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

Phase 2
18 Years
69 Years
Not Enrolling
HIV Infections, Hepatitis C

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Trial Information

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

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.

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Didier Samuel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hopital Paul Brousse Villejuif France


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

June 2002

Completion Date:

Related Keywords:

  • HIV Infections
  • Hepatitis C
  • Liver Transplantation
  • Hepatitis C
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Hepatitis
  • Hepatitis A
  • Hepatitis C
  • Immunologic Deficiency Syndromes