AMBISOME VS AMPHOTERICIN B FOLLOWED BY FLUCONAZOLE IN TREATMENT OF MENINGITIS

Ambisome 对比两性霉素 B 并随后使用氟康唑治疗脑膜炎

• 批准号: 6117822
• 负责人: JOSEPH WHEAT
• 金额: $ 1.7万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 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/6117822
• 关键词: AIDS; amphotericin B; antibacterial agents; bacterial meningitis; clinical research; combination chemotherapy; dosage; drug adverse effect; drug screening /evaluation; fluconazole; human subject; human therapy evaluation

This trial is a phase III, Multicenter, three arm, parallel group, randomized, double blind study comparing two doses of Am Bisome to amphotericin B in AIDS patients witha first episode of acute. The objective is to evaluate the safety, tolerability and efficacy of two doses of AmBisome versus amphotericin B, Followed by fluconazole, for a first episode of acute cryptococcal meningitis in AIDS patients. The planned sample size is 300 evaluable patients. The patients will be randomized to receive AmBisome 3.0 mg/kg/day. AmBisome 6.0 mg/kg/day or amphotericin B 0.7 mg/kg/day for a two to three week induction period. Patients will then receive fluconazole 400 mg i.v. or p.o. daily as consolidation therapy to complete 10 weeks of protocol directed therapy.

该试验是三期，多中心，三臂，平行组，