Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT00002305
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 Amphotericin B in the Treatment of 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': 'D005437', 'term': 'Flucytosine'}, {'id': 'D015725', 'term': 'Fluconazole'}, {'id': 'D000666', 'term': 'Amphotericin B'}], 'ancestors': [{'id': 'D003596', 'term': 'Cytosine'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'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': '1989-12', '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': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 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* Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.\n\nConcurrent Medication:\n\nExcluded:\n\n* Coumadin-type anticoagulants.\n* Oral hypoglycemics.\n* Barbiturates.\n* Phenytoin.\n* Immunostimulants.\n* Investigational drugs or approved (licensed) drugs for investigational indications.\n* Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.\n* Excluded within 4 weeks of study entry:\n* Greater than 1 mg/kg/wk amphotericin B.\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:\n\n* Coumadin-type anticoagulants.\n* Oral hypoglycemics.\n* Barbiturates.\n* Phenytoin.\n* Immunostimulants.\n* Investigational drugs or approved (licensed) drugs for investigational indications.\n* Excluded within 4 weeks of study entry:\n* Greater than 1 mg/kg/wk amphotericin B.\n\nPrior Treatment:\n\nExcluded:\n\n* Lymphocyte replacement."}, 'identificationModule': {'nctId': 'NCT00002305', 'briefTitle': 'A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis', 'orgStudyIdInfo': {'id': '012F'}, 'secondaryIdInfos': [{'id': '056-159'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Flucytosine', 'type': 'DRUG'}, {'name': 'Fluconazole', 'type': 'DRUG'}, {'name': 'Amphotericin B', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Univ of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tucson Veterans Administration Med Ctr', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA CARE Ctr', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Dr Shelly Gordon', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94120', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Dr Martin Mass', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'Dr Paul Rothman', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '19899', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Hosp / Med Ctr of Delaware', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington Univ Med Ctr', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '331361013', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ of Miami School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Univ School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Med College of Georgia', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'DeKalb Gen Hosp', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Univ Med School', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State Univ School of Medicine', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Univ School of Medicine', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Dr Michael Bach', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'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': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Loch Raven Veterans Hosp', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Med Ctr', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Univ Hosp', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Ann Arbor Veterans Administration Med Ctr', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Harper Hosp', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hosp', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington Univ School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '12203', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Med College / AIDS Treatment Ctr', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11432', 'city': 'Jamaica', 'state': 'New York', 'country': 'United States', 'facility': 'Jewish Hosp Ctr Affiliation', 'geoPoint': {'lat': 40.69149, 'lon': -73.80569}}, {'zip': '10014', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Chelsea Village Med Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mem Sloan - Kettering Cancer Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10025', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Saint Luke's - Roosevelt Hosp Ctr", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia Univ', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'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': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Med Ctr / Bronx Municipal Hosp', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10468', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Bronx Veterans Administration / Mount Sinai Hosp', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '275997215', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Univ of North Carolina School of Medicine', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '452670405', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Veterans Adm Med Ctr / Univ Hosp', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State Univ Hosp', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Univ of Tennessee', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dr Daniel Barbaro', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77550', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ TX Galveston Med Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '782365300', 'city': 'Lackland Air Force Base', 'state': 'Texas', 'country': 'United States', 'facility': 'United States Air Force Med Ctr', 'geoPoint': {'lat': 29.38663, 'lon': -98.61797}}, {'zip': '78284', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ TX San Antonio Health Science Ctr', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23219', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Richmond AIDS Consortium', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98112', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'CHG-118 Group Health / Cooperative of Puget Sound', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Saint Michael's Hosp", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}}}}