. Author manuscript; available in PMC: 2021 May 1.

Published in final edited form as: J Acquir Immune Defic Syndr. 2020 May 1;84(1):70–77. doi: 10.1097/QAI.0000000000002294

Table 2.

Cohort 1 Raltegravir Pharmacokinetic Parameters After First Dose for Raltegravir-Naive and Raltegravir-Exposed Neonates

PK Parameter	RAL-Naïve 3 mg/kg Single Dose (N = 6)		RAL-Naïve 2 mg/kg Single Dose (N = 3)		RAL-Exposed 1.5 mg/kg Single Dose (N = 6)

	Geometric Mean (CV%)	Target	Geometric Mean (CV%)	Target	Geometric Mean (CV%)	Target

*AUC_0–24h (mgh/L)**^a	53.9 (34.6%)	Met: 2	44.3 (71.9%)	Met: 1	37.4 (92.7%)	Met: 1
		Above: 4		Above: 2		Above: 4
		Below: 0		Below: 0		Below: 1

C_24h trough (ng/mL)^b	1444 (63.1%)	Met: 6	806 (246.3%)	Met: 3	906 (209.5%)	Met: 6
		Below: 0		Below: 0		Below: 0

C_max (ng/mL)^c	3361 (35.5%)	Met: 6	3405 (38.1%)	Met: 3	2189 (73.3%)	Met: 6
		Above: 0		Above: 0		Above: 0

T_max (hours)	6.5 (76.5%)	N/A	4.4 (4.4%)	N/A	5.2 (85.9%)	N/A

T_1/2 (hours)	11.8 (27.2%)	N/A	17.2 (107.2%)	N/A	12.6 (48.7%)	N/A

AUC_0–24h target 12–40 mg*h/L.

C_24h trough concentration >33 ng/mL.

C_max <8724 ng/mL.

Key to Acronyms: AUC = area under the curve; C_max = maximum concentration; CV = coefficient of variation; PK = pharmacokinetic; RAL = raltegravir; T_1/2 = half-life; T_max = time to reach maximum concentration