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Raltegravir in Patients With End Stage Liver Disease and in Transplant Recipients

NCT01022476 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-04-06

No results posted yet for this study

Summary

This phase I/II, multi-center study is designed to determine the pharmacokinetic profile of Raltegravir in patients with end stage liver disease and to assess drug-drug interaction when Raltegravir is combined with immunosuppressive therapy in liver transplant recipients.

Conditions

  • HIV Infection
  • Liver Failure
  • Evidence of Liver Transplantation

Interventions

DRUG

Raltegravir potassium

one pill of raltegravir 400 mg twice a day

Sponsors & Collaborators

Principal Investigators

  • Elina TEICHER, MD · Hôpital de Bicêtre - LE KREMLIN-BICETRE - FRANCE

  • Jean-Pierre ABOULKER, MD · INSERM SC10 VILLEJUIF FRANCE

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01022476 on ClinicalTrials.gov