A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
NCT00002304
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FOR MORE INFORMATION
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Prior Medication:
Allowed:
- Cyclosporin if levels can be monitored for proper cyclosporin dose adjustment.
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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Descriptive Information | |||
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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 |
| ||
Intervention ICMJE |
| ||
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:
Exclusion Criteria Co-existing Condition: Patients with the following are excluded:
Concurrent Medication: Excluded:
Concurrent Treatment: Excluded:
Patients with the following are excluded:
Prior Medication: Excluded:
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 |
| ||
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 |