Skip to main content
OpenTrials
Completed

NCT Number: NCT01453192

Renal Transplantation and Raltegravir in HIV-Infected Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV-1 Infection Chronic Disease Chronic Renal Insufficiency Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Pellegrin, Service de Nephrologie, Transplantation Rénale, Dialyse, Bordeaux, France

Loading trial locations.

About this study

Antiretroviral treatment of HIV-1 Infection might interact with immunosuppressive treatments which increase rejection of renal graft incidence.

In addition HIV infection may be modified together with cardiovascular risk. Patients participating to this study will receive after transplantation antiretroviral regimen including Raltegravir.

Raltegravir treatment does not interact with immunosuppressive drugs and thus seems to be the treatment of choice to be associated with immunosuppressive drugs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • HCV infection (PCR-positive)

Treatment and study plan

raltegravir

Drug

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

Other names: Isentress

Primary outcomes

  1. Incidence of acute clinical renal graft rejection

    Time frame: 6 months

    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

Secondary outcomes

  1. Incidence of acute clinical and subclinical renal graft rejection

    Time frame: 1 year

    Incidence of acute clinical and subclinical renal graft rejection up to 1 year after renal transplantation defined only by renal histology (without creatinine modification). Histology is performed on routine renal graft biopsy 3 months and 1 year after transplantation.

  2. One year graft survival

    Time frame: 1 year

    One year graft survival, compared to non HIV-infected transplanted patients, using data provided by French Biomedicines Agency

  3. Patients' survival

    Time frame: 1 year

    Patients survival, compared to:

    • chronic dialysis HIV patients still listed on the transplantation waiting list - transplanted non-HIV patients using data provide by French Biomedicine Agency

  4. Phenotyping of lymphocytic infiltrates in case of acute rejection

    Time frame: 1 year

    The aim of the immunological phenotyping is to analyse the expression of activation markers between different TCD4 and TCD8 sub-population, this phenotyping will be compared to those observed in acute cell-mediated rejection occurring in the historical cohort of Non-HIV patients. In addition, the rate and expression of Treg population will be evaluated.

  5. Incidence of AIDS defined diseases and severe morbidity diseases after renal transplantation

    Time frame: 1 year

    Severe morbidity diseases include: pathological infections, malignancies, metabolic and cardiovascular diseases.

  6. Immunological and virologic status after renal transplantation

    Time frame: 1 year

    Immunological (lymphocyte activation and inflammatory parameters) and virologic status (kinetics of viral replication: HIV RNA in blood, total HIV DNA in PBMC) monitoring after renal transplantation. These parameters will be compared with pre-transplant status.

  7. Evaluation of the switch by raltegravir at the time of renal transplantation

    Time frame: 1 year

    Assessment of ARV medications change and introduction of raltegravir at the time of renal transplantation in terms of reduction of pharmacokinetic interaction between antiretroviral regimen including raltegravir and immunosupressive treatments. In addition, virological efficacy of antiretroviral treatment including Raltegravir will be evaluated.

  8. Viral load control after switch by antiretroviral treatment including raltegravir after renal transplantation

    Time frame: 1 year

    The aim of this study is to evaluate at the time of renal transplantation the virologic efficiency after the switch by an antiretroviral regimen including Raltegravir in terms of viral load control an virological failure as Raltegravir is known for its low genetic barrier.

  9. Survival and waiting period of HIV patients registered on French biomedicine agency for renal transplantation

    Time frame: 1 year

    Assessment of HIV patients' waiting period until renal transplantation and survival of patients registered on French biomedicine agency waiting-list compared to Non-HIV population (data provided by French Biomedicine Agency )

  10. Measurement of Area under plasma concentration (AUC) variability of immunosuppressive drugs after introduction of antiretroviral regimen containing Raltegravir

    Time frame: 1 year

    Area under plasma concentration (AUC) of Raltegravir and immunosuppressive drugs (Tacrolimus and Mycophenolate Mophetyl) will be measured as well as residual concentration of Tacrolimus. This study is performed in order to verify immunosupressive treatments dosage adaptation.

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

National, Multicenter, Phase III Prospective Trial About Clinical and Immunological Follow-up After Renal Transplantation in HIV-1 Infected Patients With End Stage Chronic Renal Insufficiency

Acronym: ANRS153TREVE

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 17, 2011
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.