PACTG 1021:

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。在联合药物治疗方案中使用不同的抗逆转录病毒药物是目前管理艾滋病毒感染者的最新技术。这些方案结合了不同的抗病毒靶点，有望提高疗效，降低毒性，并延缓个别药物的耐药性发展。药物联合治疗产生的预期协同效应是本研究评估的主要目标之一。将在PACTG P1021中使用的FTC每日一次的儿科剂量方案得到了在18岁以下艾滋病毒感染或暴露的儿科受试者中进行的I期单次剂量试验的数据支持。每日一次给药方法的选择是基于最近在法国发表的ANRS临床试验的数据，这一点以前曾讨论过(2，4，5，6)。很好地认识到，难以确保遵守目前需要每天多次剂量的方案，这是有效抗逆转录病毒治疗的主要障碍。每天一次的养生法对儿科受试者和他们的照顾者都有好处。

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 use of different anitretrovial agents in combination drug therapy regimens is the current state of the art for mangement of HIV-infected subjects. These regimens combine different antiviral targets, which are expected to increase the efficacy, decrease the toxicity and delay the development of resistance of the individual drugs. The anticipated synergistic effect produced by drug combination therapy is one of the primary objectives for evaluation in this study. The once daily pediatric dose regimen of FTC that will be used in PACTG P1021 is supported by data from a Phase I single-dose trial in HIV-infected or exposed pediatric subjects less than 18 years of age. The selection of a once daily dosing approach was based on the recently published data for the ANRS clinical trial in France, which was previously discussed (2,4,5,6). The difficulty in assuring adherence with current regimens requiring multiple daily doses is well recognized as a major barrier to effective antiretroviral therapy. A once daily regimen offers both advantage for pediatric subjects and their caregivers.