Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-28 @ 3:37 AM
Study NCT ID:
NCT00002159
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006660', 'term': 'Histoplasmosis'}, {'id': 'D001759', 'term': 'Blastomycosis'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D000386', 'term': 'AIDS-Related Complex'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'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': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D003881', 'term': 'Dermatomycoses'}, {'id': 'D008172', 'term': 'Lung Diseases, Fungal'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}, {'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': 'D010879', 'term': 'Piperazines'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1997-12', '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': ['Itraconazole', 'Histoplasmosis', 'Antifungal Agents', 'Acquired Immunodeficiency Syndrome', 'Amphotericin B', 'AIDS-Related Complex', 'Blastomycosis', 'Antibiotics, Antifungal'], 'conditions': ['HIV Infections', 'Histoplasmosis', 'Blastomycosis']}, 'descriptionModule': {'briefSummary': 'To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis.', 'detailedDescription': 'Patients are randomized to receive IV itraconazole for 2 days, then either itraconazole daily for 5 days or amphotericin B daily for 7 days. IV treatment is followed by consolidation with oral itraconazole for up to 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients must have:\n\n* HIV positive or negative status.\n* Blastomycosis or histoplasmosis.\n* Life expectancy of at least 1 week.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Liver disease.\n* Self-limiting fungal disease.\n* Very severe fungal disease such as meningeal involvement.\n* Acute respiratory disease.\n\nConcurrent Medication:\n\nExcluded at any time:\n\n* Terfenadine.\n* Astemizole.\n* Oral midazolam.\n* Triazolam.\n* Cisapride.\n* Phenytoin.\n* Phenobarbital.\n* Rifampin.\n* Rifabutin.\n\nExcluded during oral consolidation:\n\n* H2 blockers.\n* Chronic antacids.\n* Omeprazole.\n* Lansoprazole.\n\nPatients with the following prior condition are excluded:\n\nHypersensitivity to azole antifungals.\n\nPrior Medication:\n\nExcluded at any time:\n\nMore than 3 days of amphotericin B, fluconazole, or ketoconazole.\n\nExcluded within 2 weeks prior to study entry:\n\n* Phenytoin.\n* Phenobarbital.\n* Rifampin.\n* Rifabutin.'}, 'identificationModule': {'nctId': 'NCT00002159', 'briefTitle': 'A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis', 'orgStudyIdInfo': {'id': '254A'}, 'secondaryIdInfos': [{'id': 'ITR-USA-118'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Itraconazole', 'type': 'DRUG'}, {'name': 'Amphotericin B', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Station / Infectious Division', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Univ of Arkansas for Med Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Division of Infectious Diseases', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Division of Inf Diseases/ Indiana Univ Hosp', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46218', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Hosp', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '71130', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU Med Ctr / Div of Pulmonary & Critical Care Med', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'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': '641082792', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Univ of Missouri / Division of Infectious Diseases', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Infectious Diseases Association / Research Med Ctr', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen, LP', 'class': 'INDUSTRY'}}}}