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.

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.