RESPONSE OF HEPATITIS C VIRUS TO INTERFERON ALPHA & RIBAVARIN

丙型肝炎病毒对干扰素α的反应

• 批准号: 6264675
• 负责人: DOUGLAS DIETERICH
• 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/6264675
• 关键词: HIV infections; antiviral agents; clinical research; drug adverse effect; hepatitis C; hepatitis C virus; human subject; human therapy evaluation; immunotherapy; interferon alpha; liver function; microorganism disease chemotherapy

This is a multi-center, randomized, double-blinded, placebo-controlled, phase II/III study of the safety and anti-HCV activity of ribavarin and IFN alpha-2b as compared to IFN alpha-2b alone for the treatment of HCV disease in HIV co-infected individuals. The study has a cross-over design so that participants randomized to IFN alpha-2b monotherapy who have detectable plasma HCV-RNA at Week 12 will have ribavirin placebo replaced with ribavirin (in a blinded manner). This study is designed to observe changes in plasma HCV-RNA levels over time and sustained changes in plasma HCV-RNA in persons who are taking ribavirin with IFN alpha-2b as compared to persons taking IFN alpha-2b alone. Changes in HIV disease progression, as measured by plasma HIV-1 RNA levels, CD4+ cell count, and occurrence of AIDS defining opportunistic infections, will also be assessed. Participants' ability to tolerate potentially hepatotoxic agents, such as protease inhibitors, will also be assessed by monitoring of liver function tests (e.g. ALT).

这是一项多中心、随机、双盲、安慰剂对照、II/III期研究，旨在评估利巴韦林和IFN α-2b与IFN α-2b单独治疗HIV合并感染个体中HCV疾病的安全性和抗HCV活性。 该研究采用交叉设计，因此随机分配至IFN α-2b单药治疗组的参与者在第12周时可检测到血浆HCV-RNA，将用利巴韦林替代利巴韦林安慰剂（以盲法）。 本研究旨在观察与单独使用IFN α-2b的人相比，使用利巴韦林和IFN α-2b的人血浆HCV-RNA水平随时间的变化以及血浆HCV-RNA的持续变化。 还将评估HIV疾病进展的变化，如血浆HIV-1 RNA水平、CD 4+细胞计数和AIDS定义的机会性感染的发生率。还将通过监测肝功能检查（例如ALT）评估受试者耐受潜在肝毒性药物（如蛋白酶抑制剂）的能力。