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PHASE II TRIAL OF MEGESTROL ACETATE AND TESTOSTERONE IN HIV WASTING

醋酸甲地孕酮和睾酮治疗 HIV 消瘦的 II 期试验

基本信息

批准号：
6291170
负责人：
JOSEPH WHEAT
金额：
$ 0.04万
依托单位：
INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
起止时间：
1998-12-01 至 1999-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/6291170
关键词：
AIDS AIDS therapy acetates bioenergetics body weight cachexia clinical research combination chemotherapy drug adverse effect drug screening /evaluation human subject human therapy evaluation pituitary adrenal axis placebos quality of life testosterone

项目摘要

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.

这是一项为期12周的双盲、随机、比较试验。受试者将随机接受醋酸甲地孕酮和庚酸睾酮联合治疗或醋酸甲地孕酮加庚酸睾酮安慰剂治疗。成功完成双盲期的所有受试者将有资格接受醋酸甲雌酚和庚酸睾酮的组合作为额外12周的开放标签治疗。本试验的主要目的是检验以下假设：醋酸甲地孕酮治疗HIV相关性消瘦期间发生的脂肪而非瘦体重的主要增加可通过醋酸甲地孕酮和庚酸睾酮联合治疗得到改善。次要目的如下：1）比较醋酸甲地孕酮和庚酸睾酮联合给药与醋酸甲地孕酮+庚酸睾酮安慰剂对能量摄入、体重和生活质量的影响。 2)比较醋酸甲地孕酮和庚酸睾酮联合用药与醋酸甲地孕酮对垂体肾上腺轴的作用。 4)评价醋酸甲地孕酮和庚酸睾酮联合用药和醋酸甲地孕酮+庚酸睾酮安慰剂的安全性。