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

Phase 2

Terminated

• Conditions: Hepatitis C; HIV Infections

• Registration Number: NCT00158535
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

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.

Study Timeline

• Study Start: 2002-06
• Status Verified: 2005-09
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Last Update Submitted: 2005-09-09
• Study First Posted: 2005-09-12
• Last Update Posted: 2005-09-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of liver transplantation in patients with HCV-HIV coinfection: survival at one and two years.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre hepato biliaire hopital paul Brousse; 🇫🇷 Villejuif, France