Official Title: “Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis”

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. Both newly diagnosed and relapsed patients are eligible. The effectiveness of maintenance fluconazole therapy in sustaining a clinical cure in AIDS patients will also be evaluated.

Study Type: Interventional

Study Design: Treatment, Open Label

Intervention(s) in this Clinical Trial

• Drug: Fluconazole

Inclusion Criteria

Concurrent Medication:

Allowed:

• Antivirals 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.
• 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.
• 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 except 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 except aerosolized pentamidine.

Prior Treatment:

Excluded:

• Lymphocyte replacement.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002040

Study ID Number: 012L

ClinicalTrials.gov Identifier: NCT00002040

Health Authority: United States: Food and Drug Administration