COMPARE TWICE DAILY POTENT ANTIRETROVIRAL THERAPY

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 HIV感染受试者的研究将比较三种抗HIV药物每日一次、每日两次和每日一次自我给药的安全性和有效性。 将向受试者提供两种核苷逆转录酶抑制剂药物和一种复合蛋白酶抑制剂，装在药丸容器中，并配有电子监测装置，以记录每次打开容器的时间和日期。 受试者将被随机分配至三个研究组之一。 所有受试者将接受恩曲他滨（FTC）和司他夫定（d4 T XR）每日一次。 A组患者也将每天服用Kaletra两次，B组患者将每天服用Kaletra一次。 C组受试者也将每天服用一次Kaletra，但前6个月在直接监督下服用。 共将入组375例受试者。 受试者将在48周内接受最多13次访视。 评估将包括实验室检查、体格检查、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.