Evaluation of Raltegravir Plus Maraviroc Therapy in Controlled HIV Patients Presenting With Lipohypertrophy (ROCnRAL)

• Viro-immunological efficacy [ Time Frame: Between baseline and W48 ] [ Designated as safety issue: Yes ]
  • Proportion of patients with a HIV RNA viral load < 50 copies/mL.
  • Proportion of patients discontinuing the therapy:
  • Plasma genotypic resistance profile where the viral load is > 50 copies/mL.
  • Evaluation of DNA/RNA tropism in the event of failure.
  • Evaluation of plasma HIV RNA where the viral load is < 50 copies/mL, through ultrasensitive PCR testing.
  • Evolution of the CD4 and CD8 T-cell counts.
  • Blood concentration of raltegravir and maraviroc.
• Tolerability criteria and metabolic impact [ Time Frame: Between baseline and W48 ] [ Designated as safety issue: No ]
  • Changes in glucose and lipid balance.
  • Changes in anthropometric measurements.
  • Number and severity of clinical and biological adverse effects.
  • Changes in bone mineral density and body composition, as measured by DEXA scan.
  • Changes in inflammation and endothelial activation markers between baseline and W48
  • Measurement of fat cells differentiation markers in adipose tissue biopsy samples
• Compliance [ Time Frame: Between baseline and W48 ] [ Designated as safety issue: No ]
  • Assessment of compliance conducted at screening and at W24 and 48.
• Quality of life [ Time Frame: Between baseline and W48 ] [ Designated as safety issue: No ]
  • Assessment of health-related quality of life conducted at baseline and at W24 and 48.

Evaluation of antiretroviral therapy combining Raltegravir and Maraviroc in patients with virological success, presenting with clinical lipohypertrophy.

Assess the ability to maintain the plasma HIV viral load below the threshold needed for detection (< 50 copies/mL) at 24 weeks of raltegravir/maraviroc therapy without NRTIs and PIs, in patients with virological success and presenting with clinical lipohypertrophy.

• Human Immunodeficiency Virus
• Lipohypertrophy

Inclusion Criteria:

• Patients infected with HIV-1 type B or CRF02.
• ≥ 18 years old
• Patients who have been receiving antiretroviral therapy for at least 5 years, and whose treatment has been stable for at least 6 months.
• Patients whose plasma viral load has been undetectable (below 200 copies/mL) over the last 24 months, and < 50 copies/mL for at least 12 months.
• Patients with an R5* tropic virus, as determined through DNA and with CD4 nadir ≥ 100/mm3
• Patients presenting with clinical lipohypertrophy recognized by themselves and by their doctors, and defined by increased volume of the abdominal and/or thoracic and/or cervical area (buffalo hump).
• Patients who have never been treated with raltegravir.
• Patients who have never been treated with maraviroc.
• Efficient contraception for women
• Free and informed written consent, signed by the patient and the investigator.
• Patients with health insurance. * To increase the certainty of selecting patients with an R5 virus, the HIV-1 tropism will be determined by the genotype method and interpreted with the Geno2pheno[coreceptor] algorithm and a false positive rate threshold for X4 virus at 20%, rather than the usual 10%.

Exclusion Criteria:

• X4, X4/5 or undetermined tropism of the HIV virus.
• HIV-2 or coinfection HIV-1/HIV-2.
• Chronic viral hepatitis B.
• Chronic viral hepatitis C requiring specific treatment over the first 24 weeks.
• Treatment with growth hormones.
• Hypolipemic or diabetes treatment, begun within the last 3 months.
• Pregnant or breastfeeding women.
• Haemoglobin < 7g/dl, neutrophils < 500/mm3, platelets < 50 000/mm3, creatinine clearance < 50 mL/min, alkaline phosphatases, ASAT, ALAT or bilirubin ≥ 3 times the upper limit of the normal range (N).
• Antiretroviral treatment associated to enzymatic inducer.
• Chronic alcohol consumption.
• Subjects under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship.
• Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase.

• Merck
• ViiV Healthcare