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

NCT00002304

Last updated date
Study Location
Good Samaritan Med Ctr
Phoenix, Arizona, 85006, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Candidiasis, Esophageal, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Prior Medication:

Allowed:

- Cyclosporin if levels can be monitored for proper cyclosporin dose adjustment.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Candidiasis, Esophageal, HIV InfectionsA Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
NCT00002304
  1. Phoenix, Arizona
  2. Little Rock, Arkansas
  3. Los Angeles, California
  4. Rancho Mirage, California
  5. San Francisco, California
  6. San Francisco, California
  7. Washington, District of Columbia
  8. Daytona Beach, Florida
  9. Fort Lauderdale, Florida
  10. Hollywood, Florida
  11. Pensacola, Florida
  12. St Petersburg, Florida
  13. Atlanta, Georgia
  14. Decatur, Georgia
  15. Lawrenceville, Georgia
  16. Riverdale, Georgia
  17. Riverdale, Georgia
  18. Roswell, Georgia
  19. Boston, Massachusetts
  20. Springfield, Massachusetts
  21. Battle Creek, Michigan
  22. Detroit, Michigan
  23. Grand Rapids, Michigan
  24. Holland, Michigan
  25. Traverse City, Michigan
  26. Las Vegas, Nevada
  27. Albuquerque, New Mexico
  28. Brooklyn, New York
  29. Buffalo, New York
  30. New York, New York
  31. Winston-Salem, North Carolina
  32. Philadelphia, Pennsylvania
  33. Spartanburg, South Carolina
  34. Chattanooga, Tennessee
  35. Memphis, Tennessee
  36. Galveston, Texas
  37. San Antonio, Texas
  38. San Antonio, Texas
  39. Annandale, Virginia
  40. Richmond, Virginia
  41. Seattle, Washington
  42. Hamilton, Ontario
ALL GENDERS
13 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
Official Title  ICMJE A Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
Brief Summary To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Candidiasis, Esophageal
  • HIV Infections
Intervention  ICMJE
  • Drug: Ketoconazole
  • Drug: Fluconazole
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 13 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002304
Other Study ID Numbers  ICMJE 012B
056-150
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NIH AIDS Clinical Trials Information Service
Verification Date February 1990

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP