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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 ALLRT方案是一系列计划的前瞻性荟萃分析和跨方案分析，数据收集自已建立的HIV感染者纵向和横断面队列，这些HIV感染者已被前瞻性随机分配至已批准的母公司ACTG临床试验，并同意长期随访，以评价临床、病毒学、免疫学、以及与长期强效抗逆转录病毒治疗相关的药理学结果。 最初入组ALLRT方案的所有受试者将同时参与母ACTG研究或在前8周内完成母临床试验。 入组ALLRT方案的受试者可能需要采集额外的血液和数据，用于临床、病毒学、免疫学和药理学评价。 长期随访将在ACTG母方案的背景下继续进行，直至这些研究结束或达到终点。 对于进入ALLRT方案的受试者，如果达到了其母方案的终点，或者其母方案参与以其他方式结束，并且对于其参与替代ACTG随机试验不是立即可用或可行的，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。 受试者随后可随时间推移入组额外的随机ACTG临床试验，并仍保持参与ALLRT方案，研究访视时间尽可能一致。