STUDY OF COMBINATION ANTIRETROVIRAL REGIMENS AND TX-SWITCHING IN HIV+ CHILDREN

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。这是一项国际性的多中心II/III期随机开放标签因子(2x2)试验。这项研究将纳入256名感染艾滋病毒-1(AIDS)的儿童，年龄大于30天但不到18岁，他们是抗逆转录病毒幼稚或出生后连续几天接受抗逆转录病毒药物治疗的时间少于56天，以防止母婴传播，和/或不超过两剂奈韦拉平。大约50%的孩子将来自PACTG网站，50%来自Penta网站。具体目的是比较两种NRTI加一种蛋白水解酶抑制剂(PI)和两种NRTI加一种非核苷类逆转录酶抑制剂(NNRTI)作为初始治疗的组合，如果失败，随后进行二线治疗，以比较它们对长期病毒学终点的影响，并比较从一线治疗切换到二线治疗的两种不同的病毒载量标准。在最后一位患者入选后，儿童将被跟踪至少四年(208周)。

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 an international, multicenter Phase II/III, randomized, open label, and factorial (2x2) trial. The study will enroll 256 HIV-1 (AIDS) infected children, greater than 30 days and less than 18 years of age, who are antiretroviral naive or who have received less than 56 days of antiretroviral drugs used on consecutive days after birth to prevent mother-to-infant transmission, and/or no more than two doses of nevirapine. Approximately 50% of the children will be from PACTG sites and 50% from PENTA sites. The specific aims are to compare the combination of 2 NRTIs plus a protease inhibitor (PI) versus 2 NRTIs plus a non-nucleoside reverse transcriptase inhibitor (NNRTI) as initial therapy, followed by second-line therapy if failure occurs, in terms of their effects on a long-term virologic endpoint and to compare two different viral load criteria for switching from first-line to second-line therapy. Children will be followed for a minimum of four years (208 weeks) after enrollment of the last patient.