TABLE 1

Lumefantrine pharmacokinetic parameters for participants in step 1a

ParameterGeometric mean value for study group (95% CI)Geometric mean ratio for group (95% CI) (P value)
ART naive (n = 6)NVP (n = 6)LPV/r (n = 6)EFV (n = 6)NVP/ART naiveLPV/r/ART naiveEFV/ART naive
AUC0–14 days (h · μg/ml)513 (374–703)1,226 (943–1,594)1,476 (1,019–2,139)239 (152–377)2.39 (1.58–3.62) (0.001)2.88 (1.75–4.72) (0.001)0.47 (0.27–0.82) (0.018)
Cmax (μg/ml)8 (6–10)12 (8–17)15 (11–20)5 (3–7)1.50 (1.00–2.23) (0.119)1.88 (1.28–2.68) (0.016)0.63 (0.36–0.89) (0.054)
tmax (h)54 (48–72)72 (48–72)72 (72–72)36 (12–72)0.295b0.060b0.365b
t1/2 (h)152 (72–322)185 (162–212)223 (171–291)60 (44–82)1.22 (0.57–2.62) (0.597)1.47 (0.66–3.26) (0.341)0.39 (0.18–0.90) (0.039)
  • a PK parameters are presented as geometric means (95% confidence intervals), except for tmax (time to reach maximum concentration) values, which are presented as medians (interquartile ranges). P values were calculated using analysis of variance in Stata 15.0 (α = 0.05). NVP, nevirapine-based antiretroviral therapy (ART); EFV, efavirenz-based ART; LPV/r, ritonavir-boosted lopinavir-based ART; AUC0–14 days, area under the concentration-time curve from 0 h to 14 days; Cmax, achieved maximum concentration; t1/2, drug elimination half-life.

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