ADULT AIDS CLINICAL TRIAL GROUP LONGITUDINAL LINKED RANDOMIZED TRIALS PROTOCOL

成人艾滋病临床试验组纵向连锁随机试验方案

• 批准号: 7378240
• 负责人: JUDITH Ann ABERG
• 金额: $ 25.08万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378240
• 关键词: ADULT; AIDS; CLINICAL; TRIAL; GROUP

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 cohortof HIV-infected individuals who have been prospectively randomized into approved parent AACTG 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 AACTG 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 AACTG 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 AACTG 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 AACTG clinical trials over time and still maintain participation in the ALLRT protocol, HIV-infected, antiretroviral treatment naive subjects and previously or currently treated subjects who are entered into parent AACTG clinical trials and who agree to be followed long-term for clinical, virologic, immunologic, and pharmacologic endpoints. Treatment regimens are determined according to randomized options available through participation in parent AACTG clinical trials. If a subject completes or terminates a parent AACTG clinical trial and does not immediately join another AACTG protocol, therapy, if continued, should be arranged independently of the A5001/ALLRT protocol. No treatment is provided through the ALLRT protocol.

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。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纵向和横断面队列HIV感染者，这些HIV感染者已被前瞻性随机分配至已批准的母公司AACTG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AACTG研究或在前8周内完成母临床试验。进入ALLRT方案的受试者可能需要收集额外的血液和数据用于临床、病毒学、免疫学和药理学评价。长期随访将在母AACTG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，如果达到其母方案的终点或其母方案参与以其他方式结束，并且无法立即参加替代AACTG随机试验或参与替代AACTG随机试验，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化AACTG临床试验，并仍保持参与ALLRT方案，HIV感染、抗逆转录病毒治疗初治受试者以及入组母AACTG临床试验并同意接受临床、病毒学、免疫学和药理学终点长期随访的既往或当前接受治疗的受试者。 治疗方案根据参与母公司AACTG临床试验获得的随机选择确定。如果受试者完成或终止母AACTG临床试验，并且没有立即加入另一项AACTG方案，如果继续治疗，则应独立于A5001/ALLRT方案安排治疗。ALLRT方案不提供治疗。