CLINICAL TRIAL: PACTG 390: ANTIRETROVIRAL REGIMENS AND TREATMENT-SWITCHING STRAT

临床试验：PACTG 390：抗逆转录病毒治疗方案和治疗转换策略

• 批准号: 7718416
• 负责人: William Borkowsky
• 金额: $ 1.27万
• 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/7718416
• 关键词: AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Address; Age; Age-Years; American; Anti-Retroviral Agents; Child; Childhood; Clinical Trials; 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 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项II/III期随机、开放标签研究，在年龄>30天和<18岁的抗逆转录病毒初治儿童中进行抗逆转录病毒联合治疗方案和治疗转换策略。 这项儿科ACTG（AIDS）研究将解决两个主要问题：1）初始抗逆转录病毒治疗（包括2种核逆转录酶抑制剂（NRTI）加一种蛋白酶抑制剂）是否等同于2种NRTI加一种非核逆转录酶抑制剂（NNRTI），通过治疗4年后病毒载量在起始水平和数值之间的变化来衡量？2)病毒学复发的受试者是否应在病毒载量为1，000拷贝/ml时或病毒载量增加至30，000拷贝/ml后转换为新方案？ 在第二种方案中，受试者将接受2种新的NRTI加一种NNRTI或一种蛋白酶抑制剂，以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和研究中心（美国vs.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。 将入组256例受试者。