Clinical trial NCT00002304: A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
Official title: A Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Candidiasis, Esophageal
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Immune Tolerance
Ketoconazole
Esophagitis
Fluconazole
Acquired Immunodeficiency Syndrome
Candidiasis, Oral
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Good Samaritan Med Ctr
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hosp
state: Arkansas
city: Los Angeles
country: United States
facility: Los Angeles County - USC Med Ctr
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Med Ctr
state: California
city: San Francisco
country: United States
facility: ViRx Inc
state: California
city: San Francisco
country: United States
facility: UCSF Hosp
state: California
city: Washington
country: United States
facility: George Washington Univ Med Ctr
state: District of Columbia
city: Daytona Beach
country: United States
facility: Regional Oncology Ctr
state: Florida
city: Fort Lauderdale
country: United States
facility: Ctr for Special Immunology
state: Florida
city: Hollywood
country: United States
facility: Mem Hosp Hollywood
state: Florida
city: Pensacola
country: United States
facility: Med Ctr Clinic
state: Florida
city: St Petersburg
country: United States
facility: St Petersburg Med Clinics
state: Florida
city: Atlanta
country: United States
facility: Georgia Baptist Med Ctr
state: Georgia
city: Decatur
country: United States
facility: DeKalb Gen Hosp
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Med Ctr
state: Georgia
city: Riverdale
country: United States
facility: Atlanta Hosp
state: Georgia
city: Riverdale
country: United States
facility: Clayton Gen Hosp
state: Georgia
city: Roswell
country: United States
facility: Dr Winkler Weinberg
state: Georgia
city: Boston
country: United States
facility: Univ Hosp
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Med Ctr of Springfield
state: Massachusetts
city: Battle Creek
country: United States
facility: Leila Hosp and Health Care Ctr
state: Michigan
city: Detroit
country: United States
facility: Harper Hosp
state: Michigan
city: Grand Rapids
country: United States
facility: Butterworth Hosp
state: Michigan
city: Holland
country: United States
facility: Holland Community Hosp
state: Michigan
city: Traverse City
country: United States
facility: Munson Med Ctr
state: Michigan
city: Las Vegas
country: United States
facility: Dr Eugene Speck
state: Nevada
city: Albuquerque
country: United States
facility: Univ of New Mexico School of Medicine
state: New Mexico
city: Brooklyn
country: United States
facility: SUNY / Health Sciences Ctr at Brooklyn
state: New York
city: Buffalo
country: United States
facility: Roswell Park Memorial Institute
state: New York
city: New York
country: United States
facility: Cornell Univ Med Ctr
state: New York
city: Winston-Salem
country: United States
facility: Bowman Gray School of Medicine / North Carolina Baptist Hosp
state: North Carolina
city: Philadelphia
country: United States
facility: Buckley Braffman Stern Med Associates
state: Pennsylvania
city: Spartanburg
country: United States
facility: Wilson Brailsford Clinic
state: South Carolina
city: Chattanooga
country: United States
facility: Baroness Erlanger Hosp
state: Tennessee
city: Memphis
country: United States
facility: Univ of Tennessee
state: Tennessee
city: Galveston
country: United States
facility: Univ TX Galveston Med Branch
state: Texas
city: San Antonio
country: United States
facility: Audie L Murphy Veterans Administration Hosp
state: Texas
city: San Antonio
country: United States
facility: Univ TX San Antonio Health Science Ctr
state: Texas
city: Annandale
country: United States
facility: Infectious Disease Physicians Inc
state: Virginia
city: Richmond
country: United States
facility: McGuire Virginia Med Ctr
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Med Ctr
state: Washington
city: Hamilton
country: Canada
facility: Henderson Gen Hosp
state: Ontario
Study officials:
References:
citation: 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. doi: 10.7326/0003-4819-117-8-655.