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


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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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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

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


Actg a5201 switch to atv r monotherapy1

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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