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

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。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。所列机构为中心，不一定是研究者所在机构。本研究将比较HIV-1感染初始治疗的三种抑制剂（PI）保留治疗方案。治疗的目标是抑制和维持HIV-1 RNA水平< 200拷贝/ml。将在约66周内入组1125例受试者。受试者将被随机分配到以下盲法步骤1治疗组之一：A组）阿巴卡韦（ABC）/拉米夫定（3 TC）/齐多夫定（ZDV）BID +3 TC/ZDV安慰剂BID +依法韦仑（EFV）600 mgQD。B组）ABC/3 TC/ZDV BID +3 TC/ZDV安慰剂BID + EFV安慰剂QD。C组）ABC/3 TC/ZDV安慰剂BID +3 TC/ZDV BID + EFV 600 mg QD。受试者将在末例受试者入组后接受96周随访。总研究持续时间约为3年。确认病毒载量<10.00拷贝/ml的受试者可继续进行第1步或登记至第2步。第2步开放标签治疗包括2组：D组）2种核苷逆转录酶抑制剂（Nrtis）+ EFV 600 mg QD和E组）2种NRTI + BMS-232632 400 mg QD。受试者也可以参加A5097子研究-依法韦仑对HIV阳性个体的神经心理学表现、情绪和睡眠行为的影响。本研究将描述与未使用EFV的治疗相比，EFV治疗开始时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。受试者将完成问卷调查以评价该信息。子研究A5107 s是一项药理学子研究，旨在研究新型蛋白酶抑制剂BMS-2326-32。

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.