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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项国际性、多中心II/III期、随机、开放标签和析因（2x2）试验。该研究将招募256名感染HIV-1（艾滋病）的儿童，年龄大于30天，小于18岁，未接受抗逆转录病毒治疗或在出生后连续几天接受少于56天的抗逆转录病毒药物治疗以防止母婴传播，和/或不超过两剂奈韦拉平。大约50%的孩子来自PACTG站点，50%来自PENTA站点。具体目的是比较2种nrti加蛋白酶抑制剂（PI）与2种nrti加非核苷逆转录酶抑制剂（NNRTI）作为初始治疗的组合，如果发生失败，随后进行二线治疗，就其对长期病毒学终点的影响而言，并比较从一线转向二线治疗的两种不同病毒载量标准。在最后一名患者入组后，儿童将被随访至少4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.