LOPINAVIR/RITONAVIR PLUS EFAVIRENZ VERSUS LOPINAVIR/RITONAVIR PLUS STAVUDINE

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。A5142将评估三种不同的抗艾滋病毒药物方案作为艾滋病毒感染一线治疗的安全性和有效性。还将评估这些方案的效果。这些药物方案是：洛匹那韦/利托那韦和伊法韦仑，洛匹那韦/利托那韦，司他夫定(或齐多夫定)和拉米夫定。如果一种药物方案未能降低病毒载量，或者如果病毒对治疗产生抗药性，受试者将被切换到不同的治疗方法。666名受试者将被随机分配到三个治疗组中的一个。受试者将被跟踪观察96到138周，具体取决于他们的注册时间；学习访问将每四周进行一次，直到第32周，然后每8周进行一次。评估将包括病史和用药史、有针对性的体检、拟人化测量、实验室评估和双能X射线吸收扫描(DEXA)。

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. A5142 will evaluate the safety and efficacy of three different anti-HIV drug regimens as first-line treatment for HIV infection. The effects of the regimens will also be assessed. The drug regimens are: lopinavir/ritonavir and efavirenz, lopinavir/ritonavir, stavudine (or zidovudine) and lamivudine. If a drug regimen fails to lower the viral load or if the virus becomes resistant to therapy, subjects will be switched to a different therapy. Six hundred sixty-six subjects will be randomized into one of the three treatment arms. Subjects will be followed for between 96 to 138 weeks, depending on when they enroll; study visits will be every four weeks up to week 32 and then every eight weeks thereafter. Assessments will include medical and medication histories, targeted physical exams, anthropomorphic measurements, laboratory evaluations, and a Dual energy x-ray absorptiometry scan (DEXA).