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| Sponsor: | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection ANRS HC08 Thevic |
| Estimated Enrollment: | 15 |
| Study Start Date: | June 2002 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France | |
| Centre hepato biliaire hopital paul Brousse | |
| Villejuif, France, 94804 cedex | |
| 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
| ClinicalTrials.gov Identifier: | NCT00158535 History of Changes |
| Other Study ID Numbers: | ANRS HC08 THEVIC |
| Study First Received: | September 9, 2005 |
| Last Updated: | September 9, 2005 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Liver Transplantation Hepatitis C HIV Infections |
|
Acquired Immunodeficiency Syndrome HIV Infections Hepatitis Hepatitis A Hepatitis C Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections |
