ACTG A5001 - AIDS LONGITUDINAL LINKED RANDOMIZED TRIALS

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。所列机构为中心机构，不一定为研究者机构。ALLRT方案将建立一个前瞻性、纵向联系的随机试验队列，由随机分配至AACTG或PACTG临床试验中选定的抗逆转录病毒治疗、基于免疫的治疗或抗HIV干预管理策略的受试者组成。入组的受试者可以在数据库中分层，以允许跨方案分析解决特定的长期科学问题。入组的受试者可能为多项分析提供数据。将初始受试者共同入组ALLRT方案的母临床试验将包含以下要素：1）提供随机、抗逆转录病毒治疗、基于免疫的治疗或抗HIV干预管理策略; 2）在每次随机化、治疗转换时收集明确定义的病毒学、免疫学和临床数据，或入组受试者的其他规定时间间隔; 3）为达到终点的受试者前瞻性建立展期选项，例如，治疗失败或对方案组中的初始药物产生治疗限制性不耐受的受试者，或对无法获得滚动选择的受试者进行随访的计划;以及4）适合于解决长期科学目标的设计。 个别母研究所检验的具体假设和解决的科学问题（例如，方案A与方案B在既往接受方案C）治疗的受试者中的比较结果将保留在母研究中，但这些母研究的数据和结果将在ALLRT方案中更广泛的跨方案分析中进行检查，允许在多项随机研究中提出长期问题。

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. The ALLRT protocol will establish a prospective, longitudinal linked randomized trial cohort consisting of subjects randomly assigned to selected antiretroviral therapies, immune-based therapies, or strategies for management of anti-HIV interventions in AACTG or PACTG clinical trials. Enrolled subjects can be stratified in the database in a manner that will allow cross-protocol analyses to address specific long-term scientific questions. Enrolled subjects may contribute data to multiple analyses. Parent clinical trials from which initial subjects will be co-enrolled in the ALLRT protocol will be those that incorporate the following elements: 1) the provision of randomized, antiretroviral treatment, immune-based therapies, or strategies for the management of anti-HIV interventions; 2) collection of well-defined virologic, immunologic, and clinical data at the time of each randomization, treatment switch, or other defined interval for enrolled subjects; 3) the prospective establishment of rollover options for subjects who reach endpoints, e.g., who fail treatment or who develop a treatment-limiting intolerance to the initial agents in a protocol arm, or a plan to follow subjects for whom roll-over options are not available; and 4) a design for which long-term scientific objectives are appropriate to address. Specific hypotheses tested and scientific questions addressed by individual parent studies (e.g., how does regimen A compare to regimen B in subjects previously treated with regimen C) will be preserved in the parent studies, but data and findings from these parent studies will be examined in broader cross-protocol analyses within the ALLRT protocol, allowing long-term questions to be asked across multiple, randomized studies.