A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B
NCT ID: NCT00002306
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Fluconazole
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
13 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Locations
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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
Countries
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Other Identifiers
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056-161
Identifier Type: -
Identifier Source: secondary_id
012I
Identifier Type: -
Identifier Source: org_study_id