TABLE 1.
Subject characteristics for the 36 patients enrolled and the 27 patients with evaluable pharmacokinetic sampling
| Characteristica | All accrued subjects (n = 36)
|
Subjects with adequate pharmacokinetic assessments (n = 27)
|
||
|---|---|---|---|---|
| Group A (n = 21) | Group B (n = 15) | Group A (n = 14) | Group B (n = 13) | |
| Gender (no. of subjects) | ||||
| Male | 12 | 9 | 9 | 8 |
| Female | 9 | 6 | 5 | 5 |
| Race or ethnicity (no. of subjects) | ||||
| White, non-Hispanic | 1 | 2 | 1 | 1 |
| Black, non-Hispanic | 16 | 11 | 12 | 10 |
| Hispanic | 4 | 2 | 1 | 2 |
| No. of subjects at age (yr): | ||||
| <15 | 2 | 3 | 1 | 2 |
| 15 to <18 | 5 | 2 | 3 | 2 |
| ≥18 | 14 | 10 | 10 | 9 |
| Median* | 19.7 (17.0, 21.4) | 20.0 (17.2, 22.7) | 19.8 (17.8, 21.4) | 20.0 (18.0, 22.3) |
| Baseline CD4+ count (cells/mm3) | ||||
| 250-500 | 9 | 6 | 6 | 4 |
| >500-1,000 | 11 | 5 | 8 | 5 |
| >1,000 | 0 | 2 | 0 | 2 |
| Missing | 1 | 0 | 0 | 2 |
| Median* | 550 (425, 640) | 531 (421, 830) | 550 (378, 620) | 670 (421, 935) |
| Treatment regimen | ||||
| PI | 9 | 2 | 5 | 2 |
| Non-NRTI | 11 | 12 | 8 | 10 |
| Both PI and non-NRTI | 1 | 1 | 1 | 1 |
a
*, The 25th and 75th percentiles are given in parentheses. PI, protease inhibitor.