Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

Official Title
-----------------
Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection ANRS HC08 Thevic

Conditions
-----------------
HIV Infections, Hepatitis C

Intervention / Treatment
-----------------
* Procedure: liver transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coinfection HIV-HVC 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 Exclusion Criteria: Toxicomania Alcohol consumer (over 30g per day) AgHBs positive hepatocarcinoma over 5 cm or 3 nodules CD4 below 200/mm3 Viral load below 400 cp HIV stade C

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: liver transplantation|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of liver transplantation in patients with HCV-HIV coinfection: survival at one and two years. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver Transplantation, Hepatitis C, HIV Infections