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

Primary Purpose

Candidiasis, Esophageal, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ketoconazole
Fluconazole
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis, Esophageal focused on measuring AIDS-Related Opportunistic Infections, Immune Tolerance, Ketoconazole, Esophagitis, Fluconazole, Acquired Immunodeficiency Syndrome, Candidiasis, Oral

Eligibility Criteria

13 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Good Samaritan Med Ctr
  • Arkansas Children's Hosp
  • Los Angeles County - USC Med Ctr
  • Eisenhower Med Ctr
  • ViRx Inc
  • UCSF Hosp
  • George Washington Univ Med Ctr
  • Regional Oncology Ctr
  • Ctr for Special Immunology
  • Mem Hosp Hollywood
  • Med Ctr Clinic
  • St Petersburg Med Clinics
  • Georgia Baptist Med Ctr
  • DeKalb Gen Hosp
  • Gwinnett Med Ctr
  • Atlanta Hosp
  • Clayton Gen Hosp
  • Dr Winkler Weinberg
  • Univ Hosp
  • Baystate Med Ctr of Springfield
  • Leila Hosp and Health Care Ctr
  • Harper Hosp
  • Butterworth Hosp
  • Holland Community Hosp
  • Munson Med Ctr
  • Dr Eugene Speck
  • Univ of New Mexico School of Medicine
  • SUNY / Health Sciences Ctr at Brooklyn
  • Roswell Park Memorial Institute
  • Cornell Univ Med Ctr
  • Bowman Gray School of Medicine / North Carolina Baptist Hosp
  • Buckley Braffman Stern Med Associates
  • Wilson Brailsford Clinic
  • Baroness Erlanger Hosp
  • Univ of Tennessee
  • Univ TX Galveston Med Branch
  • Audie L Murphy Veterans Administration Hosp
  • Univ TX San Antonio Health Science Ctr
  • Infectious Disease Physicians Inc
  • McGuire Virginia Med Ctr
  • Virginia Mason Med Ctr
  • Henderson Gen Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00002304
Brief Title
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

2. Study Status

Record Verification Date
February 1990
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Esophageal, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Immune Tolerance, Ketoconazole, Esophagitis, Fluconazole, Acquired Immunodeficiency Syndrome, Candidiasis, Oral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ketoconazole
Intervention Type
Drug
Intervention Name(s)
Fluconazole

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Good Samaritan Med Ctr
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Arkansas Children's Hosp
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Eisenhower Med Ctr
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
ViRx Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States
Facility Name
UCSF Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941430654
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Regional Oncology Ctr
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32015
Country
United States
Facility Name
Ctr for Special Immunology
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Mem Hosp Hollywood
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Med Ctr Clinic
City
Pensacola
State/Province
Florida
ZIP/Postal Code
325241151
Country
United States
Facility Name
St Petersburg Med Clinics
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Georgia Baptist Med Ctr
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
DeKalb Gen Hosp
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Gwinnett Med Ctr
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30245
Country
United States
Facility Name
Atlanta Hosp
City
Riverdale
State/Province
Georgia
ZIP/Postal Code
30274
Country
United States
Facility Name
Clayton Gen Hosp
City
Riverdale
State/Province
Georgia
ZIP/Postal Code
30274
Country
United States
Facility Name
Dr Winkler Weinberg
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Univ Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Baystate Med Ctr of Springfield
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Leila Hosp and Health Care Ctr
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49016
Country
United States
Facility Name
Harper Hosp
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Butterworth Hosp
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Holland Community Hosp
City
Holland
State/Province
Michigan
ZIP/Postal Code
49423
Country
United States
Facility Name
Munson Med Ctr
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Dr Eugene Speck
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Univ of New Mexico School of Medicine
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Roswell Park Memorial Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Cornell Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Bowman Gray School of Medicine / North Carolina Baptist Hosp
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Buckley Braffman Stern Med Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Wilson Brailsford Clinic
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29304
Country
United States
Facility Name
Baroness Erlanger Hosp
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Univ of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
Audie L Murphy Veterans Administration Hosp
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Univ TX San Antonio Health Science Ctr
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States
Facility Name
McGuire Virginia Med Ctr
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Virginia Mason Med Ctr
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Henderson Gen Hosp
City
Hamilton
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
1308663
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.
Results Reference
background

Learn more about this trial

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

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