Table 1.
Subject disposition and demographics
| Dolutegravir (n = 32) | Dolutegravir + boceprevir (n = 16) | Dolutegravir + telaprevir (n = 16) | Overall (n = 32) | |
|---|---|---|---|---|
| Subject disposition* | ||||
| Planned subjects | 32 | 16 | 16 | 32 |
| Randomized subjects | 32 | 16 | 16 | 32 |
| Safety population | 32 (100) | 16 (100) | 16 (100) | 32 (100) |
| PK concentration population | 32 (100) | 16 (100) | 16 (100) | 32 (100) |
| PK summary population | 32 (100) | 16 (100) | 16 (100) | 32 (100) |
| Subjects completed as planned | 32 (100) | 13 (81) | 15 (94) | 28 (88) |
| Subjects withdrawn | 0 | 3 (19) | 1 (6) | 4 (13) |
| Subjects withdrawn because of AEs | 0 | 3 (19) | 1 (6) | 4 (13) |
| Subject demographics | ||||
| Age (years)† | 42.5 (16.56) | 45.2 (17.71) | 39.9 (15.44) | 42.5 (16.56) |
| Sex* | ||||
| Male | 19 (59) | 10 (63) | 9 (56) | 19 (59) |
| Female | 13 (41) | 6 (38) | 7 (44) | 13 (41) |
| Body mass index (kg m−2)† | 25.8 (3.31) | 25.7 (3.25) | 25.8 (3.47) | 25.8 (3.31) |
| Height (cm)† | 169 (9.99) | 169 (10.3) | 169 (9.98) | 169 (9.99) |
| Weight (kg)† | 73.8 (13.3) | 73.9 (13.4) | 73.7 (13.7) | 73.8 (13.3) |
| Ethnicity* | ||||
| Hispanic or Latino | 11 (34) | 9 (56) | 2 (13) | 11 (34) |
| Not Hispanic or Latino | 21 (66) | 7 (44) | 14 (88) | 21 (66) |
| Race* | ||||
| African American/African heritage | 4 (13) | 1 (6) | 3 (19) | 4 (13) |
| American Indian or Alaskan native | 3 (9) | 2 (13) | 1 (6) | 3 (9) |
| White, Arabic/North African heritage | 1 (3) | 1 (6) | 0 | 1 (3) |
| White, Caucasian/European heritage | 23 (72) | 12 (75) | 11 (69) | 23 (72) |
| Mixed race | 1 (3) | 0 | 1 (6) | 1 (3) |
Abbreviations are as follows: AE, adverse event; PK, pharmacokinetic.
*
n (%).
†
Mean (SD).