NCT00158535

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

September 12, 2005

Status Verified

September 1, 2005

First QC Date

September 9, 2005

Last Update Submit

September 9, 2005

Conditions

HIV InfectionsHepatitis C

Keywords

Liver TransplantationHepatitis CHIV Infections

Outcome Measures

Primary Outcomes (1)

  • Feasibility of liver transplantation in patients with HCV-HIV coinfection: survival at one and two years.

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Interventions

liver transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hepato biliaire hopital paul Brousse

Villejuif, 94804 cedex, France

Location

MeSH Terms

Conditions

HIV InfectionsHepatitis C

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDigestive System Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Study Officials

  • Didier Samuel, MD

    Hopital Paul Brousse Villejuif France

    PRINCIPAL INVESTIGATOR

  • Bruno Fallisard, MD

    Unité de Santé Publique, Hôpital Paul Brousse, Villejuif France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

June 1, 2002

Last Updated

September 12, 2005

Record last verified: 2005-09

Locations

FR(1)