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.

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