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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.
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
November 2, 1999
August 31, 2001
March 17, 2014
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No Changes Posted
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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
A Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.
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Interventional
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Primary Purpose: Treatment
  • Candidiasis, Esophageal
  • HIV Infections
  • Drug: Ketoconazole
  • Drug: Fluconazole
Not Provided
Laine L, Dretler RH, Conteas CN, Tuazon C, Koster FM, Sattler F, Squires K, Islam MZ. Fluconazole compared with ketoconazole for the treatment of Candida esophagitis in AIDS. A randomized trial. Ann Intern Med. 1992 Oct 15;117(8):655-60.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Sexes Eligible for Study: All
13 Years to 70 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00002304
012B
056-150
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Pfizer
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NIH AIDS Clinical Trials Information Service
February 1990

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP