A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B

Completed · Not applicable

Conditions studied: Meningitis, Cryptococcal, HIV Infections

In brief

To evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in patients who have had an unsatisfactory response to or have experienced unacceptable toxicity with amphotericin B.

Key facts

Study ID

NCT00002306

Run by

Pfizer

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Immunosuppressant therapy.
• Antiviral therapy such as zidovudine.
• Prophylaxis for Pneumocystis carinii pneumonia.
• Aerosolized pentamidine.
• Concurrent Treatment:
• Allowed:
• Radiation therapy for mucocutaneous Kaposi's sarcoma.
• Not previously treated for acute cryptococcal meningitis and not eligible for Pfizer Central Research, protocol #159.
• Patients must have a baseline cerebrospinal fluid (CSF) culture-positive for Cryptococcus neoformans.
• Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
• Each individual patient must be approved by Pfizer Central Research prior to study entry.
• Prior Medication:
• Allowed:
• Immunosuppressant therapy.
• Antiviral therapy such as zidovudine.
• Prophylaxis for Pneumocystis carinii pneumonia.
• Aerosolized pentamidine.

You may not qualify if…

• 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 or azoles.
• Moderate or severe liver disease.
• 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.
• Satisfactory response to amphotericin B and have received a total amphotericin B dose of 15 mg/kg or more since CSF culture documentation of the current episode of acute cryptococcal meningitis.
• Life expectancy of < 2 weeks.
• Prior Medication:
• Excluded:
• Coumadin-type anticoagulants.
• Oral hypoglycemics.
• Barbiturates.
• Phenytoin.
• Immunostimulants.
• Investigational drugs or approved (licensed) drugs for investigational indications.
• Prior Treatment:
• Excluded:
• Lymphocyte replacement.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• Univ of South Florida — Tampa, Florida, United States
• Emory Univ School of Medicine — Atlanta, Georgia, United States
• Med College of Georgia — Augusta, Georgia, United States
• Univ Hosp — Boston, Massachusetts, United States
• Ann Arbor Veterans Administration Med Ctr — Ann Arbor, Michigan, United States
• Washington Univ School of Medicine — St Louis, Missouri, United States
• Saint Luke's - Roosevelt Hosp Ctr — New York, New York, United States
• Bronx Veterans Administration / Mount Sinai Hosp — The Bronx, New York, United States
• Cincinnati Veterans Adm Med Ctr / Univ Hosp — Cincinnati, Ohio, United States
• United States Air Force Med Ctr — Lackland Air Force Base, Texas, United States
• Southwest Texas Methodist Hosp — San Antonio, Texas, United States
• Univ TX San Antonio Health Science Ctr — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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