A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
NCT ID: NCT00002304
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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Ketoconazole
Fluconazole
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Cyclosporin if levels can be monitored for proper cyclosporin dose adjustment.
Exclusion Criteria
Patients with the following are excluded:
* Evidence of noncandidal systemic fungal infections.
* Leukopenia (white blood cell count less than 1000/mm3), or expected to develop leukopenia during the study.
* Other condition known to be associated with poor ketoconazole absorption, e.g., hypochlorhydria.
* Leukemia requiring chemotherapy.
* Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment.
Concurrent Medication:
Excluded:
* Warfarin.
* Immunostimulants.
* Interferon.
* Oral or topical antifungal agents.
Concurrent Treatment:
Excluded:
* Lymphocyte replacement.
Patients with the following are excluded:
* History of allergy to imidazoles.
* Abnormalities which may preclude esophagoscopy or endoscopy before or during the study.
* Inability to tolerate fluconazole or ketoconazole.
* Inability or unwillingness to give written informed consent.
* Life expectancy \< 2 months.
Prior Medication:
Excluded:
* Rifampin or ansamycin, pending clarification of drug interactions between these drugs and fluconazole.
* Warfarin.
Patients must meet the CDC criteria for the diagnosis of AIDS or be otherwise immunocompromised (e.g., malignancy, renal transplant) and have a diagnosis of oral candidiasis and/or esophageal symptoms of dysphagia and/or odynophagia.
Illicit or illegal drug use.
13 Years
70 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Locations
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Good Samaritan Med Ctr
Phoenix, Arizona, United States
Arkansas Children's Hosp
Little Rock, Arkansas, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
Eisenhower Med Ctr
Rancho Mirage, California, United States
ViRx Inc
San Francisco, California, United States
UCSF Hosp
San Francisco, California, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Regional Oncology Ctr
Daytona Beach, Florida, United States
Ctr for Special Immunology
Fort Lauderdale, Florida, United States
Mem Hosp Hollywood
Hollywood, Florida, United States
Med Ctr Clinic
Pensacola, Florida, United States
St Petersburg Med Clinics
St. Petersburg, Florida, United States
Georgia Baptist Med Ctr
Atlanta, Georgia, United States
DeKalb Gen Hosp
Decatur, Georgia, United States
Gwinnett Med Ctr
Lawrenceville, Georgia, United States
Atlanta Hosp
Riverdale, Georgia, United States
Clayton Gen Hosp
Riverdale, Georgia, United States
Dr Winkler Weinberg
Roswell, Georgia, United States
Univ Hosp
Boston, Massachusetts, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States
Leila Hosp and Health Care Ctr
Battle Creek, Michigan, United States
Harper Hosp
Detroit, Michigan, United States
Butterworth Hosp
Grand Rapids, Michigan, United States
Holland Community Hosp
Holland, Michigan, United States
Munson Med Ctr
Traverse City, Michigan, United States
Dr Eugene Speck
Las Vegas, Nevada, United States
Univ of New Mexico School of Medicine
Albuquerque, New Mexico, United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States
Roswell Park Memorial Institute
Buffalo, New York, United States
Cornell Univ Med Ctr
New York, New York, United States
Bowman Gray School of Medicine / North Carolina Baptist Hosp
Winston-Salem, North Carolina, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States
Wilson Brailsford Clinic
Spartanburg, South Carolina, United States
Baroness Erlanger Hosp
Chattanooga, Tennessee, United States
Univ of Tennessee
Memphis, Tennessee, United States
Univ TX Galveston Med Branch
Galveston, Texas, United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States
Infectious Disease Physicians Inc
Annandale, Virginia, United States
McGuire Virginia Med Ctr
Richmond, Virginia, United States
Virginia Mason Med Ctr
Seattle, Washington, United States
Henderson Gen Hosp
Hamilton, Ontario, Canada
Countries
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References
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Laine L, Dretler RH, Conteas CN, Tuazon C, Koster FM, Sattler F, Squires K, Islam MZ. Fluconazole compared with ketoconazole for the treatment of Candida esophagitis in AIDS. A randomized trial. Ann Intern Med. 1992 Oct 15;117(8):655-60. doi: 10.7326/0003-4819-117-8-655.
Other Identifiers
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056-150
Identifier Type: -
Identifier Source: secondary_id
012B
Identifier Type: -
Identifier Source: org_study_id