The Use of Nutropin Depot in HIV-infected Adult Males
Status:
Withdrawn
Trial end date:
2006-02-01
Target enrollment:
Participant gender:
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-ยต levels. Adverse events, such
as glucose intolerance and edema, will be monitored at every visit.