PHASE II TRIAL OF MEGESTROL ACETATE AND TESTOSTERONE IN HIV WASTING

这是一项为期12周的双盲随机对照试验。受试者将被随机接受甲地孕酮和醋酸睾丸酮的联合治疗，或甲地孕酮和醋酸睾丸酮联合服用安慰剂。所有成功完成双盲阶段的受试者都将有资格接受甲非司酮和庚酸睾丸酮的联合治疗，作为开放标签治疗，再持续12周。这项试验的主要目的是验证这样一种假设，即在使用甲地孕酮治疗HIV相关的消瘦过程中，主要积累的脂肪而不是瘦体重可以通过联合使用甲地孕酮和庚酸睾丸酮来改善。次要目标如下：1)比较甲地孕酮和醋酸睾丸酮联合用药和甲地孕酮加醋酸睾丸酮安慰剂对能量摄入、体重和生活质量的影响。2)比较甲地孕醇、醋酸睾丸酮与甲地孕酮合用对垂体肾上腺轴的影响。4)评价甲地孕酮与醋酸睾丸酮配伍与安慰剂甲地孕酮配伍的安全性。

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.