TESTOSTERONE REPLACEMENT THERAPY IN HIV-POSITIVE MEN

亚综合征水平的抑郁症状和低能量在 晚期HIV疾病。内分泌和代谢异常也会发生。 据报道，其中睾丸素缺乏是最常见的 很普通。因为睾酮既是一种雄激素，也是一种合成代谢物质 (体重调节)荷尔蒙，可能与低体重有关 睾酮、性功能障碍、低能量和代谢紊乱 以及抑郁的情绪。我们推测这个症状群代表着 一种睾酮缺乏综合征，并建议评估睾酮 替代疗法。 随着艾滋病患者寿命的延长，生活质量问题日益突出 被公认为显著的。坊间报道表明，睾丸激素 晚期HIV疾病的替代疗法不仅恢复性欲 和性功能，但能增强情绪、精力和食欲。通过 鼓励坚持医疗方案(在后期往往是艰难的 疾病)，这些改善也可能提高寿命。 我们希望评估睾酮替代治疗对情绪低落的影响。 对患有进行性艾滋病毒疾病的男性的治疗，临床上存在缺陷 睾丸激素水平和性功能障碍。相关功能包括 低能量和低食欲/体重下降。治疗分为两个阶段。这个 第一种是开放治疗，为期12周，每两周肌肉注射一次 注射仓库睾丸酮酯，血清水平评估为一 每次注射后一周。在第二阶段，第12周的应答者是随机的 安慰剂或维持剂被分配为双盲停药 活跃的睾丸素。结果衡量标准包括12周应答率 自我报告和临床医生判断以及相对复发率 在双盲停止阶段之后。情绪，性，精力和 食欲变化以及治疗后会出现的不良反应 在基线时评估，此后每两周评估一次。力量(握手)和 营养状况(身体成分)以及身体、内分泌 测量和T细胞亚群将在基线、第12周和 研究终点出于安全考虑和确定 这些指标的变化与临床结果相关。这个 拟议的研究旨在确定一种实用的和临床上有用的 社区环境的待遇。

Depressive symptoms at subsyndromal levels and low energy are common in late stage HIV illness. Endocrine and metabolic abnormalities also occur frequently, of which testosterone deficiency is reportedly the most common. Since testosterone is both an androgenic (virilizing) and anabolic (weight regulating) hormone, there may be a connection between low testosterone, sexual dysfunction, low energy and metabolic disorder as well as depressed mood. We postulate that this symptom cluster represents a testosterone deficiency syndrome and propose to assess testosterone replacement therapy. As people with AIDS live longer, quality of life issues are increasingly recognized as salient. Anecdotal reports suggest that testosterone replacement therapy in later stage HIV illness not only restores libido and sexual function, but enhances mood, energy and appetite. By encouraging adherence to medical regimens (often arduous in late stage illness) these improvements may promote duration of life as well. We wish to assess the effects on low mood of testosterone replacement therapy, in men with progressive HIV illness, clinically deficient testosterone levels, and sexual dysfunction. Associated features include low energy and low appetite/weight loss. Treatment has two phases. The first consists of open treatment for 12 weeks with biweekly intramuscular injections of depot testosterone ester, with serum levels assessed one week after each injection. In Phase 2, responders at Week 12 are randomly assigned to double blind discontinuation by placebo or maintenance on active testosterone. Outcome measures include Week 12 response rate by self report and clinician judgement as well as relative relapse rates after the double blind discontinuation phase. Mood, sexual, energy and appetite changes as well as treatment emergent adverse reactions will be assessed at baseline and biweekly thereafter. Strength (hand grip) and nutritional status (body composition) as well as physical, endocrine measures and T cell subsets will be assessed at baseline, Week 12 and study endpoint both for safety considerations and to determine whether changes in these measures are associated with clinical outcome. The proposed study is meant to identify a practical and clinically useful treatment for community settings.