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Renal Transplantation and Raltegravir in HIV-Infected Patients

CompletedPhase 3

Sponsor: ANRS, Emerging Infectious Diseases

Conditions: HIV-1 Infection, Chronic Renal Insufficiency

Interventions: Raltegravir

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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)

Locations (14)

Bordeaux, France
Caen, France
Créteil, France
Le Kremlin-Bicêtre, France
Lille, France
Nantes, France
Nice, France
Paris, France
Paris, France
Paris, France
Strasbourg, France
Suresnes, France
Toulouse, France
Tours, France