INTENSIFICATION OF HIV-SPECIFIC CD4 AND CD8 ACTIVITY BY CYCLING HIGHLY ACTIVE

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。PACTG P1015是由美国国家过敏和传染病研究所(NIAID)和美国国立卫生研究院(NIH)国家儿童健康与人类发育研究所(NICHD)支持的儿科艾滋病临床试验小组(PACTG)的一项多中心治疗试验。这是一项概念验证研究，对2至21岁受试者进行了HAART开关循环和连续HAART的比较，以确定(1)最初短暂的HAART暂停间隔，然后是越来越长的HAART暂停间隔是否会导致HIV特异性CD8和/或CD4活性增加；(2)这种增加是否会导致病毒血症的长期抑制，并随后停止HAART；(3)HIV特异性免疫的刺激是否会降低HIV前病毒载量；(4)增加HAART假期的持续时间是否会导致耐药病毒的出现，或者如果药物敏感病毒持续存在。日期为2003年12月5日的3.0版增加了连续第四个可检测周期，如果RNA为？50拷贝/毫升，以解决罗氏RNA检测变异性的问题。

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. PACTG P1015 is a multi-center, treatment trial of the Pediatric AIDS Clinical Trials Group (PACTG) supported by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Child Health and Human Development (NICHD), NIH. This is a proof of concept study comparing cycling on and off of HAART with continuous HAART in subjects aged between 2 and 21 years to determine (1) if initially brief intervals of HAART suspension followed by increasingly prolonged intervals of HAART suspension result in increased HIV-specific CD8 and/or CD4 activity; (2) whether such an increase will result in prolonged suppression of viremia with subsequent suspension of HAART; (3) whether the stimulation of HIV-specific immunity reduces HIV proviral load and (4) whether cycles of HAART holidays of increasing duration result in the emergence of drug resistant virus or if drug sensitive virus persists. Version 3.0 dated 12/05/2003 added a fourth consecutive detectable cycle if the RNA is ? 50 copies/mL to address the Roche RNA assay variability concern.