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

Condition	Treatment or Intervention
Candidiasis, esophageal HIV Infections	Drug: Ketoconazole  Drug: Fluconazole

Ages Eligible for Study:  13 Years   -   70 Years,  Genders Eligible for Study:  Both

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.

Arizona
      Good Samaritan Med Ctr, Phoenix,  Arizona,  85006,  United States
Arkansas
      Arkansas Children's Hosp, Little Rock,  Arkansas,  72202,  United States
California
      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
District of Columbia
      George Washington Univ Med Ctr, Washington,  District of Columbia,  20037,  United States
Florida
      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
Georgia
      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
Massachusetts
      Baystate Med Ctr of Springfield, Springfield,  Massachusetts,  01199,  United States
      Univ Hosp, Boston,  Massachusetts,  02118,  United States
Michigan
      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
Nevada
      Dr Eugene Speck, Las Vegas,  Nevada,  89109,  United States
New Mexico
      Univ of New Mexico School of Medicine, Albuquerque,  New Mexico,  87131,  United States
New York
      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
North Carolina
      Bowman Gray School of Medicine / North Carolina Baptist Hosp, Winston Salem,  North Carolina,  27103,  United States
Pennsylvania
      Buckley Braffman Stern Med Associates, Philadelphia,  Pennsylvania,  19107,  United States
South Carolina
      Wilson Brailsford Clinic, Spartanburg,  South Carolina,  29304,  United States
Tennessee
      Baroness Erlanger Hosp, Chattanooga,  Tennessee,  37403,  United States
      Univ of Tennessee, Memphis,  Tennessee,  38163,  United States
Texas
      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
Virginia
      Infectious Disease Physicians Inc, Annandale,  Virginia,  22203,  United States
      McGuire Virginia Med Ctr, Richmond,  Virginia,  23249,  United States
Washington
      Virginia Mason Med Ctr, Seattle,  Washington,  98101,  United States
Canada, Ontario
      Henderson Gen Hosp, Hamilton,  Ontario,  Canada

Study ID Numbers:  012B; 056-150
Record last reviewed:  February 1990
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002304
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08