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: 7605681
• 负责人: JUDITH Ann ABERG
• 金额: $ 26.34万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605681
• 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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 AllRT方案是一系列计划的前瞻性荟萃分析和跨方案分析，从已建立的纵向和横截面同伴收集的数据进行了分析，这些数据是由HIV感染的个体进行的，这些个体已被前瞻性地随机地随机地随机地随机地与临床学的长期治疗，并同意进行临床学，并同意进行长期的临床学，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，病毒性，并同意。有效的抗逆转录病毒疗法。 最初进入ALLRT协议的所有受试者将同时参加父母AACTG研究，或者在过去8周内完成了父母临床试验的参与。 进入ALLRT方案的受试者可能会有额外的血液和数据收集，以进行临床，病毒，免疫学和药理评估。 长期随访将在父级AACTG方案的背景下继续进行，直到达到关闭或达到终点为止。 对于进入AllRT协议的受试者，他们在其父协议或母公司协议参与方面的终结点否则就结束了，并且没有立即提供替代AACTG随机试验，或者可行，可行的，长期的长期随访，以临床，病毒，免疫学和药理性监测，将根据AllRT协议中列出的时间表继续进行。随后，受试者可能会随着时间的流逝而进行其他随机AACTG临床试验，并仍保持参与ALLRT方案，HIV感染，抗逆转录病毒治疗幼稚的受试者以及以前或目前治疗的受试者，这些受试者已被纳入父级AACTG临床试验，并同意长期遵循临床，病毒，病毒，免疫，免疫学，免疫学和药物学和药物学的终点。 根据参与父级AACTG临床试验获得的随机选择确定治疗方案。 如果受试者完成或终止父母AACTG临床试验，并且不立即加入另一AACTG方案（如果继续），则应独立于A5001/ALLRT方案进行安排。 通过Allrt方案未提供治疗。