Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
Study NCT ID:
NCT00158535
Status:
TERMINATED
Last Update Posted:
2005-09-12
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
Study Overview
Official Title:
Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection ANRS HC08 Thevic
Status:
TERMINATED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: