SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy

Inclusion Criteria

Concurrent Medication:

Allowed:

• Currently approved antiviral therapy.
• Maintenance therapy for cytomegalovirus retinitis or toxoplasmosis.
• Rifampin.
• Isoniazid.
• Dilantin or barbiturates if investigator agrees to rigorously monitor anticonvulsant drug levels.
• Coumarin-type anticoagulants if investigator agrees to rigorously monitor prothrombin time.
• Prophylactic treatment for Pneumocystis carinii pneumonia (PCP).

Concurrent Treatment:

Allowed:

• Local radiotherapy for mucocutaneous Kaposi's sarcoma.

Prior Medication:

Allowed:

• Amphotericin B, up to 1 mg/kg, during the previous 7 days.

Patients must be HIV positive by 2 methodologies and have either primary cryptococcal meningitis with no prior anti-cryptococcal therapy or relapsed disease after prior therapy.

• Prior therapy for cryptococcal meningitis is limited to approved drugs.
• Written informed consent either from patient or patient's parent or legal guardian is required.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• History of hypersensitivity to imidazole or azole compounds.
• Central nervous system disease.
• Acute opportunistic infection.
• Underlying conditions that in the opinion of the investigator could preclude assessment of response.

Concurrent Medication:

Excluded:

• Systemic antifungal drugs other than study drug.
• Any investigational drug other than treatment IND drugs.
• Oral hypoglycemic agents.
• Oral contraceptives.
• Cytotoxic chemotherapy.

Patients with the following are excluded:

• Unable to take oral medications.
• Concurrent central nervous system disease which in opinion of investigator would interfere with assessment of response.
• Concurrent acute opportunistic infection requiring therapy (patients who develop an acute opportunistic infection after initiation of study medication may remain on study medication).

Prior Medication:

Excluded within 7 days of study entry:

• Amphotericin B, > 1 mg/kg.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety