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Table 1 Virologic Failure Definition

From: A randomized, controlled trial of initial anti-retroviral therapy with abacavir/lamivudine/zidovudine twice-daily compared to atazanavir once-daily with lamivudine/zidovudine twice-daily in HIV-infected patients over 48 weeks (ESS100327, the ACTION Study)

Prior to or at Week 24

1. Failure to have ≥ 1 log HIV-1 RNA drop from baseline by week 12

2. Reduction of plasma HIV-1 RNA to <50 copies/mL on two occasions followed by increase of ≥ 400 copies/mL on two consecutive times prior to week 24*

3. Failure to have <400 copies/mL by week 24

After Week 24

4. Plasma HIV-1 RNA ≥ 400 copies/mL on two consecutive occasions after week 24*

5. Subject had an HIV-1 RNA ≥ 400 copies/mL at week 48 with confirmation

  1. * virologic rebound any time at or after confirmed virologic failure of ≥ 1265 copies/mL on two consecutive occasions resulted in subject's discontinuation from the study as a virologic withdrawal.