ACTG A5001 - LONGITUDINAL LINKED RANDOMIZED TRIALS (ALLRT) PROTOCOL

ACTG A5001 - 纵向连锁随机试验 (ALLRT) 方案

• 批准号: 7719419
• 负责人: THOMAS A CAMPBELL
• 金额: $ 4.22万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7719419
• 关键词: AIDS clinical trial group; Blood; Clinical; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Data; Data Analyses; End Point; Enrollment; Evaluation; Funding; Grant; Immunologics; Individual; Institution; Link; Meta-Analysis; Monitor; Outcome; Parents; Protocols documentation; Purpose; Randomized; Randomized Controlled Clinical Trials; Research; Research Personnel; Resources; Schedule; Series; Source; Time; United States National Institutes of Health; Visit; Week; antiretroviral therapy; cohort; follow-up; 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 is a planned series of prospective meta-analyses and cross-protocol analyses of data to be collected from an established longitudinal and cross-sectional cohort of HIV-infected individuals who have been prospectively randomized into approved parent ACTG clinical trials, and who have agreed to be followed long-term for the purpose of evaluating clinical, virologic, immunologic, and pharmacologic outcomes associated with long-term treatment with potent antiretroviral therapies. All subjects initially entered into the ALLRT protocol will be participating concurrently in a parent ACTG study or have completed participation in a parent clinical trial within the previous 8 weeks. Subjects entered into the ALLRT protocol may have additional blood and data collected for clinical, virologic, immunologic, and pharmacologic evaluations. Long-term follow-up will continue within the context of parent ACTG protocols until those studies close or an endpoint is reached. For subjects entered into the ALLRT protocol who reach an endpoint on their parent protocol or their parent protocol participation otherwise ends, and for whom participation in an alternative ACTG randomized trial is not immediately available or feasible, long-term follow-up with clinical, virologic, immunologic, and pharmacologic monitoring will continue according to the schedule outlined in the ALLRT protocol. Subjects may subsequently enroll in additional randomized ACTG clinical trials over time and still maintain participation in the ALLRT protocol, with study visits timed to coincide as nearly as possible.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 ALLRT方案是一系列计划中的前瞻性荟萃分析和交叉方案分析，将从HIV感染者的既定纵向和横断面队列中收集数据，这些人群已被前瞻性随机纳入经批准的父母ACTG临床试验，并同意接受长期跟踪，目的是评估与有效的抗逆转录病毒疗法长期治疗相关的临床、病毒学、免疫学和药理学结果。最初进入ALLRT方案的所有受试者将同时参加父母ACTG研究或在过去8周内完成父母临床试验。进入ALLRT方案的受试者可能会收集额外的血液和数据，用于临床、病毒学、免疫学和药理学评估。长期随访将在父母ACTG方案的范围内继续进行，直到这些研究结束或达到终点。对于进入ALLRT方案的受试者，如果他们到达其父方案或其父方案的终点，否则参与替代的ACTG随机试验不能立即获得或不可行，则将根据ALLRT方案中概述的时间表继续进行临床、病毒学、免疫学和药理学监测的长期随访。受试者随后可以随着时间的推移加入额外的随机ACTG临床试验，并仍然参与ALLRT方案，研究访问的时间安排尽可能地一致。