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

Primary Purpose

HIV Infections, Hepatitis C

Status

Terminated

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

liver transplantation

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Liver Transplantation, Hepatitis C, HIV Infections

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre hepato biliaire hopital paul Brousse

Outcomes

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

Full Information

NCT ID

NCT00158535

First Posted

September 9, 2005

Last Updated

September 9, 2005

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

1. Study Identification

Unique Protocol Identification Number

NCT00158535

Brief Title

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

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Terminated

Study Start Date

June 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, Hepatitis C

Keywords

Liver Transplantation, Hepatitis C, HIV Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

liver transplantation

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Graft survival

Title

Unexpected infections or neoplasia

Title

Toxicity of antiretroviral and immunosuppressive treatments

Title

Replicative kinetics of HIV and HVC after transplantation in blood and liver

Title

Immune status of HIV and HVC

Title

Quality of life

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Didier Samuel, MD

Organizational Affiliation

Hopital Paul Brousse Villejuif France

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bruno Fallisard, MD

Organizational Affiliation

Unité de Santé Publique, Hôpital Paul Brousse, Villejuif France

Official's Role

Study Chair

Facility Information:

Facility Name

Centre hepato biliaire hopital paul Brousse

City

Villejuif

ZIP/Postal Code

94804 cedex

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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