Status:
COMPLETED
Renal Transplantation and Raltegravir in HIV-Infected Patients
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV-1 Infection
Chronic Renal Insufficiency
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01453192
Start Date
December 1 2011
End Date
November 1 2015
Last Update
July 12 2016
Active Locations (14)
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1
Hôpital Pellegrin, Service de Nephrologie, Transplantation Rénale, Dialyse
Bordeaux, France, 33076
2
CHU De Caen, Service de Néphrologie Hémodialyse
Caen, France, 14033
3
Hôpital Henri Mondor, Service de Néphrologie Transplantation
Créteil, France, 94010
4
Hôpital Kremlin Bicêtre, Service de Néphrologie
Le Kremlin-Bicêtre, France, 94275