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Switch to ATV/r monotherapy - ATARITMO - Swedish Study - ACTG A5201 - OREY

Switch to ATV/r monotherapy - ATARITMO - Swedish Study - ACTG A5201 - OREY. ACTG A5201: Switch to ATV/r monotherapy. Design. Open-label Single-arm Pilot trial. W6. W48. HIV+ ≥ 18 years On first ARV regimen with ≥ 2 NRTI + ≥ 1 PI for > 48 weeks HIV-1 RNA < 50 c/mL > 48 weeks

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Switch to ATV/r monotherapy - ATARITMO - Swedish Study - ACTG A5201 - OREY

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  1. Switch to ATV/r monotherapy • - ATARITMO • - Swedish Study • - ACTG A5201 • - OREY

  2. ACTG A5201: Switch to ATV/r monotherapy • Design Open-label Single-arm Pilot trial W6 W48 HIV+ ≥ 18 years On first ARV regimen with ≥ 2 NRTI + ≥ 1 PI for > 48 weeks HIV-1 RNA < 50 c/mL > 48 weeks CD4 > 250/mm3 N = 36 N = 34 If no treatment-limiting toxicities and plasma HIV-1 RNA < 50 c/mL at W3 • Primary endpoint • Time to virologic failure (2 consecutive HIV-1 RNA ≥ 200 c/mL) • 85% power to detect a difference between W24 success rate of 75% with ATV/r alone vs a nominal rate of 90% Wilkin TJ, JID 2009;199:866-71 ACTG A5201

  3. ACTG A5201: Switch to ATV/r monotherapy • Prior PI therapy • Median CD4 cell count/mm3: at inclusion = 616 ; nadir = 253 • Kaplan-Meier estimate of the probability of virologic successat W48 = 0.88 (lower limit of the 90% 1-sided CI: 0.81) • In the 4 subjects with confirmed virologic failure there were no major PI-resistance mutations detected • Grade 3 or 4 elevation of total biliribun: 17/34 subjects • Conclusion • Limited pilot study, no control arm Wilkin TJ, JID 2009;199:866-71 ACTG A5201

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