AMPRENAVIR, ABACAVIR, EFAVIRENZ, ADEFOVIR DIPIVOXIL VS AMPRENAVIR ALO

这将是一项II期、随机、部分安慰剂对照、4组试验，在目前IDV、RTV、SQV或NFV失败的HIV感染受试者中比较单PI方案中的安普那韦（APV）与APV联合沙奎那韦（SQVsgc）、茚地那韦（IDV）或奈非那韦（NFV），如血浆HIV-1 RNA浓度>1000拷贝/ml所反映的。合格的受试者必须在至少16周累积蛋白酶抑制剂暴露后，作为单一或双重PI方案的一部分，目前IDV、NFV、SQV或RTV失败（如连续两次血浆HIV RNA水平> 1000拷贝/ml所证明）。 受试者可能既往暴露于最多3种蛋白酶抑制剂（IDV、RTV、SQV或NFV），包括当前失败的方案。 出于本研究的目的，“暴露于”蛋白酶抑制剂被认为是>7个累积治疗日。 不允许既往暴露于依法韦仑（EFV）、安普那韦（APV）、阿巴卡韦（ABC）或阿德福韦酯（ADV）。 允许入组奈韦拉平或地拉韦啶暴露的受试者，但限于研究人群的1.3例。允许之前暴露于NRTI。 将在6个月期间入组460例受试者。 将根据既往PI和NNRTI暴露对受试者进行分层。所有受试者将接受安普那韦（APV）、阿巴卡韦（ABC）、依法韦仑（EFV）和阿德福韦酯（ADV）。 受试者将选择性随机分配至下述四个治疗组之一。 所有受试者被随机分配至双PI组的机会等于或大于单PI组。

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.