Renal Transplantation and Raltegravir in HIV-Infected Patients (ANRS153 TREVE)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official 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|
- Incidence of acute clinical renal graft rejection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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
- Incidence of acute clinical and subclinical renal graft rejection [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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.
- One year graft survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]One year graft survival, compared to non HIV-infected transplanted patients, using data provided by French Biomedicines Agency
- Patients' survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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
- Phenotyping of lymphocytic infiltrates in case of acute rejection [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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.
- Incidence of AIDS defined diseases and severe morbidity diseases after renal transplantation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Severe morbidity diseases include: pathological infections, malignancies, metabolic and cardiovascular diseases.
- Immunological and virologic status after renal transplantation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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.
- Evaluation of the switch by raltegravir at the time of renal transplantation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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.
- Viral load control after switch by antiretroviral treatment including raltegravir after renal transplantation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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.
- Survival and waiting period of HIV patients registered on French biomedicine agency for renal transplantation [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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 )
- Measurement of Area under plasma concentration (AUC) variability of immunosuppressive drugs after introduction of antiretroviral regimen containing Raltegravir [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Raltegravir associated to an antiretroviral regimen without ritonavir boosted antiprotease
Introduction of Raltegravir 2 days after renal transplantation within an antiretroviral regimen without ritonavir boosted antiprotease
Other Name: Isentress
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01453192
|Contact: Philippe GRIMBERT, MD||+33 firstname.lastname@example.org|
|Contact: Marie MATIGNON, MD||+33 email@example.com|
|Hôpital Pellegrin, Service de Nephrologie, Transplantation Rénale, Dialyse||Not yet recruiting|
|Bordeaux, France, 33076|
|Contact: Pierre MERVILLE|
|Principal Investigator: Pierre MERVILLE|
|CHU De Caen, Service de Néphrologie Hémodialyse||Recruiting|
|Caen, France, 14033|
|Contact: Bruno HURAULT DE LIGNY|
|Principal Investigator: Bruneau HURAULT DE LIGNY|
|Hôpital Henri Mondor, Service de Néphrologie Transplantation||Recruiting|
|Créteil, France, 94010|
|Contact: Philippe Grimbert, Pr|
|Principal Investigator: Philippe Grimbert|
|Hôpital Kremlin Bicêtre, Service de Néphrologie||Recruiting|
|Kremlin Bicêtre, France, 94275|
|Contact: Antoine DURRBACH, MD|
|Principal Investigator: Antoine DURRBACH, MD|
|CHRU Lille, Service de néphrologie||Not yet recruiting|
|Lille, France, 59037|
|Contact: Marc HAZZAN|
|Principal Investigator: Marc HAZZAN|
|CHU de Nantes, Service de Néphrologie et Immunologie Clinique||Not yet recruiting|
|Nantes, France, 44093|
|Contact: Jacques DANTAL|
|Principal Investigator: Jacques DANTAL|
|Hôpital Pasteur, Service de Néphrologie - Transplantation||Not yet recruiting|
|Nice, France, 06002|
|Contact: Elisabeth CASSUTO|
|Principal Investigator: Elisabeth CASSUTO|
|Hôpital TENON, Urgences Néphrologiques et Transplantation Rénale||Not yet recruiting|
|Paris, France, 75970|
|Contact: Eric RONDEAU|
|Principal Investigator: Eric RONDEAU|
|Hopital Saint Louis, Service de Néphrologie||Not yet recruiting|
|Paris, France, 75010|
|Contact: Marie-Noëlle PERALDI|
|Principal Investigator: Marie-Noëlle PERALDI|
|Hôpital Necker, Service de Néphrologie adulte||Not yet recruiting|
|Paris, France, 75743|
|Contact: Christophe LEGENDRE|
|Principal Investigator: Christophe LEGENDRE|
|Hôpital civil, Service de Néphrologie et Transplantation||Not yet recruiting|
|Strasbourg, France, 67091|
|Contact: Bruno MOULIN|
|Principal Investigator: Bruno MOULIN|
|Hôpital Foch, Service de Néphrologie Transplantation||Not yet recruiting|
|Suresnes, France, 92151|
|Contact: Leila TRICOT|
|Principal Investigator: Leila TRICOT|
|Hôpital Rangueil, Service de Néphrologie, HTA, Dialyse, Transplantation||Not yet recruiting|
|Toulouse, France, 31059|
|Contact: Lionel ROSTAING|
|Principal Investigator: Lionel ROSTAING|
|Hôpital Bretonneau, Service de Néphrologie||Not yet recruiting|
|Tours, France, 37044|
|Contact: Yvon LEBRANCHU|
|Principal Investigator: Yvon LEBRANCHU|
|Principal Investigator:||Philippe GRIMBERT, MD||CHU Henri-Mondor|
|Study Director:||Dominique COSTAGLIOLA, PHD||INSERM U943|