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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
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

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

  Show 42 Study Locations
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

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

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 September 01, 2009