Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS

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.