Clinical trial NCT01453192: Renal Transplantation and Raltegravir in HIV-Infected Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV-1 Infection
Chronic Renal Insufficiency
Keywords: Raltegravir
Renal transplantation
HIV-1
Acute renal graft rejection
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-10-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Incidence of acute clinical renal graft rejection
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of acute clinical and subclinical renal graft rejection
timeFrame: 1 year
measure: One year graft survival
timeFrame: 1 year
measure: Patients' survival
timeFrame: 1 year
measure: Phenotyping of lymphocytic infiltrates in case of acute rejection
timeFrame: 1 year
measure: Incidence of AIDS defined diseases and severe morbidity diseases after renal transplantation
timeFrame: 1 year
measure: Immunological and virologic status after renal transplantation
timeFrame: 1 year
measure: Evaluation of the switch by raltegravir at the time of renal transplantation
timeFrame: 1 year
measure: Viral load control after switch by antiretroviral treatment including raltegravir after renal transplantation
timeFrame: 1 year
measure: Survival and waiting period of HIV patients registered on French biomedicine agency for renal transplantation
timeFrame: 1 year
measure: Measurement of Area under plasma concentration (AUC) variability of immunosuppressive drugs after introduction of antiretroviral regimen containing Raltegravir
timeFrame: 1 year
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Pellegrin, Service de Nephrologie, Transplantation Rénale, Dialyse
city: Caen
country: France
facility: CHU De Caen, Service de Néphrologie Hémodialyse
city: Créteil
country: France
facility: Hôpital Henri Mondor, Service de Néphrologie Transplantation
city: Kremlin Bicêtre
country: France
facility: Hôpital Kremlin Bicêtre, Service de Néphrologie
city: Lille
country: France
facility: CHRU Lille, Service de néphrologie
city: Nantes
country: France
facility: CHU de Nantes, Service de Néphrologie et Immunologie Clinique
city: Nice
country: France
facility: Hôpital Pasteur, Service de Néphrologie - Transplantation
city: Paris
country: France
facility: Hopital Saint Louis, Service de Néphrologie
city: Paris
country: France
facility: Hôpital Necker, Service de Néphrologie adulte
city: Paris
country: France
facility: Hôpital TENON, Urgences Néphrologiques et Transplantation Rénale
city: Strasbourg
country: France
facility: Hôpital civil, Service de Néphrologie et Transplantation
city: Suresnes
country: France
facility: Hôpital Foch, Service de Néphrologie Transplantation
city: Toulouse
country: France
facility: Hôpital Rangueil, Service de Néphrologie, HTA, Dialyse, Transplantation
city: Tours
country: France
facility: Hôpital Bretonneau, Service de Néphrologie
Study officials:
affiliation: CHU Henri-Mondor
name: Philippe GRIMBERT, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: INSERM U943
name: Dominique COSTAGLIOLA, PHD
role: STUDY_DIRECTOR
References: