To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients...
Date First Received: November 2, 1999
Last Updated: June 23, 2005
Verified by: NIH AIDS Clinical Trials Information Service, February 1990
Clinical Trial Phase: N/A | Start Date:
Overall Status: Completed
Brief Summary
Official Title: “A Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients”
Condition Keyword(s):
Intervention(s):
To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.
Study Type: Interventional
Study Design: Treatment
Intervention(s) in this Clinical Trial
- Drug: Ketoconazole
- Drug: Fluconazole
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 13 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Pfizer
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002304
Study ID Number: 012B
ClinicalTrials.gov Identifier: NCT00002304
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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