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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00158535
• Other study ID #: ANRS HC08 THEVIC
• Status: Terminated
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: September 9, 2005
• Start date: June 2002

Study information

• Verified date: September 2005
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• liver transplantation

Locations

Country	Name	City	State
France	Centre hepato biliaire hopital paul Brousse	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of liver transplantation in patients with HCV-HIV coinfection: survival at one and two years.
Secondary	Graft survival
Secondary	Unexpected infections or neoplasia
Secondary	Toxicity of antiretroviral and immunosuppressive treatments
Secondary	Replicative kinetics of HIV and HVC after transplantation in blood and liver
Secondary	Immune status of HIV and HVC
Secondary	Quality of life