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.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，不一定是研究者的机构。对新治疗策略和药物的作用及其在 HIV-1 感染管理中的作用进行批判性评估至关重要。 ACTG A5142 是一项 III 期、随机、三组、开放标签研究，比较基于 NNRTI 的方案（依非韦伦 + 司他夫定缓释或齐多夫定 + 拉米夫定）、基于利托那韦增强 PI 的方案（洛匹那韦/利托那韦 +司他夫定缓释或齐多夫定 + 拉米夫定）和 NRTI 保留方案（依非韦伦 +洛匹那韦/利托那韦）用于艾滋病毒感染的初始治疗。 本研究将探讨洛匹那韦/利托那韦、利托那韦增强型第二代 PI 和 NRTI 保留方案的作用，目前的研究尚未充分解决这些问题。 该研究将招募 660 名 HIV-1 抗逆转录病毒男性和女性受试者，其病毒载量等于或大于 2000 拷贝/mL。这是一项为期 96 周的研究；受试者将继续研究，直到最后一名受试者完成 96 周。 研究分为三个步骤。第 1 步是在研究开始时随机分配初始研究方案。在步骤 1 中对单一药物产生毒性并替代单一类内药物的受试者将注册至步骤 2。在步骤 1 或 2 中出现病毒学失败或治疗限制性毒性的受试者将注册至步骤 3。