Concurrent Medication:
Allowed:
- Antivirals such as zidovudine.
- Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia
(PCP).
- Pfizer must be notified if the patient is receiving ganciclovir (DHPG) at entry.
Concurrent Treatment:
Allowed:
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
Patients must be oriented to person, place, and time, and able to give written informed
consent.
- Patients must have had an acute episode of cryptococcal meningitis that was documented
by recovery and identification of Cryptococcus neoformans from lumbar cerebrospinal
fluid (CSF) culture within 6 months prior to entry.
- Minimum total dose of 15 mg/kg of amphotericin B must have been given (either alone or
in combination with flucytosine) during primary therapy.
- Patients need not be receiving amphotericin B at the time of randomization but must
begin study maintenance therapy within 6 weeks of completion of primary amphotericin B
therapy. Patients may receive maintenance amphotericin B during the period between
completion of primary therapy and study entry.
Prior Medication:
Allowed:
- Antivirals such as zidovudine (AZT).
- Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia
(PCP).
Co-existing Condition:
Patients with the following are excluded:
- Clinical evidence of acute or chronic meningitis based upon any etiology other than
cryptococcosis.
- History of allergy or intolerance of imidazoles, azoles, or amphotericin B.
- Moderate or severe liver disease.
Concurrent Medication:
Excluded:
- Ketoconazole.
- Fluconazole.
- Itraconazole.
- Miconazole.
- Any systemic imidazole or azole for more than 7 days after initiation of primary
therapy for cryptococcosis.
- Intrathecal amphotericin B.
- Coumarin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications.
Concurrent Treatment:
Excluded:
- Lymphocyte replacement.
Patients with the following are excluded:
- Clinical evidence of acute or chronic meningitis based upon any etiology other than
cryptococcosis.
- History of allergy or intolerance of imidazoles, azoles, or amphotericin B.
- Moderate or severe liver disease.
- Inability to take oral medications reliably.
Prior Medication:
Excluded:
- Ketoconazole.
- Fluconazole.
- Itraconazole.
- Miconazole.
- Any systemic imidazole or azole for more than 7 days after initiation of primary
therapy for cryptococcosis.
- Intrathecal amphotericin B.
- Coumarin-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.
Prior Treatment:
Excluded:
- Lymphocyte replacement.