Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection ANRS HC08 Thevic|
- Feasibility of liver transplantation in patients with HCV-HIV coinfection: survival at one and two years.
- Graft survival
- Unexpected infections or neoplasia
- Toxicity of antiretroviral and immunosuppressive treatments
- Replicative kinetics of HIV and HVC after transplantation in blood and liver
- Immune status of HIV and HVC
- Quality of life
|Study Start Date:||June 2002|
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.
The 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158535
|Centre hepato biliaire hopital paul Brousse|
|Villejuif, France, 94804 cedex|
|Principal Investigator:||Didier Samuel, MD||Hopital Paul Brousse Villejuif France|
|Study Chair:||Bruno Fallisard, MD||Unité de Santé Publique, Hôpital Paul Brousse, Villejuif France|