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

Sponsored by:	French National Agency for Research on AIDS and Viral Hepatitis
Information provided by:	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT00158535

Purpose

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

Condition	Intervention	Phase
HIV Infections Hepatitis C	Procedure: liver transplantation	Phase II

MedlinePlus related topics: AIDS Hepatitis Hepatitis C Liver Transplantation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection ANRS HC08 Thevic

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

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

Estimated Enrollment:	15
Study Start Date:	June 2002

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

Ages Eligible for Study:	18 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158535

Locations

France
Centre hepato biliaire hopital paul Brousse
Villejuif, France, 94804 cedex

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

Investigators

Principal Investigator:	Didier Samuel, MD	Hopital Paul Brousse Villejuif France
Study Chair:	Bruno Fallisard, MD	Unité de Santé Publique, Hôpital Paul Brousse, Villejuif France

More Information

No publications provided

Study ID Numbers:	ANRS HC08 THEVIC
Study First Received:	September 9, 2005
Last Updated:	September 9, 2005
ClinicalTrials.gov Identifier:	NCT00158535 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

Liver Transplantation
Hepatitis C
HIV Infections

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Sexually Transmitted Diseases, Viral
Digestive System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Hepatitis, Viral, Human
Hepatitis C
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Liver Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Flaviviridae Infections
Immune System Diseases
Acquired Immunodeficiency Syndrome
Hepatitis, Viral, Human
Infection

Immunologic Deficiency Syndromes
Hepatitis
Virus Diseases
Digestive System Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Hepatitis C
Retroviridae Infections

ClinicalTrials.gov processed this record on May 06, 2009