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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.

Sponsored by: 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

MedlinePlus related topics:   AIDS    Esophagus Disorders    Yeast Infections   

Drug Information available for:   Ketoconazole    Fluconazole   

U.S. FDA Resources

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
  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

Show 42 study locations  Show 42 Study Locations

Sponsors and Collaborators
Pfizer
  More Information


Publications:

Study ID Numbers:   012B, 056-150
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002304
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

Study placed in the following topic categories:
Fluconazole
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Candidiasis, Oral
Esophageal disorder
Candidiasis
Clotrimazole
Gastrointestinal Diseases
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Ketoconazole
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
Esophagitis
Digestive System Diseases
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Esophageal Diseases
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses
Antifungal Agents
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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