THREE PROTEASE INHIBITOR-SPARING REGIMENS FOR INITIAL RX OF HIV (A5095)

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。这项研究将比较三种非抑制剂(PI)治疗方案，用于HIV-1感染的初始治疗。治疗的目标将是抑制和维持HIV-1RNA水平&200拷贝/毫升。将在大约66周内招募1125名受试者。受试者将被随机分到以下盲法第1步治疗组：A组：阿巴卡韦(ABC)/拉米夫定(3TC)/齐多夫定(ZDV)Bid+3TC/ZDV安慰剂Bid+Efavirenz(EFV)600 mg，qd。ARM B)ABC/3TC/ZDV BID+3TC/ZDV安慰剂BID+EFV安慰剂qd。ARM C)ABC/3TC/ZDV安慰剂Bid+3TC/ZDV Bid+EFV 600 mg，qd。在最后一门课注册后，这些科目将被跟踪96周。总的学习时间约为3年。受试者将确认病毒载量和10，00拷贝/毫升可以保留在步骤1或注册到步骤2。步骤2开放标签治疗包括2个臂：2个核苷类逆转录酶抑制剂(NRTIs)+EFV 600 mg qd和ARM E)2个NRTIs+BMS-232632 400 mg qd。受试者还可以参加A5097的子研究--Efavirenz对HIV阳性患者的神经心理表现、情绪和睡眠行为的影响。这项研究将描述与EFV治疗和非EFV治疗相比，与EFV治疗相关的神经系统症状和体征的发生率、持续时间和认知运动效应。受试者将完成问卷以评估这些信息。A5107s亚研究是研究新型蛋白水解酶抑制剂BMS-2326-32的药理学亚研究。

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. This study will compare three inhibitor (PI)-sparing treatment options for the initial treatment of HIV-1 infection. The goal of therapy will be to suppress and maintain HIV-1 RNA levels < 200 copies/ml. 1125 subjects will be enrolled over approximately 66 weeks. the subjects will be randomized to one of the following blinded Step 1 treatment arms: Arm A)Abacavir (ABC)/lamivudine (3TC)/Zidovudine (ZDV) BID + 3TC/ZDV placebo BID + Efavirenz (EFV) 600mg QD. Arm B) ABC/3TC/ZDV BID + 3TC/ZDV placebo BID + EFV placebo QD. ARM C) ABC/3TC/ZDV placebo BID + 3TC/ZDV BID + EFV 600mg QD. The subjects will be followed for 96 weeks beyond enrollment of the the last subject. The total study duration will be approximately 3 years. Subjects will confirmatory viral load < 10,00 copies/ml may either remain on step 1 or register to step 2. Step 2 Open Label Treatment includes 2 arms: Arm D) 2 nucleoside reverse-transcriptase inhibitors (Nrtis) + EFV 600 mg QD and Arm E) 2 NRTIs + BMS-232632 400 mg QD. Subjects may also participate in A5097s the substudy-Impact of Efavirenz on Neuropsychological Performance, Mood, and sleep Behavior in HIV-Positive Individuals. This study will describe the incidence, duration, and cognitive motor effects of neurologic symptoms and signs associated with initiation of EFV therapy compared to therapy without EFV. Subjects will complete questionnaires to evaluate this information. Substudy A5107s is a pharmacology substudy to investigate the new protease inhibitor BMS-2326-32.