COMPARE TWICE DAILY POTENT ANTIRETROVIRAL THERAPY

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。这项针对HIV感染者的研究将比较每天自我给药一次、每天两次和每天监督服用一次三种抗艾滋病毒药物的安全性和有效性。两种核苷逆转录酶抑制剂药物和一种复合蛋白酶抑制剂将被提供给装有电子监测设备的药丸容器中的受试者，以记录每次打开容器的时间和日期。受试者将被随机分配到三个研究小组中的一个。所有受试者每日服用恩曲他滨(FTC)和司他夫定(D4TXR)一次。A组每日服用两次卡莱特拉，B组每日服用一次卡莱特拉。C组受试者也将每天服用一次卡莱特拉，但在前6个月内接受直接监督。将有375个科目报名参加。受试者将在48周内进行最多13次访问。评估将包括实验室测试、体检、病史和用药史以及问卷调查。

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 for HIV-infected subjects will compare the safety and efficacy of self-administered once daily, twice daily, and once daily supervised dosing of three anti-HIV drugs. Two nucleoside reverse transcriptase inhibitor drugs and one combination protease inhibitor will be provided to subjects in pill containers with electronic monitoring devices to record the time and date of each opening of the container. Subjects will be randomized to one of three study arms. All subjects will take emtricitabine (FTC) and stavudine (d4T XR) once daily. Those in group A will also take Kaletra twice daily and those in group B will take Kaletra once daily. Group C subjects will also take Kaletra once daily, but under direct supervision for the first 6 months. A total of 375 subjects will be enrolled. Subjects will have up to 13 visits over 48 weeks. Evaluations will include laboratory testing, physical exams, medical and medication histories, and questionnaires.