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 rejectionOne 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
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