Clinical trial NCT00158535: Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection
Official title: Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection ANRS HC08 Thevic
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: HIV Infections
Hepatitis C
Keywords: Liver Transplantation
Hepatitis C
HIV Infections
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
First posted: 2005-09-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility of liver transplantation in patients with HCV-HIV coinfection: survival at one and two years.
Secondary outcomes:
measure: Graft survival
measure: Unexpected infections or neoplasia
measure: Toxicity of antiretroviral and immunosuppressive treatments
measure: Replicative kinetics of HIV and HVC after transplantation in blood and liver
measure: Immune status of HIV and HVC
measure: Quality of life
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Centre hepato biliaire hopital paul Brousse
Study officials:
affiliation: Hopital Paul Brousse Villejuif France
name: Didier Samuel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unité de Santé Publique, Hôpital Paul Brousse, Villejuif France
name: Bruno Fallisard, MD
role: STUDY_CHAIR
References: