Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-29 @ 4:56 PM
Study NCT ID:
NCT00662194
Status:
UNKNOWN
Last Update Posted:
2014-03-10
First Post:
2008-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D060085', 'term': 'Coinfection'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-06', 'studyFirstSubmitDate': '2008-04-17', 'studyFirstSubmitQcDate': '2008-04-18', 'lastUpdatePostDateStruct': {'date': '2014-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TLR change with HIV co-infection therapy', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'TLR change patterns on spontaneously and on treatment resolved HBV or HCV in the co-infected setting', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'HBV', 'HCV', 'co-infection', 'innate immunity'], 'conditions': ['HIV-hepatitis Co-infection', 'HIV Infections']}, 'descriptionModule': {'briefSummary': 'Data from this study will provide the first information how the innate immune system may be altered in HIV-HCV and HIV-HBV co-infected individuals, and describe Toll-like receptor changes with HIV co-infection therapy.', 'detailedDescription': 'It has been demonstrated that Toll-like receptors (TLR) are involved in viral hepatitis - hepatitis B (HBV), hepatitis C (HCV) - and HIV in the setting of mono-infection. However the role of innate immunity in the pathogenesis of HIV-hepatitis co-infection in both natural and therapy-associated viral clearance remains unclear. The data from this study may reveal patterns which could predict how and when patients spontaneously, and with therapy, resolve HBV or HCV in the setting of co-infection.\n\nThe aim of the study is to evaluate the activity of innate immunity in different subsets of HIV-infected populations co-infected with chronic hepatitis B and/or C. Our hypothesis is that innate immunity is altered in HIV and hepatitis co-infection and that this differs from both hepatitis and HIV mono-infection.\n\nThe study is a cross-sectional and longitudinal pilot study of individuals infected with HIV and either HBV or HCV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinics', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV and either HBV or HCV co-infection\n* 18 years and older\n* able to give informed consent\n\nExclusion Criteria:\n\n* HIV-HBV-HCV triple infection'}, 'identificationModule': {'nctId': 'NCT00662194', 'briefTitle': 'Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bayside Health'}, 'officialTitle': 'A Study of Innate Immunity in HIV Positive Patients Co-infected With Hepatitis C or Hepatitis B', 'orgStudyIdInfo': {'id': 'ALF-55/08'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'HIV-HBV co-infected and receiving anti-retroviral therapy (ART) and CD4 count \\> 500cells/mm3'}, {'label': '2', 'description': 'HIV-HBV co-infected and receiving ART and CD4 count 200-500 cells/mm3'}, {'label': '3', 'description': 'HIV-HBV co-infected and receiving ART and CD4 count \\<200cells/mm3'}, {'label': '4', 'description': 'HIV-HBV co-infected and not receiving ART'}, {'label': '5', 'description': 'HIV-HCV co-infected \\& receiving anti-retroviral therapy (ART) and CD4 count \\> 500cells/mm3'}, {'label': '6', 'description': 'HIV-HCV co-infected and receiving ART and CD4 count 200-500 cells/mm3'}, {'label': '7', 'description': 'HIV-HCV co-infected and receiving ART and CD4 count \\<200cells/mm3'}, {'label': '8', 'description': 'HIV-HCV co-infected and not receiving ART'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Jennifer Audsley, PhD', 'role': 'CONTACT', 'email': 'jennifer.audsley@med.monash.edu.au', 'phone': '+613 99030184'}, {'name': 'David Iser, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Joe Sasadeusz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Jennifer Audsley, PhD', 'role': 'CONTACT', 'email': 'jennifer.audsley@med.monash.edu.au', 'phone': '+613 99030184'}], 'overallOfficials': [{'name': 'Joe Sasadeusz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Alfred'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayside Health', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Monash Medical Centre', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}