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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Raltegravir 400 mg twice a day + Maraviroc 300 mg twice a day
Hôpital Pitié Salpétrière
Paris, France
Virological failure
Occurrence of virological failure, as verified by 2 consecutive plasma viral load measurements \> 50 copies/mL, taken 2 to 4 weeks apart at most, during the first 24 weeks.
Time frame: Week 24
Viro-immunological efficacy
* 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.
Time frame: Between baseline and W48
Tolerability criteria and metabolic impact
* 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
Time frame: Between baseline and W48
Compliance
• Assessment of compliance conducted at screening and at W24 and 48.
Time frame: Between baseline and W48
Quality of life
• Assessment of health-related quality of life conducted at baseline and at W24 and 48.
Time frame: Between baseline and W48
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