To evaluate the safety and effectiveness of fluconazole as an intravenous dose as initial
treatment for acute cryptococcal meningitis followed by oral therapy in AIDS and non-AIDS
patients. Both newly diagnosed and relapsed patients are eligible. The effectiveness of
maintenance fluconazole therapy in sustaining a clinical cure in AIDS patients will also be
evaluated.
Inclusion Criteria
Concurrent Medication:
Allowed:
- Antivirals 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.
- Patient's treatment status must be one of the following:
- No prior systemic antifungal therapy for cryptococcosis.
- Relapse after prior therapy. The success of prior therapy must have been documented by
negative 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
the study.
Prior Medication:
Allowed:
- Antivirals such as zidovudine (AZT). 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.
- A history of allergy to or intolerance of imidazoles or azoles.
- Moderate or severe liver disease defined by specified lab values.
- Life expectancy of < 2 weeks.
Concurrent Medication:
Excluded:
- Coumarin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications
except aerosolized pentamidine.
Concurrent Treatment:
Excluded:
- Lymphocyte replacement.
Patients with the following are excluded:
- Evidence of acute or chronic meningitis based upon any etiology other than
cryptococcosis.
- A history of allergy to or intolerance of imidazoles or azoles.
- Moderate or severe liver disease defined by specified lab values.
- Life expectancy of < 2 weeks.
Prior Medication:
Excluded:
- Coumarin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications
except aerosolized pentamidine.
Prior Treatment:
Excluded:
- Lymphocyte replacement.
Summitt Med Ctr / San Francisco Gen Hosp, Oakland, California 94609, United States
Cook County Hosp, Chicago, Illinois 60612, United States
Cornell Univ Med Ctr, New York, New York 10021, United States
SUNY / Health Sciences Ctr at Brooklyn, Brooklyn, New York 11203, United States
Buckley Braffman Stern Med Associates, Philadelphia, Pennsylvania 19107, United States
