AMBISOME VS AMPHOTERICIN B FOLLOWED BY FLUCONAZOLE IN TREATMENT OF MENINGITIS

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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.