To evaluate the safety and effectiveness of fluconazole as an intravenous dose as initial treatment for acute cryptococcal meningitis followed by oral therapy in AIDS and non-AIDS patients. Lack of satisfactory response will allow increase of dose. Both newly diagnosed and relapsed patients are eligible.

Condition	Treatment or Intervention
Meningitis, Cryptococcal HIV Infections	Drug: Fluconazole

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

• Antivirals such as zidovudine (AZT).
• Prophylaxis for Pneumocystis carinii pneumonia (including 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.

• Patient's treatment status must be one of the following:
• No prior systemic antifungal therapy for cryptococcosis.
• Relapse after prior therapy. The success of prior therapy must have been documented by negative 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 the study.

Prior Medication: Allowed:

• Antivirals such as zidovudine (AZT).
• Prophylaxis for Pneumocystis carinii pneumonia (including 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.
• A history of allergy to or intolerance of imidazoles or azoles.
• Moderate or severe liver disease defined by specified lab values.
• Life expectancy of < 2 weeks.

Concurrent Medication: Excluded:

• Coumarin-type anticoagulants.
• Oral hypoglycemics.
• Barbiturates.
• Phenytoin.
• Immunostimulants.
• Investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine.

Concurrent Treatment: Excluded:

• Lymphocyte replacement.

Patients with the following are excluded:

• Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
• A history of allergy to or intolerance of imidazoles or azoles.
• Moderate or severe liver disease defined by specified lab values.
• Life expectancy of < 2 weeks.

Prior Medication: Excluded:

• Coumarin-type anticoagulants.
• Oral hypoglycemics.
• Barbiturates.
• Phenytoin.
• Immunostimulants.
• Investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine.

Prior Treatment: Excluded:

• Lymphocyte replacement.

Illinois
      Cook County Hosp, Chicago,  Illinois,  60612,  United States
New Jersey
      Saint Michael's Med Ctr, Newark,  New Jersey,  07102,  United States
New York
      SUNY / Health Sciences Ctr at Brooklyn, Brooklyn,  New York,  11203,  United States
      Cabrini Med Ctr, New York,  New York,  10003,  United States

Study ID Numbers:  012K; 056-164
Record last reviewed:  December 1989
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002077
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08