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

Completed · Not applicable

Conditions studied: Candidiasis, Esophageal, HIV Infections

In brief

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

Key facts

Study ID

NCT00002304

Run by

Pfizer

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prior Medication:
• Allowed:
• Cyclosporin if levels can be monitored for proper cyclosporin dose adjustment.

You may not qualify if…

• 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.

Where it is running

• Good Samaritan Med Ctr — Phoenix, Arizona, United States
• Arkansas Children's Hosp — Little Rock, Arkansas, United States
• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• Eisenhower Med Ctr — Rancho Mirage, California, United States
• ViRx Inc — San Francisco, California, United States
• UCSF Hosp — San Francisco, California, United States
• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• Regional Oncology Ctr — Daytona Beach, Florida, United States
• Ctr for Special Immunology — Fort Lauderdale, Florida, United States
• Mem Hosp Hollywood — Hollywood, Florida, United States
• Med Ctr Clinic — Pensacola, Florida, United States
• St Petersburg Med Clinics — St. Petersburg, Florida, United States
• Georgia Baptist Med Ctr — Atlanta, Georgia, United States
• DeKalb Gen Hosp — Decatur, Georgia, United States
• Gwinnett Med Ctr — Lawrenceville, Georgia, United States
• Atlanta Hosp — Riverdale, Georgia, United States
• Clayton Gen Hosp — Riverdale, Georgia, United States
• Dr Winkler Weinberg — Roswell, Georgia, United States
• Univ Hosp — Boston, Massachusetts, United States
• Baystate Med Ctr of Springfield — Springfield, Massachusetts, United States
• Leila Hosp and Health Care Ctr — Battle Creek, Michigan, United States
• Harper Hosp — Detroit, Michigan, United States
• Butterworth Hosp — Grand Rapids, Michigan, United States
• Holland Community Hosp — Holland, Michigan, United States
• Munson Med Ctr — Traverse City, Michigan, United States

Full record on ClinicalTrials.gov

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