Table 3.

Lumefantrine Pharmacokinetics Following a 6-Dose Regimen of Artemether-Lumefantrine in Human Immunodeficiency Virus (HIV)-Uninfected and HIV-Infected Children

Pharmacokinetic Parameter	HIV-Uninfected	HIV-Infected			Ratio (P Value)
	No ART	EFV	LPV/r	NVP	EFV/No ART	LPV/No ART	NVP/No ART
Intensive PK arm	n = 54a	n = 31	n = 30	n = 30
Cmax, ng/mL, geometric mean (90% CI)	5782 (5025–6652)	4725 (3921–5694)	8905 (7366–11 000)	6281 (5203–7582)	0.82 (.15)	1.54 (.003)	1.09 (.56)
Tmax, h	4.0 (0.0–8.0)	4.2 (0.6–8.0)	4.1 (0.0–8.1)	8.0 (0.4–8.0)	1.1 (.05)	1.0 (.43)	2.0 (.13)
T1/2, h	64.3 (52.0–120.6)	23.7 (21.8–46.0)	98.7 (88.4–119.1)	63.4 (46.8–111.1)	0.369 (<.0001)	1.54 (.13)	0.988 (.51)
AUC0-∞, h × ug/mL, geometric mean (90% CI)	270 (232–313)	130 (107–157)	579 (477–704)	278 (228–339)	0.48 (<.0001)	2.14 (<.0001)	1.03 (.84)
Intensive + sparse sampling PK arms	n = 186b	n = 48c	n = 70d	n = 62e
C7d, ng/mL	340 (257–531)	111 (63–192)	1140 (515–2220)	426 (282–733)	0.30 (<.0001)	3.4 (<.0001)	1.3 (.13)
C14d, ng/mL	86 (59–137)	BLQ (BLQ–BLQ)	323 (174–584)	115 (68–178)	<1 (<.0001)	3.8 (<.0001)	1.3 (.05)
C21d, ng/mL	BLQ (BLQ–63)	BLQ (BLQ–BLQ)	159 (81–275)	BLQ (BLQ–83)	(.002)	>1 (<.0001)	(.28)

Data are presented as median (interquartile range) unless otherwise specified. Significance level: α = .0083. All comparisons made using mixed-models repeated measures analysis of log-transformed values.

Abbreviations: ART, antiretroviral therapy; AUC, area under the concentration-time curve; BLQ, below the limit of quantitation; CI, confidence interval; C_max, maximal concentration; EFV, efavirenz; HIV, human immunodeficiency virus; LPV, lopinavir; NVP, nevirapine; PK, pharmacokinetics; r, ritonavir; T_1/2, elimination half-life; T_max, time to maximal concentration.

^a n = 52 for T_1/2 and AUC.

^b n = 183 (C_14d) and 176 (C_21d).

^c n = 46 (C_14d) and 44 (C_21d).

^d n = 65 (C_14d and C_21d).

^e n = 60 (C_14d) and 59 (C_21d).