Table 2.
Mean of the Log-10 Cumulative p24 (SD) and Estimated Difference of Means, Relative to the Placebo Arm and Relative to the Baseline Levels in the Dapivirine Gel Arm, with 95% Confidence Interval
| Arm/collection time | Mean (SD) | Mean difference (95% CI) |
|
|---|---|---|---|
| vs. Placebo | vs. DPV baseline | ||
| Placebo arm, all times | 2.94 (0.6) | ||
| DPV arm | |||
| Baseline | 2.72 (0.81) | −0.21 (−0.72 to 0.3) | |
| After single dose | |||
| 30–60 min | 1.84 (1.29) | −1.02 (−1.64 to −0.41)a | −0.81 (−1.34 to −0.27)a |
| 120 min | 1.48 (1.33) | −1.51 (−2.11 to −0.92)a | −1.3 (−1.81 to −0.79)a |
| 24 h | 2.76 (0.61) | −0.08 (−0.72 to 0.56) | 0.13 (−0.43 to 0.7) |
| 48 h | 3.22 (0.64) | −0.13 (−0.91 to 0.64) | 0.08 (−0.63 to 0.79) |
| 72 h | 2.87 (0.66) | 0.09 (−0.59 to 0.76) | 0.3 (−0.3 to 0.9) |
| After seven daily doses | |||
| 30–60 min | 2.22 (1.2) | −0.65 (−1.26 to −0.03) | −0.44 (−0.97 to 0.1) |
| 120 min | 2.58 (1.09) | −0.44 (−1.08 to 0.2) | −0.23 (−0.79 to 0.33) |
| 24 h | 2.36 (1.04) | −0.54 (−1.21 to 0.13) | −0.33 (−0.93 to 0.27) |
| 48 h | 2.95 (1.12) | −0.44 (−1.29 to 0.42) | −0.22 (−1.03 to 0.58) |
| 72 h | 3.02 (0.65) | 0.27 (−0.41 to 0.94) | 0.48 (−0.12 to 1.08) |
a
Statistically significant p-value under a 5% significance level after adjustment for multiple comparisons by the Benjamini-Hochberg procedure.
CI, confidence interval.