Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2025-12-27 @ 9:14 PM
Study NCT ID:
NCT00192595
Status:
COMPLETED
Last Update Posted:
2015-04-01
First Post:
2005-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tenofovir in HIV/HBV Coinfection
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D015215', 'term': 'Zidovudine'}, {'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'C050016', 'term': 'lipoarabinomannan'}, {'id': 'C098320', 'term': 'efavirenz'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-30', 'studyFirstSubmitDate': '2005-09-11', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare HBV DNA suppression to levels below the limit of detection (<400 copies/ml) by week 48 in each group'}], 'secondaryOutcomes': [{'measure': '-HBV resistance at 48 weeks; -undetectable HBV DNA at weeks 12 & 24; -HBeAg and HBsAg seroconversion at weeks 24 & 48; -ALT chnages and rate of hepatic cytolysis; -HIV-1 RNA supression and CD4/CD8 changes over 48 weeks;'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatitis B', 'HIV', 'Treatment Naive'], 'conditions': ['HIV Infection', 'Hepatitis B Coinfection']}, 'referencesModule': {'references': [{'pmid': '22405335', 'type': 'DERIVED', 'citation': 'Avihingsanon A, Matthews GV, Lewin SR, Marks P, Sasadeusz J, Cooper DA, Bowden S, Locarnini S, Dore GJ, Ruxrungtham K. Assessment of HBV flare in a randomized clinical trial in HIV/HBV coinfected subjects initiating HBV-active antiretroviral therapy in Thailand. AIDS Res Ther. 2012 Mar 9;9(1):6. doi: 10.1186/1742-6405-9-6.'}, {'pmid': '18697216', 'type': 'DERIVED', 'citation': 'Matthews GV, Avihingsanon A, Lewin SR, Amin J, Rerknimitr R, Petcharapirat P, Marks P, Sasadeusz J, Cooper DA, Bowden S, Locarnini S, Ruxrungtham K, Dore GJ. A randomized trial of combination hepatitis B therapy in HIV/HBV coinfected antiretroviral naive individuals in Thailand. Hepatology. 2008 Oct;48(4):1062-9. doi: 10.1002/hep.22462.'}], 'seeAlsoLinks': [{'url': 'http://www.med.unsw.edu.au/nchecr', 'label': 'National Centre in HIV Epidemiology and Clinical Research'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the effectiveness of 3 different treatment regimens in reducing or clearing the Hepatitis B Virus in patients infected with HIV and Hepatitis B (co-infection)', 'detailedDescription': 'A randomised multi-centre trial of tenofovir vs lamivudine vs tenofovir/lamivudine in antiretroviral naïve subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A). Plus, a 12 week viral kinetic sub-study comparing a sub-group of the patients on Clinical Trial A with a group of therapy naïve HBV mono-infected subjects (Substudy A1)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent\n* Documented HIV infection (positive serology for HIV-1 and detectable HIV-1 RNA)\n* Age 18 - 70 years\n* HBV DNA \\> 105 copies/ml\n* HBsAg positive \\>6 months or HBsAg positive and anti HB core IgM negative\n* Creatinine \\<= 2.0mg/dl (\\<= 0.2 mmol/L)\n* Platelet count \\>= 50,000/mm\n* HIV-1 antiretroviral therapy naïve\n* No prior exposure to anti-HBV agents (LAM, adefovir, TDF) although prior IFN treatment allowed\n\nExclusion Criteria:\n\n* HCV-RNA positive or Anti-HAV IgM positive\n* Acute hepatitis (serum ALT \\> 1000 U/L)\n* Active opportunistic infection\n* Other causes of chronic liver disease identified (autoimmune hepatitis, hemochromatosis, Wilsons disease, alfa-1-antitrypsin deficiency)\n* Concurrent malignancy requiring cytotoxic chemotherapy\n* Decompensated or Child's C cirrhosis\n* Alfa-fetoprotein (AFP) \\> 3X ULN (unless negative CT scan or MRI within 3 months of entry date)\n* Pregnancy or lactation\n* Any other condition which in the opinion of the investigator might interfere with compliance or outcome of the study"}, 'identificationModule': {'nctId': 'NCT00192595', 'acronym': 'TICO', 'briefTitle': 'Tenofovir in HIV/HBV Coinfection', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kirby Institute'}, 'officialTitle': 'Virological and Clinical Anti-HBV Efficacy of Tenofovir in Antiretroviral naïve Patients With HIV/HBV Co-infection', 'orgStudyIdInfo': {'id': 'VHWG001'}, 'secondaryIdInfos': [{'id': 'TICO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1:', 'description': 'Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)', 'interventionNames': ['Drug: Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Zidovudine (AZT), tenofovir (TDF), efavirenz (EFV)', 'interventionNames': ['Drug: Tenofovir']}, {'type': 'EXPERIMENTAL', 'label': 'Amr 3', 'description': 'Lamivudine (LAM), tenofovir (TDF), efavirenz (EFV)', 'interventionNames': ['Drug: Tenofovir']}], 'interventions': [{'name': 'Tenofovir', 'type': 'DRUG', 'armGroupLabels': ['Amr 3', 'Arm 2']}, {'name': 'Zidovudine (AZT), lamivudine (LAM), efavirenz (EFV)', 'type': 'DRUG', 'armGroupLabels': ['Arm 1:']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Thai Red Cross AIDS Research Centre', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Greg Dore, MBBS, FRACP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Centre in HIV Epidemiology and Clinical Research.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirby Institute', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'The University of New South Wales', 'class': 'OTHER'}, {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'A/Prof Gregory J Dore', 'oldOrganization': 'National Centre in HIV Epidemiology and Clinical Research, Univeristy of New South Wales'}}}}