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
  Purpose

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


Condition Intervention Phase
HIV Infections
Hepatitis C
Procedure: liver transplantation
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • Feasibility of liver transplantation in patients with HCV-HIV coinfection: survival at one and two years.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 15
Study Start Date: June 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158535

Locations
France
Centre hepato biliaire hopital paul Brousse
Villejuif, France, 94804 cedex
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
Principal Investigator: Didier Samuel, MD Hopital Paul Brousse Villejuif France
Study Chair: Bruno Fallisard, MD Unité de Santé Publique, Hôpital Paul Brousse, Villejuif France
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00158535     History of Changes
Other Study ID Numbers: ANRS HC08 THEVIC
Study First Received: September 9, 2005
Last Updated: September 9, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
Liver Transplantation
Hepatitis C
HIV Infections

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis A
Hepatitis C
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 23, 2014