P1034 10

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。 这项研究是一项多中心的第三阶段开放随机临床试验，将在HIV-1感染的青少年中比较两种HAART策略(I)基于PI的HAART方案和基于NNRTI的HAART方案对病毒学结果的影响，以及(Ii)治疗药物监测(TDM)和不使用TDM对病毒学结果的影响。感染艾滋病毒的青少年，无论感染途径如何，如果年龄在13至23岁之间，感染艾滋病毒的拷贝数为10,000份/毫升，并且受试者的初级保健提供者认为他们接受了抗逆转录病毒治疗，则在征得同意后，将纳入这些青少年。符合条件的受试者可能不接受抗逆转录病毒治疗，或者可能已经接受了单一联合治疗方案，包括含或不含单一PI的NRTI(洛匹那韦除外)。然而，除了怀孕期间接受ZDV单一治疗外，他们一生中可能没有接受过超过一种方案，而且他们必须是非核苷类逆转录酶抑制物(NNRTI)。 这项研究的另一个组成部分将检查队列中的治疗药物监测(TDM)。受试者将在随机化时被随机分为TDM组和非TDM组。对于含有PI的HAART方案与保留PI的方案以及TDM与不含TDM的两个随机比较，主要终点是随机后24至48周内接受指定研究治疗时的病毒学抑制率。

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. The study is a multicenter Phase III, open-label, randomized clinical trial that will compare two HAART strategies in HIV-1 infected adolescents (i) the effects of a PI-based HAART regimen versus an NNRTI-based HAART regimen on virologic outcome and (ii) the effects of therapeutic drug monitoring (TDM) versus no TDM on virologic outcome. HIV-infected adolescents, regardless of route of infection, who are 13 to 23 years of age with HIV RNA >10,000 copies/ml and for whom antiretroviral treatment is felt to be indicated by a subject's primary care provider will be enrolled after consent is obtained. Eligible subjects may be na¿ve to antiretroviral therapy, or may have received a single regimen of combination therapy, consisting of NRTIs with or without a single PI (except lopinavir). They however may not have received more than a single regimen in their lifetime with the exception of ZDV monotherapy during pregnancy, and they must be na¿ve to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class. Another component of the study will examine therapeutic drug monitoring (TDM) in the cohort. Subjects will be randomized to TDM or no TDM arm at the time of randomization. For the two randomized comparisons of PI-containing HAART regimen versus PI-sparing regimen and TDM versus no TDM, the primary endpoint is the rate of virologic suppression while on the assigned study therapy between 24 and 48 weeks after randomization.