NCT01329744

Effects of IGF-I in HIV Metabolic Disease

Effects of Recombinant IGF-I in HIV Associated Metabolic Disease

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Lipodystrophy

Interventions

Type	Name	Description
DRUG	mecasermin	a subcutaneous injection twice a day
DRUG	Placebo control	Subcutaneous injection given twice per day of placebo compound, for 24 weeks

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-04-06
• Last updated: 2016-03-23

Locations

1 site across 1 country: United States