AMBISOME VS AMPHOTERICIN B AND FLUCONAZOLE IN CRYPTOCOCCAL MENINGITIS IN AIDS

Ambisome 对比两性霉素 B 和氟康唑治疗艾滋病隐球菌性脑膜炎

• 批准号: 6121097
• 负责人: PHILIP C JOHNSON
• 金额: $ 1.51万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 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/6121097
• 关键词: AIDS; AIDS therapy; Cryptococcus; amphotericin B; bacterial meningitis; clinical research; combination chemotherapy; drug screening /evaluation; fluconazole; human subject; human therapy evaluation; microorganism disease chemotherapy; opportunistic infections

This is a Phase III randomized, double-blind, multicenter study designed to evaluate the safety, tolerability and efficacy of two doses of AmBisome (Lipo-somal amphotericin B) versus amphotericin B, followed by fluconazole, for a first episode of acute cryptococcal meningitis in patients with AIDS. The patient will receive AmBisome or amphotericin B IV for 2 weeks, followed by eight weeks of fluconazole. The primary efficacy outcome is the incidence rate of the therapeutic success assessed in the evaluable subgroup. This study was recently completed and is being analyzed.

这是一项 III 期随机、双盲、多中心研究，旨在评估两种剂量的 AmBisome（脂质体两性霉素 B）与两性霉素 B（随后使用氟康唑）治疗艾滋病患者首次发作的急性隐球菌性脑膜炎的安全性、耐受性和有效性。患者将接受 AmBisome 或两性霉素 B IV 治疗 2 周，然后接受 8 周的氟康唑治疗。 主要疗效结果是可评估亚组中评估的治疗成功的发生率。 这项研究最近完成并正在分析中。