- HIV infection documented by antibody (ELISA on two occasions or ELISA with Western
blot confirmation), p24 antigen testing, or recovery of HIV in culture.
Prior Medication:
Required:
- Minimum total dose of 15 mg/kg of amphotericin B (either alone or in combination with
flucytosine) during primary therapy. End of primary therapy within 6 weeks of start of
maintenance therapy.
- Allowed:
- Past or present antiviral therapy and prophylaxis for Pneumocystis carinii pneumonia
(PCP).
- Pfizer must be notified if the patient is receiving ganciclovir at entry. Allowed with
amphotericin B to treat or prevent side effects.
- Antipyretics.
- Hydrocortisone.
- Meperidine.
Co-existing Condition:
Patients with the following are excluded:
- Clinical evidence of acute or chronic meningitis other than cryptococcosis.
- Allergy or intolerance of imidazoles, azoles, or amphotericin B. Unable to take oral
medications reliably.
Patients with the following are excluded:
- Clinical evidence of acute or chronic meningitis other than cryptococcosis.
- Allergy or intolerance of imidazoles, azoles, or amphotericin B.
Prior Medication:
Excluded for more than 7 days after initiation of primary therapy for cryptococcosis:
- Ketoconazole.
- Fluconazole.
- Itraconazole.
- Miconazole.
- Any other systemic imidazole or azole.
- Excluded:
- Intrathecal amphotericin B.
- Coumadin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drug or approved (licensed) drugs for investigational indications.
Prior Treatment:
Excluded:
- Lymphocyte replacement.