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.
Good Samaritan Med Ctr, Phoenix, Arizona 85006, United States
Arkansas Children's Hosp, Little Rock, Arkansas 72202, United States
UCSF Hosp, San Francisco, California 941430654, United States
ViRx Inc, San Francisco, California 94103, United States
Eisenhower Med Ctr, Rancho Mirage, California 92270, United States
Los Angeles County - USC Med Ctr, Los Angeles, California 90033, United States
George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States
Med Ctr Clinic, Pensacola, Florida 325241151, United States
Regional Oncology Ctr, Daytona Beach, Florida 32015, United States
St Petersburg Med Clinics, St. Petersburg, Florida 33705, United States
Ctr for Special Immunology, Fort Lauderdale, Florida 33308, United States
Mem Hosp Hollywood, Hollywood, Florida 33021, United States
DeKalb Gen Hosp, Decatur, Georgia 30033, United States
Dr Winkler Weinberg, Roswell, Georgia 30076, United States
Atlanta Hosp, Riverdale, Georgia 30274, United States
Clayton Gen Hosp, Riverdale, Georgia 30274, United States
Georgia Baptist Med Ctr, Atlanta, Georgia 30338, United States
Gwinnett Med Ctr, Lawrenceville, Georgia 30245, United States
Baystate Med Ctr of Springfield, Springfield, Massachusetts 01199, United States
Univ Hosp, Boston, Massachusetts 02118, United States
Butterworth Hosp, Grand Rapids, Michigan 49503, United States
Holland Community Hosp, Holland, Michigan 49423, United States
Harper Hosp, Detroit, Michigan 48201, United States
Leila Hosp and Health Care Ctr, Battle Creek, Michigan 49016, United States
Munson Med Ctr, Traverse City, Michigan 49684, United States
Dr Eugene Speck, Las Vegas, Nevada 89109, United States
Univ of New Mexico School of Medicine, Albuquerque, New Mexico 87131, United States
Cornell Univ Med Ctr, New York, New York 10021, United States
Roswell Park Memorial Institute, Buffalo, New York 14263, United States
SUNY / Health Sciences Ctr at Brooklyn, Brooklyn, New York 11203, United States
Bowman Gray School of Medicine / North Carolina Baptist Hosp, Winston Salem, North Carolina 27103, United States
Henderson Gen Hosp, Hamilton, Ontario, Canada
Buckley Braffman Stern Med Associates, Philadelphia, Pennsylvania 19107, United States
Wilson Brailsford Clinic, Spartanburg, South Carolina 29304, United States
Baroness Erlanger Hosp, Chattanooga, Tennessee 37403, United States
Univ of Tennessee, Memphis, Tennessee 38163, United States
Audie L Murphy Veterans Administration Hosp, San Antonio, Texas 78284, United States
Univ TX San Antonio Health Science Ctr, San Antonio, Texas 78284, United States
Univ TX Galveston Med Branch, Galveston, Texas 77550, United States
Infectious Disease Physicians Inc, Annandale, Virginia 22203, United States
McGuire Virginia Med Ctr, Richmond, Virginia 23249, United States
Virginia Mason Med Ctr, Seattle, Washington 98101, United States
Laine L, Dretler RH, Conteas CN, Tuazon C, Koster FM, Sattler F, Squires K, Islam MZ. Fluconazole compared with ketoconazole for the treatment of Candida esophagitis in AIDS. A randomized trial. Ann Intern Med. 1992 Oct 15;117(8):655-60.
