Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT00158535
Status:
TERMINATED
Last Update Posted:
2005-09-12
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006526', 'term': 'Hepatitis C'}], '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': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016031', 'term': 'Liver Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 15}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'lastUpdateSubmitDate': '2005-09-09', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of liver transplantation in patients with HCV-HIV coinfection: survival at one and two years.'}], 'secondaryOutcomes': [{'measure': 'Graft survival'}, {'measure': 'Unexpected infections or neoplasia'}, {'measure': 'Toxicity of antiretroviral and immunosuppressive treatments'}, {'measure': 'Replicative kinetics of HIV and HVC after transplantation in blood and liver'}, {'measure': 'Immune status of HIV and HVC'}, {'measure': 'Quality of life'}]}, 'conditionsModule': {'keywords': ['Liver Transplantation', 'Hepatitis C', 'HIV Infections'], 'conditions': ['HIV Infections', 'Hepatitis C']}, 'descriptionModule': {'briefSummary': 'To show the feasibility of liver transplantation in HCV-HIV coinfected patients. To study the two-year survival after transplantation, the interaction between HCV and HIV after transplantation, the influence of HIV on HCV recurrence after transplantation, the interaction between immunosuppressive and antiretroviral drugs in particular anti-proteases, immunological follow-up and quality of life of these patients', 'detailedDescription': 'Until recently, HIV infection was considered as a contraindication for liver transplantation. A dramatic improvement in survival of HIV patients have been observed since the advent of new antiviral treatments against HIV including antiproteases. However an important proportion of patients with HCV-HIV coinfection are suffering from life-threatening liver disease due to HCV infection. Liver transplantation may be considered in this particular group of patients.\n\nThe ideal timing for the indication of liver transplantation during HIV disease and during the course of HCV liver disease needs to be defined. Liver transplantation in this particular group of patients raised several questions : a) the role of HIV infection on prevalence and severity of HCV recurrence after transplantation ; b) the role of liver transplantation and immunosuppression on HIV disease ; c) drug interactions between immunosuppressive agents and antiproteases ; d) immunological follow-up and quality of life of these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coinfection HIV-HVC\n* Indication of liver transplantation for severe hepatopathy with life threatening:repetitive ascitis or infection of ascitis or icterus or decreased of prothrombin index under 50 percent or digestive haemorrhage by portal hypertension uncontrolled\n\nExclusion Criteria:\n\n* Toxicomania\n* Alcohol consumer (over 30g per day)\n* AgHBs positive\n* hepatocarcinoma over 5 cm or 3 nodules\n* CD4 below 200/mm3\n* Viral load below 400 cp\n* HIV stade C'}, 'identificationModule': {'nctId': 'NCT00158535', 'briefTitle': 'Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection', 'organization': {'class': 'OTHER_GOV', 'fullName': 'French National Agency for Research on AIDS and Viral Hepatitis'}, 'officialTitle': 'Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection ANRS HC08 Thevic', 'orgStudyIdInfo': {'id': 'ANRS HC08 THEVIC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'liver transplantation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94804 cedex', 'city': 'Villejuif', 'country': 'France', 'facility': 'Centre hepato biliaire hopital paul Brousse', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Didier Samuel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Paul Brousse Villejuif France'}, {'name': 'Bruno Fallisard, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Unité de Santé Publique, Hôpital Paul Brousse, Villejuif France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French National Agency for Research on AIDS and Viral Hepatitis', 'class': 'OTHER_GOV'}}}}