Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-30 @ 11:53 AM
Study NCT ID:
NCT00002133
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002180', 'term': 'Candidiasis, Oral'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D000386', 'term': 'AIDS-Related Complex'}], 'ancestors': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic 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': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1996-04', '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', 'Acquired Immunodeficiency Syndrome', 'AIDS-Related Complex', 'Candidiasis, Oral'], 'conditions': ['Candidiasis, Oral', 'HIV Infections']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Moskovitz B, Wu J, Baruch A, Benken C. Long term safety and efficacy of itraconazole oral solution (IS) for treatment of fluconazole refractory oropharyngeal candidiasis (OC) in HIV-positive patients (pts). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:124 (abstract no 325)'}]}, 'descriptionModule': {'briefSummary': 'To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.', 'detailedDescription': 'Patients receive itraconazole oral solution twice daily. Per 08/15/94 amendment, patients with complete resolution of oropharyngeal candidiasis lesions upon completion of treatment are eligible for maintenance treatment on protocol FDA 236C. Patients who decline maintenance are followed for 6 weeks. Patients who relapse during follow-up are re-treated for 14-28 days; if lesions clear, patients may enter the maintenance protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nPatients must have:\n\n* HIV antibody seropositivity or diagnosis of AIDS.\n* Confirmed oropharyngeal candidiasis.\n* Failed fluconazole treatment within the past 14 days.\n* Life expectancy of at least 3 months.\n* NO symptoms of esophageal candidiasis (e.g., dysphagia) unless endoscopic exam of esophagus was performed and fungal esophagitis was not present.\n* NO prior disseminated candidiasis.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Underlying clinical condition that precludes study completion or places the patient at significant risk.\n* Considered unreliable about following physician's directives.\n\nConcurrent Medication:\n\nExcluded:\n\n* Investigational drugs (approved expanded access drugs are permitted).\n* Rifampin.\n* Rifabutin.\n* Phenobarbital.\n* Phenytoin.\n* Carbamazepine.\n* Terfenadine.\n* Astemizole.\n\nPatients with the following prior conditions are excluded:\n\n* History of hypersensitivity to imidazole or azole compounds.\n* Clinical evidence of significant hepatic disease within the past 2 months.\n\nPrior Medication:\n\nExcluded:\n\n* Investigational drugs within 1 month prior to study entry (approved expanded access drugs are permitted)."}, 'identificationModule': {'nctId': 'NCT00002133', 'briefTitle': 'An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.', 'orgStudyIdInfo': {'id': '236B'}, 'secondaryIdInfos': [{'id': 'ITR-USA-94'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Itraconazole', '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': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Univ of Arkansas for Med Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'East Bay AIDS Ctr', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Med Ctr', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Dr Douglas Ward', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'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': '20422', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Veterans Administration Med Ctr', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Infectious Diseases Research Clinic / Indiana Univ Hosp', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Natl Inst of Allergy & Infect Dis / Cln Ctr', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'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': 'Wayne State Univ / Harper Hosp', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington Univ', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State Univ Hosp', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma City Veterans Administration Med Ctr', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania Hosp', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Infectious Disease Clinic', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78284', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Audie L Murphy Veterans Administration Hosp', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Univ of Virginia Health Sciences Ctr', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen, LP', 'class': 'INDUSTRY'}}}}