Table 1.
Demographics of Study Infants
| Demographic | Pharmacokinetics and Safety Population | |
|---|---|---|
| Control Arm (n = 6) | Rifampicin Arm (n = 21) | |
| Male/Female | 3/3 | 13/8 |
| Weight, kga | 6.0 (5.8 to 8.0) | 6.4 (5.2 to 7.1) |
| Weight-band, kg | ||
| 3–<6 | 3 (50%) | 11 (52%) |
| 6–<10 | 3 (50%) | 10 (48%) |
| Length, cma | 64.5 (60.8 to 66.3) | 62.0 (58.5 to 67.0) |
| Age, moa | 7.4 (6.4 to 8.9) | 6.6 (5.6 to 10.5) |
| Weight-for-height z scorea | −0.8 (−2.1 to 0.5) | −0.7 (−1.7 to 0.5) |
| Weight-for-age z scorea | −2.4 (−3.0 to -0.5) | −2.5 (−4.4 to −0.9) |
| Baseline viral load, log10 copies/mLa | 5.6 (4.0 to 6.6) | 6.0 (5.6 to 6.8) |
| Treatment naive upon enrollment in the main trial | 5 (83%) | 19 (90%) |
| Dolutegravir dose mg/kg/24 ha,b | 1.86 (1.09 to 2.36) | 2.66 (2.00 to 4.16) |
| Confirmed tuberculosis diagnosisc | ||
| Yes | 0 (0%) | 6 (29%) |
| No | 6 (100%) | 15 (71%) |
Demographic data represent the infant on the day of their pharmacokinetic visit unless specified otherwise.
aReported median (interquartile range).
bInfants in the rifampicin arm received dolutegravir twice daily and hence received a 2-times higher mg/kg/24 hour dose compared with the control arm using dolutegravir once daily.
cDiagnosed using GeneXpert and/or tuberculosis urine lipoarabinomannan.