MKC 442--TRIPLE DRUG COMBINATION IN PATIENTS W/ HIV

MKC 442——艾滋病毒患者的三联药物

• 批准号: 6264678
• 负责人: Martin H Markowitz
• 金额: $ 4.54万
• 依托单位: ROCKEFELLER UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6264678
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; clinical research; combination chemotherapy; human subject; human therapy evaluation; protease inhibitor; reverse transcriptase inhibitors

Protocol title: An Open Label Study of MKC-422 in at Least Triple Drug Combination in patients Previously Treated with Nucleoside Reverse Transcriptase and Protease Inhibitors and Who are Naive to Non-Nucleoside Reverse Transcriptase Inhibitors Primary objectives: 1. To determine the proportion of patients whose plasma HIV-1 RNA level remains below the limit of quantification of the Roche Apmlicor assay (400 copies/ml) at each time point and at 24 weeks. 2. To determine the short term safety and tolerability of MKC-442 in combination with other antiretrovirals. 3. To determine the time to virologic failure.

方案标题：在先前接受核苷类逆转录酶和蛋白酶抑制剂治疗且未接受非核苷类逆转录酶抑制剂治疗的患者中，MKC-422至少三联用药的开放标签研究。在每个时间点和24周，确定血浆HIV-1 RNA水平低于罗氏Apmlicor测定定量限（400拷贝/ml）的患者比例。2. 确定MKC-442与其他抗逆转录病毒药物联合使用的短期安全性和耐受性。3. 确定病毒学失败的时间。