HIV Infections Clinical Trial
Official title:
A Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
NCT number | NCT00002304 |
Other study ID # | 012B |
Secondary ID | 056-150 |
Status | Completed |
Phase | N/A |
First received | November 2, 1999 |
Last updated | June 23, 2005 |
To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 13 Years to 70 Years |
Eligibility |
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. |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Henderson Gen Hosp | Hamilton | Ontario |
United States | Univ of New Mexico School of Medicine | Albuquerque | New Mexico |
United States | Infectious Disease Physicians Inc | Annandale | Virginia |
United States | Georgia Baptist Med Ctr | Atlanta | Georgia |
United States | Leila Hosp and Health Care Ctr | Battle Creek | Michigan |
United States | Univ Hosp | Boston | Massachusetts |
United States | SUNY / Health Sciences Ctr at Brooklyn | Brooklyn | New York |
United States | Roswell Park Memorial Institute | Buffalo | New York |
United States | Baroness Erlanger Hosp | Chattanooga | Tennessee |
United States | Regional Oncology Ctr | Daytona Beach | Florida |
United States | DeKalb Gen Hosp | Decatur | Georgia |
United States | Harper Hosp | Detroit | Michigan |
United States | Ctr for Special Immunology | Fort Lauderdale | Florida |
United States | Univ TX Galveston Med Branch | Galveston | Texas |
United States | Butterworth Hosp | Grand Rapids | Michigan |
United States | Holland Community Hosp | Holland | Michigan |
United States | Mem Hosp Hollywood | Hollywood | Florida |
United States | Dr Eugene Speck | Las Vegas | Nevada |
United States | Gwinnett Med Ctr | Lawrenceville | Georgia |
United States | Arkansas Children's Hosp | Little Rock | Arkansas |
United States | Los Angeles County - USC Med Ctr | Los Angeles | California |
United States | Univ of Tennessee | Memphis | Tennessee |
United States | Cornell Univ Med Ctr | New York | New York |
United States | Med Ctr Clinic | Pensacola | Florida |
United States | Buckley Braffman Stern Med Associates | Philadelphia | Pennsylvania |
United States | Good Samaritan Med Ctr | Phoenix | Arizona |
United States | Eisenhower Med Ctr | Rancho Mirage | California |
United States | McGuire Virginia Med Ctr | Richmond | Virginia |
United States | Atlanta Hosp | Riverdale | Georgia |
United States | Clayton Gen Hosp | Riverdale | Georgia |
United States | Dr Winkler Weinberg | Roswell | Georgia |
United States | Audie L Murphy Veterans Administration Hosp | San Antonio | Texas |
United States | Univ TX San Antonio Health Science Ctr | San Antonio | Texas |
United States | UCSF Hosp | San Francisco | California |
United States | ViRx Inc | San Francisco | California |
United States | Virginia Mason Med Ctr | Seattle | Washington |
United States | Wilson Brailsford Clinic | Spartanburg | South Carolina |
United States | Baystate Med Ctr of Springfield | Springfield | Massachusetts |
United States | St Petersburg Med Clinics | St Petersburg | Florida |
United States | Munson Med Ctr | Traverse City | Michigan |
United States | George Washington Univ Med Ctr | Washington | District of Columbia |
United States | Bowman Gray School of Medicine / North Carolina Baptist Hosp | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Canada,
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. — View Citation
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