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

  Show 42 Study Locations
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:
Acquired Immunodeficiency Syndrome
Candidiasis
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mycoses
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Fluconazole
Ketoconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014