Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-29 @ 8:01 PM
Study NCT ID:
NCT00763295
Status:
COMPLETED
Last Update Posted:
2012-10-26
First Post:
2008-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055985', 'term': 'Latent Tuberculosis'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000085343', 'term': 'Latent Infection'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-25', 'studyFirstSubmitDate': '2008-09-28', 'studyFirstSubmitQcDate': '2008-09-28', 'lastUpdatePostDateStruct': {'date': '2012-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['latent tuberculosis', 'HIV', 'IFN-γ based assay'], 'conditions': ['Latent Tuberculosis', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'HIV infection highly increases the risk of progression of latent tuberculosis (TB) to active disease that therapy is recommended for all PPD-positive, HIV-infected patients, regardless of age. Sensitivity of the PPD testing is, however, dependent on a normal T cell function.\n\nTherefore, an accurate and reliable method for detection of latent tuberculosis in patients with HIV is urgently needed.\n\nThis prospective study will examine the utility of interferon-gamma (IFN-γ) based assay, T-SPOT.TB,for detection of TB in HIV-infected individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with HIV confirmed by standard methods', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* adult individuals with confirmed HIV infection\n\nExclusion Criteria:\n\n* Patients who are on INH treatment\n* Patients who have a positive PPD test within 1 year of study enrollment\n* Individuals with blistering or ulcerating skin disorder\n* Pregnant women\n* Patients who were given blood transfusion within 6 weeks prior to enrollment'}, 'identificationModule': {'nctId': 'NCT00763295', 'briefTitle': 'Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV?', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Is Tuberculin Skin Testing Effective in Screening for Latent Tuberculosis in Patients With HIV?', 'orgStudyIdInfo': {'id': '08-015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV infection', 'interventionNames': ['Other: T-Spot.TB test']}], 'interventions': [{'name': 'T-Spot.TB test', 'type': 'OTHER', 'description': 'diagnostic test', 'armGroupLabels': ['HIV infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10305', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Staten Island University Hospital', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jordan Glaser, MD', 'oldOrganization': 'Staten Island University Hospital'}}}}