ACTG 333--HARD CAPSULE SAQUINAVIR VS SOFT GELATIN SAQUINAVIR VS INDINAVIR

ACTG 333--硬胶囊沙奎那韦VS软明胶沙奎那韦VS印地那韦

• 批准号: 6282250
• 负责人: Juan J. L. Lertora
• 金额: $ 1.97万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 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 1999-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6282250
• 关键词: AIDS therapy; HIV infections; antiAIDS agent; clinical research; dosage forms; drug screening /evaluation; human subject; human therapy evaluation; protease inhibitor

This study is a 24 week randomized 3 arm multi-center open label trial in Saquinavir (hard capsule) experienced patients. These HIV infected patients will be randomized to receive either a continuation of the hard capsule or arm 2- the new soft gelatin capsule of saquinavir which will replace the SQVhc in their drug regimen or arm 3- indinavir which will replace the Saquinavir hard capsule in their drug regimen. Subjects will continue on their same non-protease anti-HIV drugs, if on any therapy. At 8 weeks, subjects receiving SQVhc will be switched to open label Indinavir for weeks 8-24. Subjects receiving Saquinavir soft gel capsule and subjects receiving Indinavir will continue on their randomized therapy for 24 weeks unless they have no virologic response to their new therapy. Viral RNA levels will be obtained pre, during and post study enrollment.

本研究是一项为期24周的随机化3组多中心开放标签试验 沙奎那韦（硬胶囊）经验丰富的患者。 这些艾滋病毒感染者 患者将被随机分配接受持续的硬 胶囊或臂2-沙奎那韦的新的软明胶胶囊， 在他们的药物方案中取代SQVhc或组3-茚地那韦， 取代沙奎那韦硬胶囊 受试者将 继续使用相同的非蛋白酶抗HIV药物，如果正在接受任何治疗。 第8周时，接受SQVhc的受试者将转为开放标签治疗 茚地那韦8-24周。 接受沙奎那韦软胶囊的受试者 接受茚地那韦治疗的受试者将继续接受随机分组 治疗24周，除非他们对新的病毒学应答没有反应。 疗法 将在研究前、研究期间和研究后获得病毒RNA水平 招生