ACTG A5142: A PHASE III, RANDOMIZED, OPEN-LABEL COMPARISON OF LOPINAVIR/

ACTG A5142：洛匹那韦/洛匹那韦的 III 期、随机、开放标签比较

• 批准号: 7378718
• 负责人: WILLIAM AUSTIN O'BRIEN
• 金额: $ 0.07万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378718
• 关键词: ACTG; A5142; PHASE; III; RANDOMIZED

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. Critical assessment of the role of newer treatement strategies and drugs as they become available and their role in management of HIV-1 infection is essential. ACTG A5142 is a phase III, randomized, three-arm, open label study comparing the effectiveness of an NNRTI-based regimen (efavirenz + stavudine extended release or zidovudine + lamivudine), a ritonavir-enhanced PI-based regimen (lopinavir/ritonavir + stavudine extended release or zidovudine + lamivudine) and an NRTI-sparing regimen (efavirenz + lopinavir/ritonavir) for the initial treatment of HIV infection. This study will look at the role of lopinavir/ritonavir, a ritonavir-enhanced second generation PI, and an NRTI-sparing regimen, which are not being addressed adequately in current research. The study will enroll 660 HIV-1, antiretroviral male and female subjects having a viral load equal to or greater than 2000 copies/mL. This is a 96-week study; subjects will continue on study until the last subject enrolled completes 96 weeks. There are three steps to the study. Step 1 is randomization to initial study regimens at study entry. Subjects with a toxicity to a single drug on Step 1 who substitute a single, within-class drug will register to Step 2. Subjects on Step 1 or 2 who develop virologic failure or a treatment-limiting toxicity will register to Step 3.

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。在新的治疗策略和药物面世时，对它们的作用及其在管理艾滋病毒-1感染方面的作用进行严格评估是至关重要的。ACTG A5142是一项III期随机三臂开放标签研究，比较了基于NNRTI的方案(efavirenz+stavudine缓释剂或齐多夫定+拉米夫定)、基于利托那韦的PI增强型方案(lopinavir/ritonavir+stavudine缓释剂或齐多夫定+拉米夫定)和不使用NRTI的方案(efavirenz+lopinavir/ritonavir)在初始治疗HIV感染方面的有效性。这项研究将着眼于洛比那韦/利托那韦、利托那韦增强的第二代PI和NRTI保留方案的作用，这些在目前的研究中没有得到充分的解决。这项研究将招募660名HIV-1抗逆转录病毒男性和女性受试者，他们的病毒载量等于或大于2000拷贝/毫升。这是一项为期96周的研究；受试者将继续学习，直到最后一名注册的受试者完成96周。这项研究分为三个步骤。第一步是在研究开始时随机选择初始研究方案。步骤1中对单一药物有毒性的受试者如果替代了单一的类内药物，将注册到步骤2。步骤1或步骤2中出现病毒学失败或治疗限制性毒性的受试者将注册到步骤3。