TABLE 1

DP dosing regimens and characteristics of volunteers from three clinical trials conducted between 2010 and 2014 in Anlong Veng, Cambodia

CharacteristicValue(s) for study conducted ina:
201020122013
DP dosing regimenb2DP or 3DP2DP or placebo3DP
Patients studiedPatients infected with P. falciparum and P. vivaxHealthy subjectsPatients infected with P. falciparum or mixed P. falciparum and P. vivax and infections
Total no. of evaluable volunteersc80 (40 receiving 2DP regimen/40 receiving 3DP regimen)69 (47 receiving 2DP regimen/22 receiving placebo)107
Median (IQR):
    Age (yr)32 (27–49)26 (22–56)25 (21–34)
    Wt (kg)56.2 (34–62)60.0 (55–65)56.0 (52–60)
    Ht (cm)163 (160–167)165 (161–169)164 (160–168)
    Body mass index (kg/m2)21.2 (20–22)22.0 (21–24)20.7 (19–23)
    Baseline QTcFm (ms)400 (383–415)390 (378–403)393 (375–410)
    Baseline QTcBm (ms)418 (413–425)396 (393–402)412 (411–421)
    Maximum QTcFm prolongation (ms)431 (425–436)430 (425–440)430 (427–437)
    Maximum QTcBm prolongation (ms)439 (435–447)436 (433–447)439 (436–445)
No. of volunteers with:
    ΔQTcFm of >30 ms4042 (39/3)d76
    ΔQTcBm of >30 ms4026 (22/4)d43
    ΔQTcFm of >60 ms621 (21/0)d17
    ΔQTcBm of >6 0ms97 (5/2)d11
Median (IQR):
    Baseline serum K+ concne (mM)Not assessed3.8 (3.7–4.1)3.6 (3.3–4.0)
    Baseline serum Mg2+ concnf (mg/dl)Not assessed1.9 (1.8–2.0)1.8 (1.6–2.0)
    Time to previous meal prior to 1st dose (h)Not assessed2.9 (1.9–4.5)2.7 (1.8–4.1)
Avg (IQR) time to previous meal prior to all doses (h)Not assessed2.9 (2.0–3.3)(3.6 (3–4.4)
  • a The studies conducted in 2010 (4), 2012 (3), and 2013 (31) have been described previously.

  • b The total DHA-piperaquine phosphate (DP) dose was 360/2,880 mg.

  • c All volunteers were male, except for 3 females in the study conducted in 2013.

  • d Data in parentheses represent the number in each category receiving DP/placebo.

  • e The normal K+ concentration range is 3.5 to 5.1 mM.

  • f The normal Mg2+ concentration range is 1.8 to 2.4 mg/dl.