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

Launched by PFIZER · Aug 30, 2001

Keywords

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Gender

ALL

Eligibility 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.