Table 1.
Viral load (VL) setpoint at the end of analytic treatment interruption (ATI).
| Viral load setpoint | Arm | N | Median (Q1, Q3) (log10 copies/mL) | pa | Proportion of subjects with VL <5000 copies/mL | pb |
|---|---|---|---|---|---|---|
| Observed (as-treated) | A | 13 | 4.1 (3.5, 4.6) | 0.20 | 4/13 (31%) | 0.096 |
| B | 13 | 4.5 (4.1, 4.8) | 0/13 (0%) | |||
| Worst rankc (Intent-to-treat) | A | 14 | 4.3 (3.5, 4.9) | 0.17 | 4/14 (29%) | 0.042 |
| B | 15 | 4.6 (4.1, 5.2) | 0/15 (0%) | |||
| Carry forwardd (intent-to-treat) | A | 14 | 4.3 (3.5, 4.9) | 0.25 | 4/14 (29%) | 0.042 |
| B | 15 | 4.5 (4.1, 5.2) | 0/15 (0%) |
a
Wilcoxon Rank Sum test.
b
Fisher's exact test.
c
Assign the worst-rank of the primary endpoint to subjects who do not have observed VL endpoint.
d
Carry forward the last observed HIV-1 RNA value (at ATI weeks 4–6) during the ATI for three subjects who did not have an observed VL endpoint.