TABLE 3

qPCR findings during baseline and followup of the different groups of treatment of DNDi-CH-E1224-001 and MSF-DNDi PCR sampling optimization clinical studiesa

Clinical trial, treatment group, and parameterValue(s) (S1+S2+S3) at:
BL2 mo4 mo6 mo12 mo
DNDi-CH-E1224-001
    Placebo
        N4646464646
        No. (%) positive46 (100)34 (73.9)37 (80.4)40 (87.0)36 (78.3)
        No. (%) quantifiable9 (19.6)15 (44.1)9 (24.3)14 (35.0)16 (44.4)
        Median (IQR) (par. eq./ml)2.2 (2.0-4.1)2.2 (1.9–4.3)3.3 (2.1–4.1)3.1 (2.1–3.7)2.7 (1.9–5.3)
    E1224 LD
        N4848484847
        No. (%) positive48 (100)5 (10.4)18 (37.5)32 (66.7)36 (76.6)
        No. (%) quantifiable14 (29.2)0 (0.0)6 (33.3)10 (31.3)12 (33.3)
        Median (IQR) (par. eq./ml)3.5 (2.6–7.0)2.1 (1.9–2.5)2.1 (1.7–2.4)2.2 (2.1–4.3)
    E1224 SD
        N4545444345
        No. (%) positive45 (100)4 (8.9)31 (70.5)33 (76.7)38 (84.4)
        No. (%) quantifiable9 (20.0)0 (0.0)8 (25.8)5 (15.2)12 (31.6)
        Median (IQR) (par. eq./ml)2.3 (2.0–2.9)2.5 (1.9–3.5)2.2 (1.9–2.6)2.8 (2.1–4.5)
    E1224 HD
        N4242414141
        No. (%) positive42 (100)7 (16.7)9 (22.0)14 (34.1)23 (56.1)
        No. (%) quantifiable11 (26.2)0 (0.0)0 (0.0)1 (7.1)6 (26.1)
        Median (IQR) (par. eq./ml)2.5 (1.9–3.4)1.82.0 (1.9–2.2)
    BZN
        N4444434344
        No. (%) positive44 (100)3 (6.8)0 (0.0)2 (4.7)2 (4.5)
        No. (%) quantifiable11 (25.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
        Median (IQR) (par. eq./ml)2.1 (1.9–2.7)
MSF-DNDi sampling study
    BZN
        N137121115116
        No. (%) positive137 (100)28 (23.1)11 (9.6)6 (5.2)
        No. (%) quantifiable47 (34.3)0 (0.0)1 (9.1)0 (0.0)
        Median (IQR) (par. eq./ml)2.8 (1.9–4.6)2.2
  • a BL, baseline. LD, SD, and HD, low, short, and high dosages.