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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Brief Summary

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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

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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.

Conditions

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HIV Infections Hepatitis C

Keywords

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Liver Transplantation Hepatitis C HIV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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liver transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Didier Samuel, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Paul Brousse Villejuif France

Bruno Fallisard, MD

Role: STUDY_CHAIR

Unité de Santé Publique, Hôpital Paul Brousse, Villejuif France

Locations

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Centre hepato biliaire hopital paul Brousse

Villejuif, , France

Site Status

Countries

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France

Other Identifiers

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ANRS HC08 THEVIC

Identifier Type: -

Identifier Source: org_study_id