To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal
meningitis in AIDS patients. Both newly diagnosed and relapsed patients are eligible.
Inclusion Criteria
Concurrent Medication:
Allowed:
- Antiviral therapy such as zidovudine.
- Prophylaxis for Pneumocystis carinii pneumonia.
- Aerosolized 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.
- 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:
- Antiviral therapy such as zidovudine.
- Prophylaxis for Pneumocystis carinii pneumonia.
- Aerosolized 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 defined by specified lab values.
- Patients who are unable to take oral medication.
- Unlikely to survive more than 2 weeks.
- Renal impairment.
Concurrent Medication:
Excluded:
- Coumarin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications
other than aerosolized pentamidine.
- Excluded within 4 weeks of study entry:
- Greater than 1 mg/kg/wk amphotericin B.
- Any exceptions to these prohibitions of concomitant medications must be approved by
Pfizer Central Research.
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 or azoles.
- Moderate or severe liver disease defined by specified lab values.
- Patients who are unable to take oral medication.
- Life expectancy of < 2 weeks.
- Any condition that may impair absorption of oral medication.
Prior Medication:
Excluded:
- Coumarin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications
other than aerosolized pentamidine.
- Excluded within 4 weeks of study entry:
- Greater than 1 mg/kg/wk amphotericin B.
Prior Treatment:
Excluded:
- Lymphocyte replacement.
