ACTG A5001 - AIDS LONGITUDINAL LINKED RANDOMIZED TRIALS

ACTG A5001 - 艾滋病纵向连锁随机试验

• 批准号: 7604800
• 负责人: JEFFERY L MEIER
• 金额: $ 1万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604800
• 关键词: AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Address; Anti-Retroviral Agents; Clinical Data; Clinical Trials; Collection; Computer Retrieval of Information on Scientific Projects Database; Data; Databases; Elements; End Point; Enrollment; Funding; Grant; Immune; Immunologics; Individual; Institution; Intervention; Link; Parents; Protocols documentation; Randomized; Randomized Controlled Clinical Trials; Regimen B; Research; Research Personnel; Resources; Source; Testing; Time; Treatment Protocols; United States National Institutes of Health; Upper arm; antiretroviral therapy; base; cohort; design; prospective

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 ALLRT 方案将建立一个前瞻性、纵向关联的随机试验队列，由随机分配到 AACTG 或 PACTG 临床试验中选定的抗逆转录病毒疗法、基于免疫的疗法或抗 HIV 干预管理策略的受试者组成。 登记的受试者可以在数据库中进行分层，从而允许跨协议分析来解决特定的长期科学问题。 登记的受试者可以为多项分析贡献数据。 将初始受试者共同纳入 ALLRT 方案的母体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、治疗转换或其他规定的时间间隔时为登记受试者收集明确的病毒学、免疫学和临床数据； 3) 为达到终点的受试者（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）前瞻性建立滚动选项，或计划跟踪无法使用滚动选项的受试者； 4) 适合解决长期科学目标的设计。 个别亲本研究测试的具体假设和解决的科学问题（例如，在先前接受方案 C 治疗的受试者中，方案 A 与方案 B 相比如何）将保留在亲本研究中，但这些亲本研究的数据和结果将在 ALLRT 方案内更广泛的跨方案分析中进行检查，从而允许在多个随机研究中提出长期问题。