ACTG A5073 COMPARE ANTIRETROVIRAL THERAPY & SELF-ADMINISTERED & OBSERVED THERAPY

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。A5073是一项随机、II期、开放标签、48周、多中心试验，共有375例受试者参加，旨在比较强效多药联合抗逆转录病毒治疗方案的两种剂量方案的抗逆转录病毒疗效。在一个组中，方案的一种组分将每日两次给药（BID，A组），在另一个组中，所有组分将每日一次给药（QD，B组）。A5073还试图通过比较相同QD方案的两种治疗策略来确定直接观察治疗（DOT）对抗逆转录病毒疗效的影响：研究前24周的常规自我给药治疗（B组）或直接观察治疗（DOT，C组）。第24周后，C组受试者将自我给予所有研究药物直至第48周，以检查DOT可能的训练效应。在整个研究期间，将经常测量血浆HIV-1 RNA水平。其他结局指标将包括安全性和耐受性;生活质量和依从性指标;以及CD 4+和CD 8 + T细胞应答。将对所有受试者进行群体药代动力学（PK）研究。将在整个研究期间使用电子药物监测系统测量依从性。随机分配至C组的受试者将按照周一至周五的时间表接受每日一次研究药物给药，并将在周末和节假日自行给药。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. A5073 is a randomized, phase II, open-label, 48-week, multicenter trial of 375 subjects, designed to compare the antiretroviral efficacy of two dose schedules of a potent multi-drug combination antiretroviral regimen. In one arm one component of the regimen will be given twice daily (BID, arm A) and in another arm, all components will be given once daily (QD, arm B). A5073 also seeks to determine the effect of directly observed therapy (DOT) on antiretroviral efficacy by comparing two treatment strategies for the same QD regimen: conventional, self-administered therapy (arm B) or directly observed therapy (DOT, arm C) for the first 24 weeks of the study. After week 24, subjects in arm C will self-administer all study medications through week 48 in order to examine for a possible training effect of DOT. Plasma HIV-1 RNA levels will be measured frequently throughout the study. Additional outcome measures will include safety and tolerance; quality of life and adherence indicators; and CD4+ and CD8+ T-cell responses. Population pharmacokinetics (PK) will be performed on all subjects. Adherence will be measured throughout the study using an electronic drug monitoring system. Subjects randomized to arm C will be observed for their once daily dose of study medications on a Monday-Friday schedule, and will self-administer the weekend and holiday doses.