Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT00002304
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D017088', 'term': 'AIDS-Related Opportunistic Infections'}, {'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D002180', 'term': 'Candidiasis, Oral'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009894', 'term': 'Opportunistic Infections'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007654', 'term': 'Ketoconazole'}, {'id': 'D015725', 'term': 'Fluconazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1990-02', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['AIDS-Related Opportunistic Infections', 'Immune Tolerance', 'Ketoconazole', 'Esophagitis', 'Fluconazole', 'Acquired Immunodeficiency Syndrome', 'Candidiasis, Oral'], 'conditions': ['Candidiasis, Esophageal', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '1308663', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the treatment of candidal esophagitis in immunocompromised patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPrior Medication:\n\nAllowed:\n\n* Cyclosporin if levels can be monitored for proper cyclosporin dose adjustment.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Evidence of noncandidal systemic fungal infections.\n* Leukopenia (white blood cell count less than 1000/mm3), or expected to develop leukopenia during the study.\n* Other condition known to be associated with poor ketoconazole absorption, e.g., hypochlorhydria.\n* Leukemia requiring chemotherapy.\n* Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment.\n\nConcurrent Medication:\n\nExcluded:\n\n* Warfarin.\n* Immunostimulants.\n* Interferon.\n* Oral or topical antifungal agents.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Lymphocyte replacement.\n\nPatients with the following are excluded:\n\n* History of allergy to imidazoles.\n* Abnormalities which may preclude esophagoscopy or endoscopy before or during the study.\n* Inability to tolerate fluconazole or ketoconazole.\n* Inability or unwillingness to give written informed consent.\n* Life expectancy \\< 2 months.\n\nPrior Medication:\n\nExcluded:\n\n* Rifampin or ansamycin, pending clarification of drug interactions between these drugs and fluconazole.\n* Warfarin.\n\nPatients 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.\n\nIllicit or illegal drug use.'}, 'identificationModule': {'nctId': 'NCT00002304', 'briefTitle': 'A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Randomized Comparative Multicenter Trial of Fluconazole and Ketoconazole in the Treatment of Esophageal Candidiasis in Immunocompromised Patients', 'orgStudyIdInfo': {'id': '012B'}, 'secondaryIdInfos': [{'id': '056-150'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Ketoconazole', 'type': 'DRUG'}, {'name': 'Fluconazole', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Good Samaritan Med Ctr', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72202', 'city': 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