AMBISOME VS AMPHOTERICIN B FOLLOWED BY FLUCONAZOLE IN TREATMENT OF MENINGITIS

本试验是一项III期、多中心、三组、平行组， 随机、双盲研究，比较两种剂量的Am Bisome与 青蒿素B在艾滋病急性期首次发作患者中的应用。 的 目的是评价两种药物的安全性、耐受性和有效性， AmBisome与阿替霉素B的剂量，其次是氟康唑， 艾滋病患者首次急性隐球菌性脑膜炎。 的 计划样本量为300例可评价患者。 患者将 随机接受AmBisome 3.0 mg/kg/天。 AmBisome 6.0 mg/kg/天或 诱导期为2 - 3周，给予阿替霉素B 0.7 mg/kg/天。 然后患者将接受氟康唑400 mg i.v.或p.o.日报 巩固治疗，以完成10周的方案指导治疗。

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.