1 / 3

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

cicely
Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related