NCT00100698

Physiologic Growth Hormone Effects in HIV Lipodystrophy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat. Secondary endpoints will include measures of insulin-like growth factor-1 (IGF-1), glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters.

Detailed description

This study will investigate long-term, low-dose growth hormone administration in HIV-infected patients with reduced growth hormone (GH) secretion and increased visceral adiposity. We hypothesize that low-dose growth hormone will reduce visceral fat preferentially over subcutaneous fat, and increase lean body mass. Secondary endpoints will include measures of IGF-1, glucose homeostasis, lipids, blood pressure,bone density, cardiovascular risk and safety parameters. Dosing of growth hormone will be based on patients' IGF-1 levels and will not exceed 6mcg/kg/day.

Conditions

• AIDS
• HIV Infections

Interventions

Type	Name	Description
DRUG	recombinant human growth hormone	growth hormone dosed by weight and IGF-1 level,subcutaneously once a day, 18 months
DRUG	placebo	placebo subcutaneously once a day, 18 months

Timeline

• Start date: 2004-01-01
• Primary completion: 2007-10-01
• Completion: 2009-04-01
• First posted: 2005-01-05
• Last updated: 2010-07-27
• Results posted: 2010-07-22

Locations

1 site across 1 country: United States