Renal Transplantation and Raltegravir in HIV-Infected Patients

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Raltegravir Potassium

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)