Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-05 @ 10:32 PM
Study NCT ID:
NCT02889094
Status:
UNKNOWN
Last Update Posted:
2018-04-26
First Post:
2016-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French HIV-HBV Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D058625', 'term': 'End Stage Liver Disease'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum and plasma samples will be stored for quantification of biochemical parameters.\n\nLiver tissue (for individuals receiving liver biopsies) will be stored for quantification of intracellular HBV DNA replication.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-25', 'studyFirstSubmitDate': '2016-08-25', 'studyFirstSubmitQcDate': '2016-09-02', 'lastUpdatePostDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HBV DNA replication', 'timeFrame': '14 years', 'description': 'Proportion of patients with detectable HBV DNA levels, as determined by a commercially-available PCR assay (\\>60 international units/mL), at the beginning and end of follow-up'}, {'measure': 'HBeAg-seroclearance', 'timeFrame': '14 years', 'description': 'Proportion of hepatitis B "e" antigen (HBeAg)-positive patients who lose HBeAg-positive serology, as determined by a commercially-available ELISA assay, by the end of follow-up'}, {'measure': 'HBsAg-seroclearance', 'timeFrame': '14 years', 'description': 'Proportion of patients who lose hepatitis B surface antigen (HBsAg)-positive serology, as determined by a commercially-available ELISA assay, by the end of follow-up'}, {'measure': 'Liver fibrosis (FibroTest)', 'timeFrame': '14 years', 'description': 'Proportion of patients with equivalent F3 or F4 liver fibrosis, as determined by the FibroTest (non-invasive biochemical score) with a level \\>= 0.59, at the beginning and end of follow-up'}, {'measure': 'Liver fibrosis (FibroScan)', 'timeFrame': '14 years', 'description': 'Proportion of patients with equivalent F3 or F4 liver fibrosis, as determined by the FibroScan (transient elastography) with a level \\>= 7.6 kPa, at the beginning and end of follow-up'}], 'secondaryOutcomes': [{'measure': 'Liver-related morbidity', 'timeFrame': '14 years', 'description': 'Proportion of patients exhibiting any causes of morbidity related to liver-specific disease by the end of follow-up'}, {'measure': 'Liver-related mortality', 'timeFrame': '14 years', 'description': 'Proportion of patients who died due to liver-specific disease by the end of follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hepatitis B', 'HIV', 'Liver Cirrhosis', 'End Stage Liver Disease']}, 'referencesModule': {'references': [{'pmid': '26153669', 'type': 'BACKGROUND', 'citation': "Boyd A, Gozlan J, Miailhes P, Lascoux-Combe C, Cam MS, Rougier H, Zoulim F, Girard PM, Lacombe K. Rates and determinants of hepatitis B 'e' antigen and hepatitis B surface antigen seroclearance during long-term follow-up of patients coinfected with HIV and hepatitis B virus. AIDS. 2015 Sep 24;29(15):1963-73. doi: 10.1097/QAD.0000000000000795."}, {'pmid': '24752996', 'type': 'BACKGROUND', 'citation': 'Boyd A, Gozlan J, Maylin S, Delaugerre C, Peytavin G, Girard PM, Zoulim F, Lacombe K. Persistent viremia in human immunodeficiency virus/hepatitis B coinfected patients undergoing long-term tenofovir: virological and clinical implications. Hepatology. 2014 Aug;60(2):497-507. doi: 10.1002/hep.27182. Epub 2014 Jun 20.'}, {'pmid': '16439876', 'type': 'BACKGROUND', 'citation': 'Lacombe K, Massari V, Girard PM, Serfaty L, Gozlan J, Pialoux G, Mialhes P, Molina JM, Lascoux-Combe C, Wendum D, Carrat F, Zoulim F. Major role of hepatitis B genotypes in liver fibrosis during coinfection with HIV. AIDS. 2006 Feb 14;20(3):419-27. doi: 10.1097/01.aids.0000200537.86984.0e.'}]}, 'descriptionModule': {'briefSummary': 'The overarching purpose of this study is to further understand the reasons for and clinical implications of persistent HBV infection in patients co-infected with HIV and HBV in the era of highly effective antiviral treatment against both viruses.', 'detailedDescription': 'The French HIV-HBV Cohort is an observational, non-interventional study including 308 HIV-infected patients with chronic HBV infection (HBsAg-positive serology \\>6 months) in seven clinical centers. Patients were recruited in 2002-2003 and followed prospectively every three to twelve months, during two phases, until 2010-2011. Extensive information on a variety of HIV- and HBV-related parameters were collected during these study visits.\n\nThis particular study aims to extend follow-up of the French HIV-HBV Cohort using a different type of design. Patients who completed at least one study phase of the French HIV-HBV Cohort are selected for participation. Patients continuing follow-up at a participating clinical center are asked to undergo their routine clinical visit, during which time medical data from the years since last cohort visit until their routine visit are extracted. For those who died, information from the years since last cohort visit until death will be collected.\n\nThe primary objective for this cohort extension is to further understand the reasons for and clinical implications of persistent HBV infection in patients co-infected with HIV and HBV in the era of highly effective antiviral treatment against both viruses.\n\nThe following secondary objectives are as follows:\n\n* To establish the extent of persistent viremia (PV) of HBV, quantified either in serum or within the hepatocyte\n* To understand whether this persistence effects clinically-relevant serological outcomes (i.e. HBeAg and HBsAg seroclearance and seroconversion along with HBsAg quantification) after prolonged follow-up\n* To quantify the evolution of liver fibrosis using non-invasive methods and, in a small subset of patients, liver biopsies, while investigating the virological and immunological factors associated with its progression and regression\n* To describe the causes of liver-related and non-liver-related morbidity and mortality and the direct effect of persistent HBV DNA replication on these outcomes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV-infected patients with chronic hepatitis B.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HBsAg seropositivity for \\>6 months (at initial cohort inclusion)\n* HIV-positive serology confirmed with Western blot (at initial cohort inclusion)\n* Karnofsky score \\>70 (at initial cohort inclusion)\n* Age ≥18 years old (at initial cohort inclusion)\n* Completed follow-up in at least one previous study phase of the French HIV-HBV Cohort\n* Obtained signed written informed consent\n\nExclusion Criteria:\n\n* Refusal to participate\n* Any severe physical, clinical or mental condition preventing participation'}, 'identificationModule': {'nctId': 'NCT02889094', 'acronym': 'COVViB', 'briefTitle': 'French HIV-HBV Cohort', 'organization': {'class': 'OTHER', 'fullName': "Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba"}, 'officialTitle': 'Multi-center Study Evaluating Persistence of Hepatitis B Virus Replication, Long-term Prognostic Indicators and Their Clinical Relevance in Patients Co-infected With the Human Immunodeficiency Virus and Chronic Hepatitis B', 'orgStudyIdInfo': {'id': 'IMEA 49'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV-HBV co-infected individuals', 'description': 'No interventions will be administered. Individuals will be undergoing routine care.', 'interventionNames': ['Other: Routine care']}], 'interventions': [{'name': 'Routine care', 'type': 'OTHER', 'description': 'Routine care recommended for patients co-infected with HIV and hepatitis B virus (per European Association for the Study of the Liver and European AIDS Clinical Society guidelines).', 'armGroupLabels': ['HIV-HBV co-infected individuals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69317', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre hospitalier universitaire de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint-Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Anders Boyd, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'INSERM UMR S 1136'}, {'name': 'Karine Lacombe, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'INSERM UMR S 1136'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will only be made available upon official request, pending approval by the Scientific Committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba", 'class': 'OTHER'}, 'collaborators': [{'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, {'name': 'Sidaction', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}