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

HIV Infections Clinical Trial

Official title:

A Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients

Clinical Trial Details — Status: Completed

Administrative data

• 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

Study information

• Verified date: February 1990
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• 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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Esophageal
• HIV Infections
• Infection

Intervention

Drug:
• Ketoconazole

• Fluconazole

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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