A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis
NCT ID: NCT00002305
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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Flucytosine
Fluconazole
Amphotericin B
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
Tucson Veterans Administration Med Ctr
Tucson, Arizona, United States
UCLA CARE Ctr
Los Angeles, California, United States
Dr Shelly Gordon
San Francisco, California, United States
Dr Martin Mass
San Francisco, California, United States
Dr Paul Rothman
Sherman Oaks, California, United States
Christiana Hosp / Med Ctr of Delaware
Wilmington, Delaware, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Univ of Miami School of Medicine
Miami, Florida, 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
DeKalb Gen Hosp
Decatur, Georgia, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Louisiana State Univ School of Medicine
New Orleans, Louisiana, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, United States
Dr Michael Bach
Portland, Maine, United States
Univ of Maryland / Inst of Human Virology
Baltimore, Maryland, United States
Loch Raven Veterans Hosp
Baltimore, Maryland, United States
New England Med Ctr
Boston, Massachusetts, United States
Univ Hosp
Boston, Massachusetts, United States
Ann Arbor Veterans Administration Med Ctr
Ann Arbor, Michigan, United States
Harper Hosp
Detroit, Michigan, United States
Henry Ford Hosp
Detroit, Michigan, United States
Washington Univ School of Medicine
St Louis, Missouri, United States
Albany Med College / AIDS Treatment Ctr
Albany, New York, United States
Jewish Hosp Ctr Affiliation
Jamaica, New York, United States
Chelsea Village Med Ctr
New York, New York, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States
Columbia Univ
New York, New York, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States
Montefiore Med Ctr / Bronx Municipal Hosp
The Bronx, New York, United States
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, United States
Univ of North Carolina School of Medicine
Chapel Hill, North Carolina, United States
Cincinnati Veterans Adm Med Ctr / Univ Hosp
Cincinnati, Ohio, United States
Ohio State Univ Hosp
Columbus, Ohio, United States
Univ of Tennessee
Memphis, Tennessee, United States
Dr Daniel Barbaro
Dallas, Texas, United States
Univ TX Galveston Med Branch
Galveston, Texas, United States
United States Air Force Med Ctr
Lackland Air Force Base, Texas, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States
Richmond AIDS Consortium
Richmond, Virginia, United States
CHG-118 Group Health / Cooperative of Puget Sound
Seattle, Washington, United States
Saint Michael's Hosp
Toronto, Ontario, Canada
Countries
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Other Identifiers
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056-159
Identifier Type: -
Identifier Source: secondary_id
012F
Identifier Type: -
Identifier Source: org_study_id