Effects of IGF-I in HIV Metabolic Disease

Phase 1

Terminated

• Conditions: HIV Lipodystrophy
• Interventions: Drug: mecasermin; Drug: Placebo control

• Registration Number: NCT01329744
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-06
• Study Start: 2011-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-22
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	mecasermin	Recombinant IGF-I
Placebo	Placebo control	-

Primary Outcome Measures

Name	Time	Method
Body composition	24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Glucose Homeostasis	24 weeks	Fasting glucose and insulin will be measured. A subset of patients will undergo a hyperinsulinemic clamp.

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States