AMPRENAVIR, ABACAVIR, EFAVIRENZ, ADEFOVIR DIPIVOXIL VS AMPRENAVIR ALO

安普那韦、阿巴卡韦、依非韦伦、阿德福韦酯 VS 安普那韦 ALO

• 批准号: 6265140
• 负责人: MD MICHAEL FRANK
• 金额: $ 0.04万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6265140
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; clinical research; combination chemotherapy; drug screening /evaluation; human subject; human therapy evaluation; protease inhibitor; reverse transcriptase inhibitors

This will be a Phase II, randomized, partially placebo-controlled, 4-arm trial comparing amprenavir (APV) in a single-PI regimen versus APV in combination with saquinavir (SQVsgc), indinavir (IDV) or nelfinavir (NFV) in HIV-infected subjects currently failing IDV, RTV, SQV or NFV, as reflected by a plasma HIV-1 RNA concentration of >1000 copies/ml. Eligible subjects must be currently failing IDV, NFV, SQV, or RTV as part of a single or dual PI regimen (as evidenced by two consecutive plasma HIV RNA levels > 1000 copies/ml) after at least 16 cumulative weeks of protease inhibitor exposure. Subjects may have prior exposure to up to three protease inhibitors (IDV, RTV, SQV or NFV) including the currently failing regimen. For the purposes of this study, "exposure" to a protease inhibitor is considered >7 cumulative days of treatment. No prior exposure to efavirenz (EFV), amprenavir (APV), abacavir (ABC) or adefovir dipivoxil (ADV) is allowed. Subjects with nevirapine or delavirdine exposure will be permitted to enroll but will be limited to 1.3 of the study population. Prior exposure to NRTIs is allowed. 460 subjects to be enrolled over a 6 month period. Subjects will be stratified for prior PI and NNRTI exposure. All subjects will receive amprenavir (APV), abacavir (ABC), efavirenz (EFV) and adefovir dipivoxil (ADV). Subjects will be selectively randomized to one of four treatment arms as described below. All subjects will have an equal or greater chance of being randomized to a dual-PI arm than the single-PI arm.

这将是一项II期、随机、部分安慰剂对照、四组试验，比较单pi方案中的amprenavir （APV）与APV联合沙奎那韦（SQVsgc）、因地那韦（IDV）或奈非那韦（NFV）在目前IDV、RTV、SQV或NFV失败的hiv感染受试者中的应用，反映在血浆HIV-1 RNA浓度为1000拷贝/ml。符合条件的受试者必须在至少16周的蛋白酶抑制剂暴露后，作为单或双PI方案的一部分，目前IDV， NFV， SQV或RTV失败（通过连续两次血浆HIV RNA水平bb1000拷贝/ml证明）。受试者之前可能暴露于多达三种蛋白酶抑制剂（IDV， RTV， SQV或NFV），包括目前失败的方案。为了本研究的目的，“暴露”于蛋白酶抑制剂被认为是70天的累积治疗。先前不允许暴露于依非韦伦（EFV）、安普雷那韦（APV）、阿巴卡韦（ABC）或阿德福韦酯（ADV）。奈韦拉平或德拉韦定暴露的受试者将被允许入组，但限于研究人群的1.3%。事先接触nrti是允许的。在6个月的时间里，将招收460名受试者。受试者将根据先前的PI和NNRTI暴露情况进行分层。所有受试者将接受安非那韦（APV）、阿巴卡韦（ABC）、依非韦伦（EFV）和阿德福韦酯（ADV）治疗。受试者将被选择性地随机分配到如下所述的四个治疗组之一。所有受试者将有相同或更大的机会被随机分配到双pi组，而不是单pi组。