Trials / Terminated
TerminatedNCT00158535
Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection
Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection ANRS HC08 Thevic
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (planned)
- Sponsor
- French National Agency for Research on AIDS and Viral Hepatitis · Other Government
- Sex
- All
- Age
- 18 Years – 69 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | liver transplantation |
Timeline
- Start date
- 2002-06-01
- First posted
- 2005-09-12
- Last updated
- 2005-09-12
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00158535. Inclusion in this directory is not an endorsement.