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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项关于联合抗逆转录病毒疗法和治疗转换策略的II/III期随机开放研究，研究对象为30天和18岁的抗逆转录病毒初生儿。这项儿科ACTG(艾滋病)研究将解决两个主要问题：1)最初的抗逆转录病毒治疗是否包括2种核逆转录酶抑制剂(NRTI)+1种相当于2 NRTI+1种非核逆转录酶抑制剂(NNRTI)的抗逆转录病毒治疗，根据治疗4年后病毒载量入门水平和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/毫升时或在病毒载量增加到30,000拷贝/毫升后切换到新的方案？在第二个方案中，受试者将接受2个新的NRTI加上一个NNRTI或一个蛋白酶抑制剂，无论他们在最初的方案中没有接受过哪一种。分层将根据年龄(&lt；3岁，&gt；3岁)、围产期是否接受抗逆转录病毒治疗以及地点(美国与欧洲)进行。该分析将包括意向治疗分析，并对不同军备中的各种因素进行协方差分析。将招收256个科目。

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.