Renal Transplantation and Raltegravir in HIV-Infected Patients (NCT01453192) | Clinical Trial Compass
CompletedPhase 3
Renal Transplantation and Raltegravir in HIV-Infected Patients
France27 participantsStarted 2011-12
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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)