipodystrophy syndrome. Determine the effects of rhIGF-I on glucose homeostasis and lipids in patients with HIV lipodystrophy. Determine the effects of rhIGF-I on apoptosis, mitochondria, and inflammation, in adipose tissue obtained from patients with HIV lipodystrophy.

Official Title
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Effects of Recombinant IGF-I in HIV Associated Metabolic Disease

Conditions
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HIV Lipodystrophy

Intervention / Treatment
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* Drug: mecasermin
* Drug: Placebo control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Recombinant IGF-I | Drug: mecasermin<br>* a subcutaneous injection twice a day<br>* Other names: Increlex;|
| Placebo Comparator: Placebo<br> | Drug: Placebo control<br>* Subcutaneous injection given twice per day of placebo compound, for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Participants will have a body scan called a dual energy x-ray absorptiometry (DEXA) scan and a single slice abdominal CT scan and mid thigh scan to measure subcutaneous and internal fat. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Homeostasis | Fasting glucose and insulin will be measured. A subset of patients will undergo a hyperinsulinemic clamp. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV lipodystrophy