Open, Non-Comparative Study of Fluconazole in Patients With Coccidioidal Meningitis

Inclusion Criteria

• •Concurrent Medication:
• •Allowed:
• •Immunosuppressive therapy including corticosteroids and/or cytotoxic agents.
• •Antiviral therapy (e.g., zidovudine (AZT)).
• •Prophylaxis for Pneumocystis carinii pneumonia (PCP).
• •Any exceptions to use of concomitant medications must be approved by Pfizer Central Research prior to study entry.
• •Concurrent Treatment:
• •Allowed:
• •Radiation therapy for mucocutaneous Kaposi's sarcoma.
• •Patients must:
• •Be clinically judged to be in need of treatment for coccidioidal meningitis.
• •Have \> 1 week life expectancy.
• •Allowed:
• •Immunocompromised patients.
• •Patients with renal disease will have the dose of fluconazole adjusted and serum levels may be monitored.
• •Prior Medication:
• •Allowed:
• •Amphotericin B.
• •Ketoconazole.
• •Miconazole.
• •Immediately life-threatening coccidioidomycosis defined as infection of such a degree of clinical severity that the patient would be expected to die within 1 week, if untreated, based on clinical judgment.
• •Experienced a prior allergic reaction or major side effect from an imidazole or triazole compound.
• •Concurrent Medication:
• •Excluded:
• •Barbiturates.
• •Phenytoin.
• •Oral hypoglycemics.
• •Coumadin type anticoagulants.
• •Other systemic or intrathecal antifungal therapy.
• •Other experimental agents with exceptions noted in concomitant medications section.
• •Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research prior to study entry.
• •Patients with the following are excluded:
• •Are responding or are improving on current antifungal therapy with another agent.
• •Immediately life-threatening coccidioidomycosis defined as infection of such a degree of clinical severity that the patient would be expected to die within 1 week, if untreated, based on clinical judgment.
• •Experienced a prior allergic reaction or major side effect from an imidazole or triazole compound.