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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001004-35 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Raltegravir | Experimental | Raltegravir associated to an antiretroviral regimen without ritonavir boosted antiprotease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltegravir | Drug | Introduction of Raltegravir 2 days after renal transplantation within an antiretroviral regimen without ritonavir boosted antiprotease |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute clinical and subclinical renal graft rejection | 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Permanent:
Temporary:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe GRIMBERT, MD | CHU Henri-Mondor | Principal Investigator |
| Dominique COSTAGLIOLA, PHD | INSERM U943 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Pellegrin, Service de Nephrologie, Transplantation Rénale, Dialyse | Bordeaux | 33076 | France | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30688008 | Result | 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. |
| Label | URL |
|---|---|
| French National Agency for Research on AIDS and viral Hepatitis | View source |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| One year graft survival | One year graft survival, compared to non HIV-infected transplanted patients, using data provided by French Biomedicines Agency | 1 year |
| Patients' survival | 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 | 1 year |
| Phenotyping of lymphocytic infiltrates in case of acute rejection | 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. | 1 year |
| Incidence of AIDS defined diseases and severe morbidity diseases after renal transplantation | Severe morbidity diseases include: pathological infections, malignancies, metabolic and cardiovascular diseases. | 1 year |
| Immunological and virologic status after renal transplantation | 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. | 1 year |
| Evaluation of the switch by raltegravir at the time of renal transplantation | 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. | 1 year |
| Viral load control after switch by antiretroviral treatment including raltegravir after renal transplantation | 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. | 1 year |
| Survival and waiting period of HIV patients registered on French biomedicine agency for renal transplantation | 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 ) | 1 year |
| Measurement of Area under plasma concentration (AUC) variability of immunosuppressive drugs after introduction of antiretroviral regimen containing Raltegravir | 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. | 1 year |
| CHU De Caen, Service de Néphrologie Hémodialyse |
| Caen |
| 14033 |
| France |
| Hôpital Henri Mondor, Service de Néphrologie Transplantation | Créteil | 94010 | France |
| Hôpital Kremlin Bicêtre, Service de Néphrologie | Le Kremlin-Bicêtre | 94275 | France |
| CHRU Lille, Service de néphrologie | Lille | 59037 | France |
| CHU de Nantes, Service de Néphrologie et Immunologie Clinique | Nantes | 44093 | France |
| Hôpital Pasteur, Service de Néphrologie - Transplantation | Nice | 06002 | France |
| Hopital Saint Louis, Service de Néphrologie | Paris | 75010 | France |
| Hôpital Necker, Service de Néphrologie adulte | Paris | 75743 | France |
| Hôpital TENON, Urgences Néphrologiques et Transplantation Rénale | Paris | 75970 | France |
| Hôpital civil, Service de Néphrologie et Transplantation | Strasbourg | 67091 | France |
| Hôpital Foch, Service de Néphrologie Transplantation | Suresnes | 92151 | France |
| Hôpital Rangueil, Service de Néphrologie, HTA, Dialyse, Transplantation | Toulouse | 31059 | France |
| Hôpital Bretonneau, Service de Néphrologie | Tours | 37044 | France |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |