- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002306
A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B
Multi-Center Evaluation of Fluconazole (UK-49,858) as Treatment for Acute Cryptococcal Meningitis in Patients Who Have Failed to Respond or Have Experienced Unacceptable Toxicity During Treatment With Amphotericin B
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- Univ of Alabama at Birmingham
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District of Columbia
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Washington, District of Columbia, United States, 20037
- George Washington Univ Med Ctr
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Florida
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Tampa, Florida, United States, 33612
- Univ of South Florida
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Georgia
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Atlanta, Georgia, United States, 30303
- Emory Univ School of Medicine
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Augusta, Georgia, United States, 30912
- Med College of Georgia
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Univ Hosp
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Michigan
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Ann Arbor, Michigan, United States, 48105
- Ann Arbor Veterans Administration Med Ctr
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Missouri
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St. Louis, Missouri, United States, 63108
- Washington Univ School of Medicine
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New York
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Bronx, New York, United States, 10468
- Bronx Veterans Administration / Mount Sinai Hosp
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New York, New York, United States, 10025
- Saint Luke's - Roosevelt Hosp Ctr
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Ohio
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Cincinnati, Ohio, United States, 452670405
- Cincinnati Veterans Adm Med Ctr / Univ Hosp
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Texas
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Lackland Air Force Base, Texas, United States, 782365300
- United States Air Force Med Ctr
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San Antonio, Texas, United States, 78229
- Southwest Texas Methodist Hosp
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San Antonio, Texas, United States, 78284
- Univ TX San Antonio Health Science Ctr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
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.
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 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Central Nervous System Infections
- Bacterial Infections and Mycoses
- Mycoses
- Meningitis, Fungal
- Central Nervous System Fungal Infections
- Cryptococcosis
- Meningitis
- Meningitis, Cryptococcal
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Fluconazole
Other Study ID Numbers
- 012I
- 056-161
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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