Candidiasis, Esophageal, HIV Infections
Conditions
Keywords
AIDS-Related Opportunistic Infections, Immune Tolerance, Ketoconazole, Esophagitis, Fluconazole, Acquired Immunodeficiency Syndrome, Candidiasis, Oral
Brief summary
To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.
Interventions
DRUGKetoconazole
DRUGFluconazole
Sponsors
Pfizer
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
13 Years to 70 Years
Healthy volunteers
No
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.
Countries
Canada, United States
Outcome results
None listed