COMPARE TWICE DAILY POTENT ANTIRETROVIRAL THERAPY

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。这项针对艾滋病毒感染者的研究将比较每日一次、每日两次和每日一次监督剂量的三种抗艾滋病毒药物的安全性和有效性。将两种核苷类逆转录酶抑制剂药物和一种联合蛋白酶抑制剂药物放在装有电子监控装置的药丸容器中提供给受试者，记录每次打开容器的时间和日期。受试者将被随机分为三个研究组。所有受试者每日服用恩曲他滨（FTC）和司他夫定（d4T XR）一次。A组每天服用两次Kaletra， B组每天服用一次Kaletra。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。共有375名受试者将被纳入研究。受试者将在48周内进行多达13次访问。评估将包括实验室测试、体检、医疗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.