ACTG377--ANTIRETROVIRAL REGIMENS W/ COMBOS OF PROTEASE INHIBITORS

ACTG377--蛋白酶抑制剂组合的抗逆转录病毒治疗方案

• 批准号: 6264761
• 负责人: Stuart E Starr
• 金额: $ 0.06万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 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/6264761
• 关键词: HIV infections; antiAIDS agent; clinical research; clinical trial phase I; combination chemotherapy; human immunodeficiency virus 1; human subject; human therapy evaluation; longitudinal human study; nevirapine; protease inhibitor; ritonavir; virus RNA; virus replication

ACTG 377 is a Phase I/II, randomized, open label, multi-arm study with experimental therapies added in a rolling protocol format. The primary goal of ACTG 377 is to evaluate a series of combinations of antiretroviral agents with respect to the change in plasma HIV-1 RNA copy number, safety and tolerance, and to determine which of these therapies warrants investigation in a Phase III study. This study evaluates d4T/Nevirapine/ Ritonavir vs. d4T/3TC/Nelfinavir vs. d4T/Nevirapine/Nelfinavir vs. d4T/3TC/Nevirapine/Nelfinavir with respect to their ability to induce undetectable plasma HIV-1 RNA copy number and to reduce plasma HIV-1 RNA copy number by > 2 logs at 12 weeks.

ACTG 377 是一项 I/II 期、随机、开放标签、多臂研究，以滚动方案形式添加实验疗法。 ACTG 377 的主要目标是评估一系列抗逆转录病毒药物组合对血浆 HIV-1 RNA 拷贝数变化、安全性和耐受性的影响，并确定其中哪些疗法值得在 III 期研究中进行研究。 本研究评估了 d4T/奈韦拉平/利托那韦、d4T/3TC/奈非那韦、d4T/奈韦拉平/奈非那韦、d4T/3TC/奈韦拉平/奈非那韦诱导不可检测的血浆 HIV-1 RNA 拷贝数和减少血浆的能力12 周时 HIV-1 RNA 拷贝数增加 > 2 个对数。