Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
Study NCT ID:
NCT00168194
Status:
COMPLETED
Last Update Posted:
2012-01-20
First Post:
2005-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cellular Immune Responses to Hepatitis B Virus (HBV)- Longitudinal Follow up and Natural History
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D015658', 'term': 'HIV Infections'}], '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': '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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-19', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2012-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV'], 'conditions': ['Hepatitis B', 'HIV Infections']}, 'descriptionModule': {'briefSummary': "It remains unclear why some individuals are able to clear HBV from their bodies while in others HBV is a persistent infection. We plan to investigate this process by collecting blood and analysing how the patient's white blood cells respond to different pieces of the HBV virus. We will use new tools that can precisely tell us which component of the immune response may be different in individuals who are chronically infected with HBV and also in individuals who are also infected with HIV.\n\nThe primary aims are therefore:\n\n1. To characterize HBV-specific T cell responses in HBV chronic carriers, and identify novel immunogenic regions in both HLA-A2+ and non-HLA-A2+ individuals.\n2. To determine the effect of HIV infection on HBV-specific T-cell responses"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV and hepatitis B co-infection', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nThere are two groups of patients in this study. Group A mono-infected with Hepatitis B, and those with co-infection HBV/HIV.\n\nGroup A inclusion criteria: (also split into 6 recruiting groups)\n\n* Acute hepatitis B\n* Chronic hepatitis B, HBV DNA+ve , normal ALT , HBeAg +ve\n* Chronic hepatitis B, HBV DNA +ve , normal ALT, HBeAg -ve\n* Chronic hepatitis , HBV DNA +ve, increased ALT, no HBV treatment B, HBeAg +ve\n* Chronic hepatitis B, HBV DNA +ve , increased ALT, no HBV treatment B, HBeAg -ve\n* Chronic hepatitis B, undergoing 'flare' of hepatitis\n\nGroup B inclusion criteria:\n\n* To be HIV/HBV co-infected\n\nAll patients:\n\n* To be over 18 years\n\nExclusion Criteria:\n\n* Those who do not fit the inclusion criteria."}, 'identificationModule': {'nctId': 'NCT00168194', 'briefTitle': 'Cellular Immune Responses to Hepatitis B Virus (HBV)- Longitudinal Follow up and Natural History', 'organization': {'class': 'OTHER', 'fullName': 'The Alfred'}, 'officialTitle': 'Cellular Immune Responses to Hepatitis B Virus (HBV)- Longitudinal Follow up and Natural History', 'orgStudyIdInfo': {'id': '235/04'}}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital, Commercial Road', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Sharon Lewin, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Burnet Institute, Melbourne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Alfred', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Jennifer Hoy', 'investigatorFullName': 'Jennifer Hoy', 'investigatorAffiliation': 'The Alfred'}}}}