drugset / Trial / NCT00286676

The Use of Nutropin Depot in HIV-infected Adult Males

NCT00286676

Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2006-02-01
Primary completion
2006-02-01
Completion
2006-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Somatropin Protein / enzyme biologic Subcutaneous