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

This study has been terminated.
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00158535
First received: September 9, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 9, 2005
September 9, 2005
June 2002
Not Provided
Feasibility of liver transplantation in patients with HCV-HIV coinfection: survival at one and two years.
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection
Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection ANRS HC08 Thevic

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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Hepatitis C
Procedure: liver transplantation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
Not Provided
Not Provided

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
Both
18 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00158535
ANRS HC08 THEVIC
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
Not Provided
Principal Investigator: Didier Samuel, MD Hopital Paul Brousse Villejuif France
Study Chair: Bruno Fallisard, MD Unité de Santé Publique, Hôpital Paul Brousse, Villejuif France
French National Agency for Research on AIDS and Viral Hepatitis
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP