DHEA EFFECTS ON MOOD IN DEPRESSED HIV+ PATIENTS

这是一项抗抑郁药的双盲、安慰剂对照临床试验。 脱氢表雄酮在HIV阳性个体中的作用次要目标包括 脱氢表雄酮是否具有合成代谢作用或促雄激素作用 对登记受试者的影响。调查人员将考虑基本的 研究对象肾上腺类固醇代谢的内分泌学，并建议 评估脱氢表雄酮对免疫状态和病毒活性的影响 艾滋病毒感染者使用脱氢表雄酮的安全性。 这项研究是一项为期八周的口服脱氢表雄酮与非脱氢表雄酮的双盲对照试验。 安慰剂，药物响应者的维持期为8周，16周 提供给安慰剂无反应者的开放治疗(八周后 双盲试验)。他们提出了1：1的随机化方案，并预测114 注册的个人将完成为期八周的试验。如果脱氢表雄酮有所改善 抑郁症状，以及提高性欲和减少肌肉损失 弥撒，那么调查人员就会确定一个广泛的干预 适用于感染艾滋病毒的男性和女性的行动范围，即 实用、便宜、易用。 关于内分泌研究，调查人员将评估前体 以及口服该化合物前后DHEA的代谢物， 并检查皮质醇、甘油三酯、胰岛素、胆固醇、生长的影响 激素、IGF-1和IGF-1结合蛋白。测试将在研究期间进行 基线、第4周和第8周，包括标准剂量ACTH、低剂量ACTH、CRF和 促性腺激素释放激素刺激试验评估下丘脑-垂体-肾上腺和 脱氢表雄酮治疗前后下丘脑-垂体性腺功能的变化。 这将使调查人员能够评估潜在的潜在机制 关于脱氢表雄酮对情绪、性欲和身体的潜在疗效 组成。

This is a double blind, placebo-controlled clinical trial of the antidepressant effect of DHEA among HIV+ individuals. Secondary goals will include determination of whether DHEA has anabolic effects or androgenic effects on enrolled subjects. The investigators will consider the basic endocrinology of adrenal steroid metabolism in the subjects, and propose to assess the effects of DHEA on immune status and viral activity with regard to the safety of the use of DHEA in HIV infected individuals. The study is an eight week double blind controlled trial of oral DHEA vs. placebo with an eight week maintenance phase for drug responders, and 16 weeks of open treatment offered to placebo non-responders (after the eight week double blind trial). They propose a 1:1 randomization and predict that 114 enrolled individuals will complete the eight week trial. If DHEA ameliorates depressive symptoms, as well as increasing libido and reducing loss of muscle mass, then the investigators will have identified an intervention with a broad spectrum of action suitable for both men and women with HIV infection, that is practical, inexpensive, and accessible. With regard to the endocrine studies, the investigators will assess precursors and metabolites of DHEA before and after oral administration of the compound, and examine effects of cortisol, triglycerides, insulin, cholesterol, growth hormone, IGF-1, and IGF-1 binding proteins. Tests will be administered at study baseline, weeks 4 and 8, including standard dose ACTH, low dose ACTH, CRF, and GNRH stimulation tests to assess the hypothalamic-pituitary-adrenal and hypothalamic-pituitary gonadal function before and after DHEA administration. This will permit the investigators to assess potential underlying mechanisms for the putative therapeutic effects of DHEA on mood, libido, and body composition.