AMBISOME VS AMPHOTERICIN B FOLLOWED BY FLUCONAZOLE IN TREATMENT OF MENINGITIS

本次试验为III期，多中心，三臂，平行组， 两种剂量的Am Bisome的随机双盲研究 两性霉素B在艾滋病患者中的首次急性发作。这个 目的：评价两种药物的安全性、耐受性和有效性。 AmBisome与两性霉素B的剂量比较，然后是氟康唑 艾滋病患者首次发病的急性隐球菌性脑膜炎。这个 计划样本量为300名可评估患者。病人将会是 随机给予氨比妥3.0 mg/kg/d。氨苯磺胺6.0毫克/公斤/天或 两性霉素B 0.7 mg/kg/d，诱导期2-3周。 然后患者将接受氟康唑400 mg静脉注射。或者是邮政总局。每日AS 巩固治疗，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.