PHASE I STUDY OF TESTODERMR-TTS IN HYPOGONADAL MALES WITH/WITHOUT AIDS

Testoderm C-95-046研究是一项药物的药代动力学（PK）研究， 含有雄性激素睾酮的透皮贴剂， 阳性和HIV阴性男性，通过测量 血清睾酮PK研究是一项伴随研究， 在基线和28天结束时测量血清睾酮 受试者佩戴透皮贴剂的时间段。 一 研究的第二部分测量了另外28天后的血清睾酮 用药天数。 该药物以透皮贴剂的形式给药 戴在阴囊上每天更换 研究的前2天 （基线和治疗第一天）在GCC住院， 在此期间进行了仔细的身体检查，12 采集血样，作为药代动力学数据的一部分 收藏. 然后指导患者使用贴片， 送回家自我管理。 患者返回诊所的天数 7号14号和21号做更多的血液检查。 患者再次入院， 在研究的第27天进行GCC，用于尿液和血液测试（16名血液样本）。 样品）。 生活质量问卷在两个年龄段都填写。 第一次和第二次GCC住院治疗。 临床评价，包括 在门诊患者中， 第42和56天的门诊。 在第56天，研究的最后一天， 还进行了体格检查。 这项研究的潜在意义在于， 不像其他激素控制和患者独立营养 (e.g., TPN），增加瘦体重的艾滋病毒感染和浪费的病人， 而不是脂肪。 这一点很重要，因为我们意识到需要 解决代谢功能失调，研究表明， 常见于晚期HIV感染和艾滋病。 此外，睾丸激素 似乎有助于增加幸福感。 C-95-012的结果：在全国范围内，124名男性，平均体重减轻7% 的体重，被招募。 睾丸激素补丁有效地 血清睾酮水平升高，伴随FSH降低 和LH水平，正如预期 不幸的是，体重或瘦肉的变化 体重未达到统计学显著性。 生活质量 性功能的测量和测量也没有差异， 安慰剂和治疗。 HIV病毒载量无差异 安慰剂组和治疗组之间， 不良事件。 进行样本量计算以提供90%的功效 检测体细胞质量变化的2.0 kg差异， 基线。 对体细胞进行协变量和亚组分析 使用变量CD 4、总睾酮和游离睾酮、使用 蛋白酶抑制剂和机会性感染史。 没有 在协变量分析中观察到效应， 观察各亚组。 继续分析，揭盲 研究（C-95-013）和PK研究正在进行中。

The Testoderm C-95-046 Study was a pharmacokinetic (PK) study of a transdermal patch containing the male hormone, testosterone, in HIV- positive and HIV-negative males, who were hypogonadal by measurement of serum testosterone. The PK study was a companion study designed to measure the serum testosterone at baseline, and at the end of a 28 day time period during which participants wear the transdermal patch. A second part of the study measured serum testosterone after another 28 days of medication usage. The drug was given as a transdermal patch worn on the scrotum, and changed daily. The first 2 days of the study (baseline and day one of therapy) were spent as an inpatient in the GCC, during which time a careful physical examination was performed, and 12 blood samples were obtained, as part of the pharmacokinetic data collection. Patients were then instructed in use of the patches and sent home for self-administration. Patients returned to clinic on days 7, 14 and 21 for more blood tests. Patients were again admitted to the GCC on day 27 of the study, for urine and blood testing (16 blood samples). A quality of life questionnaire was filled out at both the first and the second GCC inpatient stay. Clinic evaluations, consisting of a brief evaluation and blood sampling, occurred in the outpatient clinic on days 42 and 56. On day 56, the final day of the study, a physical exam was also performed. The study's potential significance lies in the fact that testosterone, unlike other hormonal manipulations and patient-independent nutrition (e.g., TPN), adds lean body mass to HIV-infected and wasted patients, rather than fat. This is important as we become aware of the need to address the dysfunctional metabolism that studies have now shown to be common in advanced HIV-infection and AIDS. In addition, testosterone appears to contribute to an increased sense of well-being. Results of C-95-012: Nationally, 124 men, with a mean weight loss of 7% of body mass, were enrolled. The Testoderm patches effectively increased serum testosterone levels, with concomitant decrease in FSH and LH levels, as expected. Unfortunately, changes in weight or lean body mass did not reach statistical significance. Quality of life measures and measures of sexual function were also not different between placebo and treatment. There were no differences in HIV viral load between placebo and treatment groups, and no relevant differences in adverse events. Sample size calculations were done to provide 90% power to detect a difference of 2.0 kg in the change in body cell mass from baseline. Co-variate and subgroup analyses were performed for body cell mass using the variables CD4, total and free testosterone, use of protease inhibitor, and history of opportunistic infections. No effects were observed in the co-variate analysis and no differences in the subgroups were observed. Analysis of the continuation, unblinded study (C-95-013) and the PK study are underway.