We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00002304
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
Last Verified: February 1990

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:
Infection
Communicable Diseases
HIV Infections
Candidiasis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mycoses
Ketoconazole
Fluconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors