Table 1.
Group | Vs. Placebo | Vs. CQ | CQ | AZ | Predicted maximum ∆QTcF effect due to AZ, msec | |||||
---|---|---|---|---|---|---|---|---|---|---|
Maximum ∆QTcF, msec | Time of maximum ∆QTcF, hours | Maximum ∆QTcF, msec | Time of maximum ∆QTcF, hours | Cmax, µg/mL | Tmax, hours | Cmax, µg/mL | Tmax, hours | Predicted effects at AZ Cmax using p.o. studya | Predicted effects at AZ Cmax using i.v. studyb | |
(90% CI) | (90% CI) | (%CV) | (%CV) | (%CV) | (%CV) | |||||
CQ | 35.0 | 10 | – | – | 0.314 | 7.65 | – | – | – | – |
(29.9–40.2) | (28) | (39) | ||||||||
CQ + 500 mg AZ | 36.2 | 10 | 5.31 | 2 | 0.356 | 6.44 | 0.53 | 1.44 | 3.78 | 0.72 |
(31.0–41.6) | (0.19–10.4) | (35) | (47) | (33) | (38) | |||||
CQ + 1000 mg AZ | 36.9 | 10 | 6.51 | 1 | 0.336 | 6.20 | 0.957 | 1.32 | 6.83 | 1.30 |
(31.7–42.0) | (1.38–11.6) | (27) | (58) | (31) | (29) | |||||
CQ + 1500 mg AZ | 35.0 | 6 | 8.88 | 2 | 0.334 | 6.27 | 1.54 | 1.35 | 11.00 | 2.09 |
(29.7–40.4) | (3.56–14.2) | (22) | (68) | (28) | (30) |
∆QTcF, Fridericia corrected QT interval; AZ, azithromycin; CI, confidence interval; Cmax, maximum plasma concentration; CQ, chloroquine; %CV, coefficient of variation in percent; Tmax, time to maximum plasma concentration.
Azithromycin plus chloroquine p.o. study analysis.
Azithromycin i.v. study analysis.