Comparison of Fluconazole (UK-49,858) and Amphotericin B for Maintenance Treatment of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome

Inclusion Criteria

Inclusion Criteria

- 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.

Exclusion Criteria

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.