Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

Inclusion Criteria Concurrent Medication: Allowed: * Immunosuppressant therapy. * Antiviral such as zidovudine. * Radiation therapy for mucocutaneous Kaposi's sarcoma. * Prophylaxis for Pneumocystis carinii pneumonia (PCP) including aerosol pentamidine. Concurrent Treatment: Allowed: * Radiation therapy for mucocutaneous Kaposi's sarcoma. Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian. * No prior systemic antifungal therapy for cryptococcosis. * Relapse after prior therapy. * Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study. Prior Medication: Allowed: * Immunosuppressant therapy. * Antivirals such as zidovudine (AZT). * Prophylaxis for Pneumocystis carinii pneumonia (PCP) including aerosol pentamidine. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: * Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. * History of allergy to or intolerance of imidazoles, azoles, or amphotericin B. * Moderate or severe liver disease. * Comatose. * Unlikely to survive more than 2 weeks. * Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research. Concurrent Medication: Excluded: * Coumadin-type anticoagulants. * Oral hypoglycemics. * Barbiturates. * Phenytoin. * Immunostimulants. * Investigational drugs or approved (licensed) drugs for investigational indications. * Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research. * Excluded within 4 weeks of study entry: * Received more than 1 mg/kg/wk amphotericin B. Concurrent Treatment: Excluded: * Lymphocyte replacement. Patients with the following are excluded: * Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. * History of allergy to or intolerance of imidazoles, azoles, or amphotericin B. * Moderate or severe liver disease. * Comatose. * Unlikely to survive more than 2 weeks. Prior Medication: Excluded: * Coumadin-type anticoagulants. * Oral hypoglycemics. * Barbiturates. * Phenytoin. * Immunostimulants. * Investigational drugs or approved (licensed) drugs for investigational indications. * Excluded within 4 weeks of study entry: * More than 1 mg/kg/wk amphotericin B. Prior Treatment: Excluded: * Lymphocyte replacement.