Table 3.
Study Outcomes at Week 48
| ABC/3TC/ZDV (N = 138) | ATV+3TC/ZDV (N = 140) | |
| Completed study | 103 (74%) | 98 (70%) |
| Prematurely withdrawn1 | 36 (26%) | 41 (29%) |
| Virologic Failures | 18 (13%) | 17 (12%) |
| Primary Reason for Withdrawal2, 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 In the ATV+3TC/ZDV group, 6 virologic failures completed the study and 1 was withdrawn with a protocol violation.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).