Renal Transplantation and Raltegravir in HIV-Infected Patients (ANRS153TREVE)

ANRS, Emerging Infectious Diseases

Status and phase: Completed; Phase 3

Conditions: HIV-1 Infection; Chronic Renal Insufficiency

Treatments: Drug: Raltegravir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01453192

ANRS 153 TREVE (Registry Identifier)

2011-001004-35

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Raltegravir

Experimental group

Description:

Raltegravir associated to an antiretroviral regimen without ritonavir boosted antiprotease

Treatment:

Drug: Raltegravir