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A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsor: Pfizer
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002304
  Purpose

To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.


Condition Intervention
Candidiasis, Esophageal
HIV Infections
Drug: Ketoconazole
Drug: Fluconazole

Study Type: Interventional
Study Design: Treatment
Official Title: A Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   13 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Prior Medication:

Allowed:

  • Cyclosporin if levels can be monitored for proper cyclosporin dose adjustment.

Exclusion Criteria

Co-existing Condition:

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002304

  Hide Study Locations
Locations
United States, Arizona
Good Samaritan Med Ctr
Phoenix, Arizona, United States, 85006
United States, Arkansas
Arkansas Children's Hosp
Little Rock, Arkansas, United States, 72202
United States, California
UCSF Hosp
San Francisco, California, United States, 941430654
ViRx Inc
San Francisco, California, United States, 94103
Eisenhower Med Ctr
Rancho Mirage, California, United States, 92270
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Florida
Med Ctr Clinic
Pensacola, Florida, United States, 325241151
Regional Oncology Ctr
Daytona Beach, Florida, United States, 32015
St Petersburg Med Clinics
St. Petersburg, Florida, United States, 33705
Ctr for Special Immunology
Fort Lauderdale, Florida, United States, 33308
Mem Hosp Hollywood
Hollywood, Florida, United States, 33021
United States, Georgia
DeKalb Gen Hosp
Decatur, Georgia, United States, 30033
Dr Winkler Weinberg
Roswell, Georgia, United States, 30076
Atlanta Hosp
Riverdale, Georgia, United States, 30274
Clayton Gen Hosp
Riverdale, Georgia, United States, 30274
Georgia Baptist Med Ctr
Atlanta, Georgia, United States, 30338
Gwinnett Med Ctr
Lawrenceville, Georgia, United States, 30245
United States, Massachusetts
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
Univ Hosp
Boston, Massachusetts, United States, 02118
United States, Michigan
Butterworth Hosp
Grand Rapids, Michigan, United States, 49503
Holland Community Hosp
Holland, Michigan, United States, 49423
Harper Hosp
Detroit, Michigan, United States, 48201
Leila Hosp and Health Care Ctr
Battle Creek, Michigan, United States, 49016
Munson Med Ctr
Traverse City, Michigan, United States, 49684
United States, Nevada
Dr Eugene Speck
Las Vegas, Nevada, United States, 89109
United States, New Mexico
Univ of New Mexico School of Medicine
Albuquerque, New Mexico, United States, 87131
United States, New York
Cornell Univ Med Ctr
New York, New York, United States, 10021
Roswell Park Memorial Institute
Buffalo, New York, United States, 14263
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 11203
United States, North Carolina
Bowman Gray School of Medicine / North Carolina Baptist Hosp
Winston Salem, North Carolina, United States, 27103
United States, Pennsylvania
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Wilson Brailsford Clinic
Spartanburg, South Carolina, United States, 29304
United States, Tennessee
Baroness Erlanger Hosp
Chattanooga, Tennessee, United States, 37403
Univ of Tennessee
Memphis, Tennessee, United States, 38163
United States, Texas
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, United States, 78284
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States, 78284
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550
United States, Virginia
Infectious Disease Physicians Inc
Annandale, Virginia, United States, 22203
McGuire Virginia Med Ctr
Richmond, Virginia, United States, 23249
United States, Washington
Virginia Mason Med Ctr
Seattle, Washington, United States, 98101
Canada, Ontario
Henderson Gen Hosp
Hamilton, Ontario, Canada
Sponsors and Collaborators
Pfizer
  More Information

Publications:
Study ID Numbers: 012B, 056-150
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002304     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Immune Tolerance
Ketoconazole
Esophagitis
Fluconazole
Acquired Immunodeficiency Syndrome
Candidiasis, Oral

Additional relevant MeSH terms:
Fluconazole
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Candidiasis
Gastrointestinal Diseases
Acquired Immunodeficiency Syndrome
Ketoconazole
Infection
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
Digestive System Diseases
HIV Infections
Therapeutic Uses
Antifungal Agents
Sexually Transmitted Diseases
Lentivirus Infections
Esophageal Diseases
Retroviridae Infections

ClinicalTrials.gov processed this record on November 27, 2009