The Use of Nutropin Depot in HIV-infected Adult Males

Withdrawn before enrolling · Phase 2/Phase 3

Conditions studied: HIV Infection

In brief

This is a pilot study. We will treat 10 HIV-infected adults (1/2 with lipoatrophy) with GH depot for one year. Results will be compared to data from 10 HIV patients (1/2 with lipoatrophy), treated with Nutropin AQ subcutaneously. The primary endpoint of the study is to determine the effect of GH depot on body weight and lean tissue mass (LTM). The secondary endpoints are to document changes in: 1) whole body protein turnover (WBPT), 2) gluconeogenesis, 3) bone mineral density and markers of bone turnover, 4) fat distribution (lipoatrophy), 5) thymus size, 6) T-cell subsets, and 7) TNF-µ levels. Adverse events, such as glucose intolerance and edema, will be monitored at every visit.

Key facts

Study ID

NCT00286676

Run by

University of Texas Southwestern Medical Center

People needed

0

Starts

2006-02-01

Expected to finish

2006-02-01

Last updated by the study team

2018-12-26

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• adult males ≥ 18 years of age
• mild to moderate lipoatrophy
• stable protease inhibitor therapy for at least six months.

You may not qualify if…

• Con-current supra-infection with acute illness defined by fever or bacterial culture
• malignancy
• females
• diabetes mellitus
• CNS tumors.

Where it is running

• Aston Ambulatory Care Center — Dallas, Texas, United States
• Parkland Health & Hospital System — Dallas, Texas, United States
• Veteran's Affairs Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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