PACTG 390: ANTIRETROVIRAL REGIMENS AND TREATMENT-SWITCHING STRATEGIES (AIDS)

PACTG 390：抗逆转录病毒治疗方案和治疗转换策略（艾滋病）

• 批准号: 7605729
• 负责人: William Borkowsky
• 金额: $ 1.1万
• 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/7605729
• 关键词: AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Address; Age; Age-Years; American; Anti-Retroviral Agents; Child; Childhood; Computer Retrieval of Information on Scientific Projects Database; Enrollment; European; Exposure to; Funding; Grant; Institution; Label; Measures; Nuclear; Perinatal Exposure; Phase; Protease Inhibitor; Randomized; Relapse; Research; Research Personnel; Resources; Reverse Transcriptase Inhibitors; Site; Source; Stratification; Treatment Protocols; United States National Institutes of Health; Upper arm; Viral Load result; antiretroviral therapy; day; experience

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. This is a phase II/III randomized, open-label study of combination antiretroviral regimens and treatment-switching strategies in antiretroviral na¿ve children >30 days and <18 years of age. This pediatric ACTG (AIDS) study will address two major questions: 1) Is initial antiretroviral therapy consisting of 2 nuclear reverse transcriptase inhibitors (NRTI) plus a protease inhibitor equivalent to 2 NRTI plus a non-nuclear reverse transcriptase inhibitor (NNRTI), as measured by the change in viral load between the entry level and the value after 4 years of treatment? 2) Should subjects experiencing a virologic relapse switch to a new regimen at a viral load of 1,000 copies/ml or after the viral load has increased to 30,000 copies/ml? In the second regimen, subjects will receive 2 new NRTI plus either an NNRTI or a protease inhibitor, whichever they had not received in the initial regimen. Stratification will be done by age (<3 years, >3 years), perinatal exposure to antiretroviral therapy, and site (American vs. European). The analysis will consist of intent-to-treat analyses with an analysis of covariance for the various factors in different arms. 256 subjects will be enrolled.

该副本是使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，这是调查员的机构。 这是对抗逆转录病毒疗法组合疗法和抗逆转录病毒抗逆转录病毒疗法的随机开放标签研究，抗逆转录病毒NATHE的儿童> 30天且<18岁。这项儿科ACTG（AIDS）研究将解决两个主要问题：1）是初始抗逆转录病毒疗法，由2种核逆转录酶抑制剂（NRTI）以及一个等于2 NRTI以及非核酸反向反向转录酶抑制剂（NNRTI）的蛋白酶抑制剂（NRTI）等于2 NRTI（NNRTI）的量化量，并通过对级别的降级进行了验证？ 2）患有病毒学继电器的受试者是否应以1,000份/mL的病毒载荷或病毒载荷后的病毒负载转换为新方案，或者在病毒载荷后增加到30,000份/ml？在第二个方案中，受试者将获得2个新的NRTI加上NNRTI或蛋白质抑制剂，无论他们在初始方案中尚未收到的蛋白质抑制剂。分层将按年龄（<3岁，> 3岁），围产期暴露于抗逆转录病毒疗法和现场（美国与欧洲）。该分析将包括意图对治疗分析，并分析不同臂中各种因素的协方差。 256名受试者将被录取。