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)

Table 3 Study Outcomes at Week 48

	ABC/3TC/ZDV (N = 138)	ATV+3TC/ZDV (N = 140)
Completed study	103 (74%)	98 (70%)
Prematurely withdrawn ¹	36 (26%)	41 (29%)
Virologic Failures	18 (13%)	17 (12%)
Primary Reason for Withdrawal ² , n (%)
Adverse event	6 (4%)	11 (8%)
Lost to follow-up	12 (9%)	14 (10%)
Protocol defined virologic failure³	16 (12%)	16 (11%)
Subject decision	3 (2%)	1 (<1%)
Protocol violation	0	2 (1%)
Investigator decision	0	3 (2%)
Other⁴	6 (4%)	0

1. One subject in the ATV+3TC/ZDV group had a missing completion status.
2. As reported by study investigators on Study Conclusion case report form.
3. Subjects with confirmed virologic failure with subsequent HIV-1 RNA < 1265 copies/mL were allowed to remain in the study on randomized treatment; therefore the actual number of virologic failures is greater than the number that withdrew from study. In the ABC/3TC/ZDV group, 7 virologic failures completed the study and 2 were lost to follow-up. In the ATV+3TC/ZDV group, 6 virologic failures completed the study and 1 was withdrawn with a protocol violation.
4. Other included (number of subjects): incarceration (2), site not operational due to Hurricane Katrina (3), moved out of state (1).

ISSN: 1742-6405