Official Title: “Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis”

To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.

Study Type: Interventional

Study Design: Treatment

Intervention(s) in this Clinical Trial

• Drug: Flucytosine
• Drug: Fluconazole
• Drug: Amphotericin B

Inclusion Criteria

Concurrent Medication:

Allowed:

• Immunosuppressant therapy.
• Antiviral therapy such as zidovudine.
• Prophylaxis for Pneumocystis carinii pneumonia.

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.
• Relapse after prior therapy.
• 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:

• Immunosuppressant therapy.
• Antiviral therapy (such as zidovudine).
• Prophylaxis for Pneumocystis carinii pneumonia.

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.
• Comatose.
• Unlikely to survive more than 2 weeks.
• Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.

Concurrent Medication:

Excluded:

• Coumadin-type anticoagulants.
• Oral hypoglycemics.
• Barbiturates.
• Phenytoin.
• Immunostimulants.
• Investigational drugs or approved (licensed) drugs for investigational indications.
• Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.
• Excluded within 4 weeks of study entry:
• Greater than 1 mg/kg/wk amphotericin B.

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, azoles, or amphotericin B.
• Moderate or severe liver disease.
• Comatose.
• Unlikely to survive more than 2 weeks.

Prior Medication:

Excluded:

• Coumadin-type anticoagulants.
• Oral hypoglycemics.
• Barbiturates.
• Phenytoin.
• Immunostimulants.
• Investigational drugs or approved (licensed) drugs for investigational indications.
• Excluded within 4 weeks of study entry:
• Greater than 1 mg/kg/wk amphotericin B.

Prior Treatment:

Excluded:

• Lymphocyte replacement.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 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 August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002305

Study ID Number: 012F

ClinicalTrials.gov Identifier: NCT00002305

Health Authority: United States: Food and Drug Administration