TABLE 3.
RTV PK parameters in ACTG study 5283 subjects before and after DMPA administrationa
| Parameter | AUC0–12 h (ng · h/ml) |
Cmin (ng/ml) |
Cmax (ng/ml) |
Tmax (h) |
CL/F (liters/h) |
t1/2 (h) |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Without DMPA (n = 24) | With DMPA | Without DMPA | With DMPA | Without DMPA | With DMPA | Without DMPA | With DMPA | Without DMPA | With DMPA | Without DMPA | With DMPA | |
| Mean | 5,609.01 | 5,453.02 | 209.29 | 207.68 | 913.67 | 892.17 | 3.67 | 2.83 | 20.98 | 21.53 | 6.45 | 5.94 |
| SD | 2,087.71 | 2,223.54 | 133.95 | 105.60 | 411.94 | 481.70 | 2.66 | 1.13 | 10.64 | 9.00 | 5.08 | 2.06 |
| Median | 5,176.79 | 5,014.73 | 181.00 | 194.50 | 884.00 | 726.00 | 3.00 | 3.00 | 19.32 | 19.94 | 4.56 | 6.32 |
| IQR (Q1, Q3) | 4,098.11, 7,451.07 | 3,648.21, 6,925.08 | 122.00, 281.00 | 112.00, 283.00 | 597.00, 1,080.00 | 586.50, 1,088.50 | 2.00, 4.50 | 2.00, 3.00 | 13.45, 24.40 | 14.48, 27.41 | 3.66, 8.07 | 4.31, 7.15 |
| Range (minimum, maximum) | 1,605.05, 9,858.86 | 2,325.59, 10,011.32 | 25.00, 527.00 | 68.90, 486.00 | 224.00, 2,070.00 | 268.00, 1,950.00 | 1.00, 12.00 | 1.00, 6.00 | 10.14, 62.30 | 9.99, 43.00 | 1.28, 22.59 | 2.23, 10.62 |
| P valueb | 0.598 | 1.000 | 0.541 | 0.140 | 0.216 | 0.768 | ||||||
a
Data are for 24 subjects in each treatment group for all parameters except t1/2 without DMPA, for which there were 23 subjects. AUC0–12 h, area under the concentration-time curve over the dosing period of 12 h; Cmin, minimum concentration; Cmax, maximum concentration; Tmax, time to Cmax; CL/F, apparent clearance; t1/2, half-life; Q1, first quartile; Q3, third quartile.
b
P value by Wilcoxon signed-rank test of changes between before DMPA (without DMPA) and after DMPA (with DMPA).