Renal Transplantation and Raltegravir in HIV-Infected Patients

ANRS, Emerging Infectious Diseases27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV-1 Infection Chronic Renal Insufficiency

Interventions

RaltegravirDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Locations (14)

Hôpital Pellegrin, Service de Nephrologie, Transplantation Rénale, Dialyse

Bordeaux, France

CHU De Caen, Service de Néphrologie Hémodialyse

Caen, France

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 1 year

One year graft survival

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

Time frame: 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

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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