Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-02 @ 7:05 AM
Study NCT ID:
NCT00647205
Status:
COMPLETED
Last Update Posted:
2011-08-09
First Post:
2008-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of 2 Interferon γ Assays in the Diagnosis of Latent Tuberculosis in HIV-infected Patients.ANRS EP 40 QUANTI SPOT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D014376', 'term': 'Tuberculosis'}], '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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-08', 'studyFirstSubmitDate': '2008-03-26', 'studyFirstSubmitQcDate': '2008-03-26', 'lastUpdatePostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intradermal Tuberculin Tests QuantiFERON TB Gold In-Tube® T-SPOT.TB®', 'timeFrame': '48 to 72 hours after the injection'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Interferon, gamma', 'HIV Infections', 'Tuberculosis'], 'conditions': ['HIV Infections', 'Tuberculosis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to estimate the usefulness of QuantiFERON TB Gold In-Tube® and T-SPOT.TB® for the diagnosis of latent tuberculosis in HIV infected antiretroviral naive patients: 80 originated from low TB prevalence countries, without any active TB; 80 HIV infected antiretroviral naïve patients originated from high TB prevalence countries, without any active TB, 40 HIV infected patients with active TB and 40 HIV negative patients with active TB.', 'detailedDescription': 'The aim of this study is to estimate the usefulness of QuantiFERON TB Gold In-Tube and T-SPOT.TB for the diagnosis of latent tuberculosis in this population. Concordance between TST, QuantiFERON TB Gold and T-SPOT.TB will be assessed in patients with different risks of TB, in a transversal study. This study will include 240 patients during 2 years: 80 HIV infected antiretroviral naïve patients originated from low TB prevalence countries, without any active TB (40 patients with CD4 cell count \\> 350/mm3, 40 with CD4 \\< 350/mm3), 80 HIV infected antiretroviral naïve patients originated from high TB prevalence countries, without any active TB, 40 HIV infected patients with active TB and 40 HIV negative patients with active TB. TST and the 2 blood interferon gamma assay will be compared according to the level of risk. The improvement of latent TB diagnosis in HIV infected patients may lead to the initiation of TB prophylaxis and decrease the incidence of this life threatening disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sign an informed consent\n* to be adult\n* not to be pregnant\n* to have a clinical examination and a medical questionnaire\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00647205', 'briefTitle': 'Evaluation of 2 Interferon γ Assays in the Diagnosis of Latent Tuberculosis in HIV-infected Patients.ANRS EP 40 QUANTI SPOT', 'organization': {'class': 'OTHER_GOV', 'fullName': 'French National Agency for Research on AIDS and Viral Hepatitis'}, 'officialTitle': 'Evaluation of 2 Interferon γ Assays (QuantiFERON TB Gold In-Tube® and T-SPOT.TB®) in the Diagnosis of Latent Tuberculosis in HIV-infected Patients.ANRS EP 40 QUANTI SPOT', 'orgStudyIdInfo': {'id': 'ANRS EP 40 QUANTI SPOT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': '1', 'description': 'HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active TB with CD4 cell count \\> 350/mm3', 'interventionNames': ['Device: QuantiFERON TB Gold In-Tube', 'Device: T-SPOT.TB®']}, {'type': 'SHAM_COMPARATOR', 'label': '2', 'description': 'HIV infected antiretroviral naïve patients originated from low TB prevalence countries without any active T with CD4 \\< 350/mm3)', 'interventionNames': ['Device: QuantiFERON TB Gold In-Tube', 'Device: T-SPOT.TB®']}, {'type': 'SHAM_COMPARATOR', 'label': '3', 'description': 'HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 \\< 350/mm3)', 'interventionNames': ['Device: QuantiFERON TB Gold In-Tube', 'Device: T-SPOT.TB®']}, {'type': 'SHAM_COMPARATOR', 'label': '4', 'description': 'HIV infected antiretroviral naïve patients originated from high TB prevalence countries without any active TB with CD4 \\> 350/mm3)', 'interventionNames': ['Device: QuantiFERON TB Gold In-Tube', 'Device: T-SPOT.TB®']}, {'type': 'SHAM_COMPARATOR', 'label': '5', 'description': 'HIV infected patients with active TB', 'interventionNames': ['Device: QuantiFERON TB Gold In-Tube', 'Device: T-SPOT.TB®']}, {'type': 'SHAM_COMPARATOR', 'label': '6', 'description': 'HIV negative patients with active TB', 'interventionNames': ['Device: QuantiFERON TB Gold In-Tube', 'Device: T-SPOT.TB®']}], 'interventions': [{'name': 'QuantiFERON TB Gold In-Tube', 'type': 'DEVICE', 'armGroupLabels': ['1', '2', '3', '4', '5', '6']}, {'name': 'T-SPOT.TB®', 'type': 'DEVICE', 'armGroupLabels': ['1', '2', '3', '4', '5', '6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Service des Maladies Infectieuses B Hopital Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Daniel Bonnet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AP-HP Paris'}, {'name': 'France Mentre, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French National Agency for Research on AIDS and Viral Hepatitis', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Marcia Trumeau regulatory', 'oldOrganization': 'ANRS'}}}}