Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-11 @ 9:14 PM
Study NCT ID:
NCT06421259
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Descriptive Analysis of Changes in Hepatitis B Markers in People Living With HIV on Injectable Therapy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006509', 'term': 'Hepatitis B'}], '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': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2024-05-13', 'studyFirstSubmitQcDate': '2024-05-15', 'lastUpdatePostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of HBV reactivation under injectable HIV ART', 'timeFrame': 'From start of injectable HIV treatment to hepatitis B reactivation, assessed up to 24 months', 'description': 'HBV serology, DNA HBV levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hiv Infection', 'Hepatitis B']}, 'descriptionModule': {'briefSummary': 'In order to assess the risk of hepatitis B reactivation in people living with HIV and undergoing injection therapy, we propose to carry out a descriptive analysis of the evolution of hepatitis B markers in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV infected patients attending care in the infectiious disease department of the Universitary Hospital of Nice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-HIV infected patients under injectable ART\n\nExclusion Criteria:\n\n-Active HBV infection'}, 'identificationModule': {'nctId': 'NCT06421259', 'briefTitle': 'Descriptive Analysis of Changes in Hepatitis B Markers in People Living With HIV on Injectable Therapy.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'To Switch or Not to Switch to CAB/RPV in PLWH With Past HBV Infection? Risk of HBV Reactivation? A Need for New HBV Markers?', 'orgStudyIdInfo': {'id': '24Infectio01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV infected patients under injectable ART', 'description': 'HIV infected patients under injectable ART'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0600', 'city': 'Nice', 'state': 'Alpes Maritimes', 'country': 'France', 'contacts': [{'name': 'naqvi.a@chu-nice.fr NAQVI', 'role': 'CONTACT', 'email': 'naqvi.a@chu-nice.fr', 'phone': '0492035468', 'phoneExt': '+33'}, {'name': 'Alissa NAQVI', 'role': 'CONTACT', 'email': 'naqvi.a@chu-nice.fr', 'phone': '0492035468', 'phoneExt': '+33'}], 'facility': 'CHU NiICE', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Alissa NAQVI', 'role': 'CONTACT', 'email': 'naqvi.a@chu-nice.fr', 'phone': '492035468', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Alissa NAQVI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}