Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection ANRS HC08 Thevic
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Feasibility of liver transplantation in patients with HCV-HIV coinfection: survival at one and two years.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Feasibility of liver transplantation in patients with HCV-HIV coinfection: survival at one and two years.
Secondary Outcomes
- 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