TABLE 2

Lumefantrine pharmacokinetic parameters for participants in step 2a

ParameterGeometric mean value for study group (95% CI)Geometric mean ratio (95% CI) (P value)
ART naive (n = 10)LPV/r (n = 15)EFV (n = 15)LPV/r/ART naiveEFV/ART naive
AUC0–14 days (h · μg/ml)1,084 (760–1,547)2,107 (1,654–2,686)1,081 (816–1,432)1.94 (1.26–3.00) (0.004)0.99 (0.63–1.57) (0.991)
Cmax (μg/ml)15 (10–23)19 (16–23)18 (14–23)1.27 (0.81–1.93) (0.265)1.20 (0.75–1.84) (0.456)
tmax (h)66 (24–72)72 (60–72)48 (12–72)0.145b0.340b
t1/2 (h)160 (103–248)190 (154–236)102 (61–170)1.19 (0.73–1.94) (0.438)0.64 (0.32–1.26) (0.217)
Cd7 (μg/ml)1 (0.9–2)4 (3–6)0.5 (0.3–0.8)4.00 (1.72–5.39) (<0.001)0.50 (0.21–0.74) (0.009)
  • a PK parameters are presented as geometric means (95% confidence intervals), except for tmax values, which are presented as medians (interquartile ranges). P values were calculated using analysis of variance in Stata 15.0 (α = 0.05). Cd7, day 7 plasma lumefantrine concentration.

  • b P value only, calculated using the Wilcoxon rank sum test (α = 0.05).