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。子项目和 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。 这是一项 II/III 期随机、开放标签研究，针对年龄大于 30 天且小于 18 岁的未接受过抗逆转录病毒治疗的儿童进行联合抗逆转录病毒治疗方案和治疗转换策略。 这项儿科 ACTG（艾滋病）研究将解决两个主要问题：1）初始抗逆转录病毒治疗由 2 种核逆转录酶抑制剂（NRTI）加一种蛋白酶抑制剂组成，是否相当于 2 种 NRTI 加一种非核逆转录酶抑制剂（NNRTI）（通过病毒载量在入门水平和治疗 4 年后的值之间的变化来衡量）？ 2) 经历病毒学复发的受试者是否应该在病毒载量为 1,000 拷贝/ml 时或在病毒载量增加至 30,000 拷贝/ml 后改用新的治疗方案？ 在第二个方案中，受试者将接受 2 种新的 NRTI 加上 NNRTI 或蛋白酶抑制剂，以他们在初始方案中未接受的为准。 将根据年龄（<3 岁、>3 岁）、围产期抗逆转录病毒治疗暴露情况和地点（美国与欧洲）进行分层。 该分析将包括意向治疗分析和不同组中各种因素的协方差分析。 将招收 256 名受试者。