AMPHOTERICIN B USED ALONE OR COMBINED WITH FLUCONAZOLE TO TREAT AIDS/MENINGITIS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a Phase II open-label, randomized study in subjects with proven or presumptive AIDS. This research study is being done to learn if it is safe or maybe even better to give the drugs amphotericin B and fluconazole together at the same time to patients with AIDS and an infection in their brain called cryptococcal meningitis. Cryptococcal meningitis is a fungal infection and is a common complication in patients with AIDS. Usually cryptococcal meningitis is treated by first giving amphotericin B alone and then fluconazole alone. This study will look at whether study subjects recover more quickly and have fewer side effects if they are given both drugs at the same time for 2 weeks followed by 8 weeks of fluconazole as compared to the standard treatment. There will be 3 arms in this study enrolling a maximum of 150 subjects to identify 120 evaluable subjects (40 per arm). The standard therapy arm will include amphotericin B 0.7 mg/kg per day for 14 days followed by fluconazole 400 mg daily for 8 weeks. The two (2) investigational treatment arms will include daily amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day or 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day or 800 mg/day respectively for an additional