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

Pfizer

Status: Completed

Conditions: Candidiasis, Esophageal; HIV Infections

Treatments: Drug: Ketoconazole; Drug: Fluconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002304

056-150

012B

Details and patient eligibility

About

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

Sex: All

Ages: 13 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.