A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Fluconazole; Ketoconazole

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.