Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in AIDS patients. Both newly diagnosed and relapsed patients are eligible.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Fluconazole

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Antiviral therapy such as zidovudine.

• Prophylaxis for Pneumocystis carinii pneumonia.

• Aerosolized pentamidine.

Concurrent Treatment:

Allowed:

• Radiation therapy for mucocutaneous Kaposi's sarcoma.

Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.

• No prior systemic antifungal therapy for cryptococcosis.

• Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study.

Prior Medication:

Allowed:

• Antiviral therapy such as zidovudine.

• Prophylaxis for Pneumocystis carinii pneumonia.

• Aerosolized pentamidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

• Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.

• History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.

• Moderate or severe liver disease defined by specified lab values.

• Patients who are unable to take oral medication.

• Unlikely to survive more than 2 weeks.

• Renal impairment.

Concurrent Medication:

Excluded:

• Coumarin-type anticoagulants.

• Oral hypoglycemics.

• Barbiturates.

• Phenytoin.

• Immunostimulants.

• Investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine.

• Excluded within 4 weeks of study entry:

• Greater than 1 mg/kg/wk amphotericin B.

• Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.

Concurrent Treatment:

Excluded:

• Lymphocyte replacement.

Patients with the following are excluded:

• Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.

• History of allergy to or intolerance of imidazoles or azoles.

• Moderate or severe liver disease defined by specified lab values.

• Patients who are unable to take oral medication.

• Life expectancy of < 2 weeks.

• Any condition that may impair absorption of oral medication.

Prior Medication:

Excluded:

• Coumarin-type anticoagulants.

• Oral hypoglycemics.

• Barbiturates.

• Phenytoin.

• Immunostimulants.

• Investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine.

• Excluded within 4 weeks of study entry:

• Greater than 1 mg/kg/wk amphotericin B.

Prior Treatment:

Excluded:

• Lymphocyte replacement.