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: 7718385
• 负责人: JUDITH Ann ABERG
• 金额: $ 39.81万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 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 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718385
• 关键词: AIDS clinical trial group; Adult; Anti-Retroviral Agents; Blood; Clinical; Clinical Trials; Clinical Trials Cooperative Group; 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; Treatment Protocols; United States National Institutes of Health; Week; antiretroviral therapy; 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 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。子项目及 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 方案是一系列计划中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，这些个体已被前瞻性随机分配到已批准的母体 AACTG 临床试验中，并且已同意进行长期随访，以评估与有效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与母体 AACTG 研究或在之前 8 周内完成参与母体临床试验。 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。 长期随访将在父级 AACTG 方案的背景下继续进行，直到这些研究结束或达到终点。 对于进入 ALLRT 方案的受试者，如果达到其母方案的终点，或者其母方案的参与结束，并且参与替代 AACTG 随机试验不能立即获得或不可行，则需要进行临床、病毒学长期随访、免疫学和药理学监测将根据 ALLRT 方案中概述的时间表继续进行。随着时间的推移，受试者可以随后参加额外的随机 AACTG 临床试验，并且仍然继续参与 ALLRT 方案、HIV 感染者、未接受过抗逆转录病毒治疗的受试者以及之前或当前接受过治疗的受试者，这些受试者已进入母体 AACTG 临床试验并同意长期随访-临床、病毒学、免疫学和药理学终点的术语。 治疗方案是根据参与 AACTG 母体临床试验获得的随机选择来确定的。 如果受试者完成或终止母体 AACTG 临床试验并且没有立即加入另一个 AACTG 方案，则治疗（如果继续）应独立于 A5001/ALLRT 方案进行安排。 ALLRT 方案不提供任何治疗。