Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-01-01 @ 6:35 PM
Study NCT ID:
NCT00002068
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016919', 'term': 'Meningitis, Cryptococcal'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D017088', 'term': 'AIDS-Related Opportunistic Infections'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D003453', 'term': 'Cryptococcosis'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D016921', 'term': 'Meningitis, Fungal'}, {'id': 'D020314', 'term': 'Central Nervous System Fungal Infections'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'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': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015725', 'term': 'Fluconazole'}, {'id': 'D000666', 'term': 'Amphotericin B'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, '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', 'Meningitis', 'Cryptococcosis', 'Drug Therapy, Combination', 'Fluconazole', 'Flucytosine', 'Acquired Immunodeficiency Syndrome', 'Amphotericin B'], 'conditions': ['Meningitis, Cryptococcal', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Immunosuppressant therapy.\n* Antiviral therapy such as zidovudine.\n* Prophylaxis for Pneumocystis carinii pneumonia.\n\nConcurrent Treatment:\n\nAllowed:\n\n* Radiation therapy for mucocutaneous Kaposi's sarcoma.\n\nWritten informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.\n\n* No prior systemic antifungal therapy for cryptococcosis.\n* Relapse after prior therapy.\n* Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study.\n\nPrior Medication:\n\nAllowed:\n\n* Immunosuppressant therapy.\n* Antiviral therapy such as zidovudine.\n* Prophylaxis for Pneumocystis carinii pneumonia.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.\n* History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.\n* Moderate or severe liver disease.\n* Comatose.\n* Unlikely to survive more than 2 weeks.\n\nConcurrent Medication:\n\nExcluded within 4 weeks of study entry:\n\n* Greater than 1 mg/kg/wk amphotericin B.\n* Coumadin-type anticoagulants.\n* Oral hypoglycemics.\n* Barbiturates.\n* Phenytoin.\n* Immunostimulants.\n* Investigational drugs or approved (licensed) drugs for investigational indications.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Lymphocyte replacement.\n\nPatients with the following are excluded:\n\n* Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.\n* History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.\n* Moderate or severe liver disease.\n* Comatose.\n* Unlikely to survive more than 2 weeks.\n\nPrior Medication:\n\nExcluded within 4 weeks of study entry:\n\n* Greater than 1 mg/kg/wk amphotericin B.\n* Coumadin-type anticoagulants.\n* Oral hypoglycemics.\n* Barbiturates.\n* Phenytoin.\n* Immunostimulants.\n* Investigational drugs or approved (licensed) drugs for investigational indications.\n\nPrior Treatment:\n\nExcluded:\n\n* Lymphocyte replacement."}, 'identificationModule': {'nctId': 'NCT00002068', 'briefTitle': 'A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis', 'orgStudyIdInfo': {'id': '012H'}, 'secondaryIdInfos': [{'id': '056-159B'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Fluconazole', 'type': 'DRUG'}, {'name': 'Amphotericin B', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94114', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Davies Med Ctr', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '19899', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Hosp / Med Ctr of Delaware', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '212011192', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Univ of Maryland / Inst of Human Virology', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hosp', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10037', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Harlem AIDS Treatment Group / Harlem Hosp Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Univ of Tennessee', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Saint Michael's Hosp", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}}}}