NCT01453192

Brief Summary

The aim of this study is to evaluate the incidence of acute renal graft rejection 6 months after transplantation in HIV-infected patients under three antiretroviral drugs regimen including Raltegravir.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2011

Typical duration for phase_3

Geographic Reach
1 country

14 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 17, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

April 13, 2026

Status Verified

July 1, 2016

Enrollment Period

3.9 years

First QC Date

October 3, 2011

Last Update Submit

April 9, 2026

Conditions

HIV-1 InfectionChronic Renal Insufficiency

Keywords

RaltegravirRenal transplantationHIV-1Acute renal graft rejection

Outcome Measures

Primary Outcomes (1)

  • Incidence of acute clinical renal graft rejection

    Incidence of acute clinical renal graft rejection defined by 20% increase of serum creatinine, associated to histological features (Banff classification) 6 months after renal transplantation

    6 months

Secondary Outcomes (10)

  • Incidence of acute clinical and subclinical renal graft rejection

    1 year

  • One year graft survival

    1 year

  • Patients' survival

    1 year

  • Phenotyping of lymphocytic infiltrates in case of acute rejection

    1 year

  • Incidence of AIDS defined diseases and severe morbidity diseases after renal transplantation

    1 year

  • +5 more secondary outcomes

Study Arms (1)

Raltegravir

EXPERIMENTAL

Raltegravir associated to an antiretroviral regimen without ritonavir boosted antiprotease

Drug: Raltegravir

Interventions

RaltegravirDRUG

Introduction of Raltegravir 2 days after renal transplantation within an antiretroviral regimen without ritonavir boosted antiprotease

Also known as: Isentress
Raltegravir

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Registration on the French national renal transplantation waiting list (Biomedicines Agency) for a living or cadaveric donor organ
  • HIV-1-infected patients treated by a three-drug ARV regimen
  • Immuno-virologic criteria at renal transplantation: undetectable viral load (\<50 copies/mL) and CD4 \>200/mm3 for at least three months on stable ARV
  • Age \>18 years and \<70 years
  • Effective contraception for women
  • Written informed consent
  • Patient with social security coverage

You may not qualify if:

  • Permanent:
  • Hepatic cirrhosis
  • Serious psychiatric illness history
  • EBV or HHV8 lymphoproliferation (lymphoma, systemic Kaposi's sarcoma or multifocal Castleman's disease)
  • History of PML
  • HTLV-1 seropositivity
  • Severe pulmonary or cardiovascular disease with poor short-term vital prognosis
  • Patient with AgHBs+
  • History of cryptosporidiosis
  • History of fungal infection with multi resistant fungi not likely to respond to oral antifungal therapy
  • Impossibility or refusal of Raltegravir switch, decision made by doctor or patient
  • Temporary:
  • Recent malignancy (between 2 and 5 years according to type)
  • HPV-related cervical or anal disease: carcinoma in situ, AIN III, CIN III in remission for less than three years
  • Active infection
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Hôpital Pellegrin, Service de Nephrologie, Transplantation Rénale, Dialyse

Bordeaux, 33076, France

Location

CHU De Caen, Service de Néphrologie Hémodialyse

Caen, 14033, France

Location

Hôpital Henri Mondor, Service de Néphrologie Transplantation

Créteil, 94010, France

Location

Hôpital Kremlin Bicêtre, Service de Néphrologie

Le Kremlin-Bicêtre, 94275, France

Location

CHRU Lille, Service de néphrologie

Lille, 59037, France

Location

CHU de Nantes, Service de Néphrologie et Immunologie Clinique

Nantes, 44093, France

Location

Hôpital Pasteur, Service de Néphrologie - Transplantation

Nice, 06002, France

Location

Hopital Saint Louis, Service de Néphrologie

Paris, 75010, France

Location

Hôpital Necker, Service de Néphrologie adulte

Paris, 75743, France

Location

Hôpital TENON, Urgences Néphrologiques et Transplantation Rénale

Paris, 75970, France

Location

Hôpital civil, Service de Néphrologie et Transplantation

Strasbourg, 67091, France

Location

Hôpital Foch, Service de Néphrologie Transplantation

Suresnes, 92151, France

Location

Hôpital Rangueil, Service de Néphrologie, HTA, Dialyse, Transplantation

Toulouse, 31059, France

Location

Hôpital Bretonneau, Service de Néphrologie

Tours, 37044, France

Location

Related Publications (1)

  • Matignon M, Lelievre JD, Lahiani A, Abbassi K, Desvaux D, Diallo A, Peraldi MN, Taburet AM, Saillard J, Delaugerre C, Costagliola D, Assoumou L, Grimbert P; ANRS 153 TREVE study group. Low incidence of acute rejection within 6 months of kidney transplantation in HIV-infected recipients treated with raltegravir: the Agence Nationale de Recherche sur le Sida et les Hepatites Virales (ANRS) 153 TREVE trial. HIV Med. 2019 Mar;20(3):202-213. doi: 10.1111/hiv.12700. Epub 2019 Jan 27.

    PMID: 30688008RESULT

Related Links

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Philippe GRIMBERT, MD

    CHU Henri-Mondor

    PRINCIPAL INVESTIGATOR

  • Dominique COSTAGLIOLA, PHD

    INSERM U943

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2011

First Posted

October 17, 2011

Study Start

December 1, 2011

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

April 13, 2026

Record last verified: 2016-07

Locations

FR(14)