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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002304
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 1990
  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: Primary Purpose: 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:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Eisenhower Med Ctr
Rancho Mirage, California, United States, 92270
UCSF Hosp
San Francisco, California, United States, 941430654
ViRx Inc
San Francisco, California, United States, 94103
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Florida
Regional Oncology Ctr
Daytona Beach, Florida, United States, 32015
Ctr for Special Immunology
Fort Lauderdale, Florida, United States, 33308
Mem Hosp Hollywood
Hollywood, Florida, United States, 33021
Med Ctr Clinic
Pensacola, Florida, United States, 325241151
St Petersburg Med Clinics
St Petersburg, Florida, United States, 33705
United States, Georgia
Georgia Baptist Med Ctr
Atlanta, Georgia, United States, 30338
DeKalb Gen Hosp
Decatur, Georgia, United States, 30033
Gwinnett Med Ctr
Lawrenceville, Georgia, United States, 30245
Atlanta Hosp
Riverdale, Georgia, United States, 30274
Clayton Gen Hosp
Riverdale, Georgia, United States, 30274
Dr Winkler Weinberg
Roswell, Georgia, United States, 30076
United States, Massachusetts
Univ Hosp
Boston, Massachusetts, United States, 02118
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
United States, Michigan
Leila Hosp and Health Care Ctr
Battle Creek, Michigan, United States, 49016
Harper Hosp
Detroit, Michigan, United States, 48201
Butterworth Hosp
Grand Rapids, Michigan, United States, 49503
Holland Community Hosp
Holland, Michigan, United States, 49423
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
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 11203
Roswell Park Memorial Institute
Buffalo, New York, United States, 14263
Cornell Univ Med Ctr
New York, New York, United States, 10021
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
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77550
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
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:
ClinicalTrials.gov Identifier: NCT00002304     History of Changes
Other Study ID Numbers: 012B, 056-150
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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:
HIV Infections
Acquired Immunodeficiency Syndrome
Candidiasis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycoses
Fluconazole
Ketoconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014