This is a double blind, randomized, comparison trial of 12 weeks duration. Subjects will be randomized to receive either the combination of megestrol acetate and testosterone enanthate or megestrol acetate plus testosterone enanthate placebo. All subjects who successfully complete the double blind phase will be eligible to receive the combination of mefestrol acetate and testosterone enanthate as open label therapy for an additional 12 weeks. The primary objective of this trial is to test the hypothesis that the predominant accrual of fat rather than lean body mass that occurs during treatment fo HIV-associated wasting with megestrol acette may be ameliorated by treatment with megestrol acetate and testosterone enanthate in combination. The secondary objectives are as follows: 1) to compare the effects of megestrol acetate and testosterone enanthate in combination to those of megestrol acetate plus testosterone enanthate placebo on energy intake, body weight, and quality of life. 2) to compare the effects of megestol acetate and testosterone enanthate in combination to those of megestrol acetate on the pituitary adrenal axis. 4) to evaluate the safety of megestrol acetate and testosterone enanthate in combination and megestrol acetate plus testosterone enanthate placebo.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000750-27S1
Application #
6291044
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
27
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Type
DUNS #
005436803
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
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