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

HIV 初始 RX 的三种蛋白酶抑制剂保留方案 (A5095)

• 批准号: 7379064
• 负责人: JAMES K RICHARDSON
• 金额: $ 4.09万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7379064
• 关键词: THREE; PROTEASE; INHIBITOR; SPARING; REGIMENS

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.

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。本研究将比较三种保留抑制剂（PI）的治疗方案用于HIV-1感染的初始治疗。治疗的目标将是抑制和维持HIV-1 RNA水平< 200拷贝/ml。1125名受试者将在大约66周的时间内入组。受试者将被随机分配到以下盲法第1步治疗组之一：A组阿巴卡韦(ABC)/拉米夫定(3TC)/齐多夫定（ZDV） BID + 3TC/ZDV安慰剂BID +依非韦伦（EFV） 600mg QD。组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 600mg QD。在最后一名受试者入组后，这些受试者将被随访96周。总学习时间约为3年。确认病毒载量< 10,000拷贝/ml的受试者可以继续进行步骤1或注册到步骤2。开放标签治疗包括2组：D组2核苷逆转录酶抑制剂(Nrtis) + EFV 600 mg QD和E组2 Nrtis + BMS-232632 400 mg QD。受试者还可以参加A5097s的子研究——依非韦伦对hiv阳性个体的神经心理表现、情绪和睡眠行为的影响。本研究将描述与非EFV治疗相比，与EFV治疗开始相关的神经症状和体征的发生率、持续时间和认知运动影响。受试者将完成问卷来评估这些信息。亚研究A5107s是研究新型蛋白酶抑制剂BMS-2326-32的药理学亚研究。