Official Title: “Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis”

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.

Study Type: Interventional

Study Design: Treatment

Intervention(s) in this Clinical Trial

• Drug: Fluconazole

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.

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 September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002076

Study ID Number: 012J

ClinicalTrials.gov Identifier: NCT00002076

Health Authority: United States: Food and Drug Administration