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Renal Transplantation and Raltegravir in HIV-Infected Patients

Information source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV-1 Infection; Chronic Renal Insufficiency

Intervention: Raltegravir (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Official(s) and/or principal investigator(s):
Philippe GRIMBERT, MD, Principal Investigator, Affiliation: CHU Henri-Mondor
Dominique COSTAGLIOLA, PHD, Study Director, Affiliation: INSERM U943

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.

Clinical Details

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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of acute clinical renal graft rejection

Secondary outcome:

Incidence of acute clinical and subclinical renal graft rejection

One year graft survival

Patients' survival

Phenotyping of lymphocytic infiltrates in case of acute rejection

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

Immunological and virologic status after renal transplantation

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

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

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

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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)

Locations and Contacts

Hôpital Pellegrin, Service de Nephrologie, Transplantation Rénale, Dialyse, Bordeaux 33076, France

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, 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

Additional Information

French National Agency for Research on AIDS and viral Hepatitis

Starting date: December 2011
Last updated: October 28, 2014

Page last updated: August 23, 2015

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