Table 1.

Number of subjects and observations included in the integrated mother–neonate PK analysis set and demographic variables, stratified by population, study, and cohort

Population	Raltegravir‐unexposed neonates		Infants		Raltegravir‐exposed neonates		Mothers
Study	P1110	P1110	P1066	P1066	P1110	P1097	P1097
Total number of subjects	10	26	13	11	6	19	19
Raltegravir administration	2 × single dose	Multiple dose 0–6 weeks	Multiple dose b.i.d.	Multiple dose b.i.d.	In utero + 2 × single dose	In utero	400 mg b.i.d.
Number of PK samples	79	288	121	123	54	75	19
Age range at enrollment	0–2 days	0–2 days	6 months to <2 years	4 weeks to <6 months	0–2 days	0–1 day	Unknown
Age range for PK sampling	0–11 days	0–6 weeks	6 months to <2.4 years	5 weeks to <1 year	0–11 days	0–2 days	Samples taken <1 hour postpartuma
Weight range, kg	2.3–4.2	2.2–5.3	5.5–14	3.7–10.4	2.2–3.4	2.2–4.1	Unknown
Sex, M/F	4/6	14/12	8/5	7/4	4/2	14/5	0/19

PK, pharmacokinetic; b.i.d., twice daily.

^aMaternal sample of one mother was obtained 2.8 hours postpartum.