Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-02 @ 7:13 AM
Study NCT ID:
NCT02513758
Status:
COMPLETED
Last Update Posted:
2016-03-23
First Post:
2015-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Penetration and Compartimentation of HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood, saliva, sperm and cervicovaginal secretions'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-22', 'studyFirstSubmitDate': '2015-07-30', 'studyFirstSubmitQcDate': '2015-07-31', 'lastUpdatePostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Viral tropism of HIV', 'timeFrame': 'Inclusion', 'description': 'number of HIV virus in sperm or cervical secretions.'}], 'secondaryOutcomes': [{'measure': 'Genetic polymorphism for HIV strains', 'timeFrame': 'Inclusion', 'description': 'With a sequencing method, it is possible to classify the different strains in groups, according to their polymorphism.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV patients', 'Genital HIV penetration'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': "Genital mucosa is the main way of HIV penetration. Many cells can be involved (epithelial cells, Langerhans cells) and antibodies may also play a critical role. The investigators' study aims to precise the role of each type of cells, the interaction cell-cell and cell-antibodies.", 'detailedDescription': 'At inclusion, men will have a two blood sampling tubes of 10 ml each, a saliva sample and a sample of sperm and women will have a two blood sampling tubes of 10 ml each, a saliva sample and a sampling cervicovaginal secretions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (\\> 18 year-old) HIV positive,\n* HIV-CV\\> 1000 cp/ml,\n\nExclusion Criteria:\n\n* children'}, 'identificationModule': {'nctId': 'NCT02513758', 'briefTitle': 'Penetration and Compartimentation of HIV', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Penetration and Compartimentation of HIV in Genital Mucosa', 'orgStudyIdInfo': {'id': '0201078'}, 'secondaryIdInfos': [{'id': 'DGS 2002/0521', 'type': 'OTHER', 'domain': 'Health general direction'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV patients', 'description': 'Men will have blood sampling tubes of 10 ml each, a saliva sample and a sample of sperm Women will have a two blood sampling tubes of 10 ml each, a saliva sample and a sampling cervicovaginal secretions', 'interventionNames': ['Other: sample']}], 'interventions': [{'name': 'sample', 'type': 'OTHER', 'description': 'Men will have blood sampling tubes of 10 ml each, a saliva sample and a sample of sperm Women will have a two blood sampling tubes of 10 ml each, a saliva sample and a sampling cervicovaginal secretions', 'armGroupLabels': ['HIV patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'LUCHT', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Frédéric LUCHT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}