DOWNLOAD THIS SLIDE KIT

• Limited pilot study, no control arm

Design :

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%

• 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