PHASE II TRIAL OF MEGESTROL ACETATE AND TESTOSTERONE IN HIV WASTING

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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 of 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.