TABLE 1.
Comparison of plasma raltegravir PK for healthy young men administered multiple doses with and without coadministration of multiple doses of TDFa
| Treatment | GM (CI) for parameter (n = 9):
|
|||
|---|---|---|---|---|
| C12 (nM)b | AUC0-12 (μM h−1)b | Cmax (μM)b | Tmax (h) | |
| Raltegravir alone (95% CI) | 142.3 (86.0-35.5) | 10.29 (6.56-16.13) | 2.87 (1.75-4.71) | 1.5c |
| Raltegravir + tenofovir (95% CI) | 146.4 (88.5-242.4) | 15.35 (9.79-24.07) | 4.71 (2.87-7.72) | 3.0c |
| Raltegravir + tenofovir-raltegravir ratio (90% CI) | 1.03 (0.73-1.45) | 1.49 (1.15-1.94) | 1.64 (1.16-2.32) | 1.0 (−0.3-1.8)d |
| P | 0.879 | 0.023 | 0.029 | 0.281 |
a
Subjects were administered multiple doses of raltegravir (400 mg twice daily) with and without coadministration of multiple doses of TDF (300 mg once daily).
b
The GM was computed from the least-squares estimate from an ANOVA performed on the natural-log-transformed values.
c
Median reported for Tmax.
d
Hodges-Lehman estimate of median treatment difference and 90% CI for true median treatment difference.