Table 1.

Summary of AZ pharmacokinetic parameters when AZ (5 mg/kg once daily) was administered alone or in combination with ATQ (30 mg/kg once daily) to HIV-1-infected children for at least 10 days

SubjectaAge (yr)Study phase (n)Body wt (kg)Cmax (ng/ml)Tmax (h)Cpredose (ng/ml)C24 (ng/ml)CSS (ng/ml)AUC0–24 (ng · h/ml)CL/ F (liters/h/kg)
112ALONEb
SIM30.113111628389495.25
STAG31.147311723561,4013.44
210ALONE26.812622946621,5433.14
SIM26.811142325491,1534.21
STAG26.419612747872,0542.40
310ALONE28.520316246751,8912.67
SIM27.69024637441,1954.37
STAG28.212923531431,1044.63
510ALONE24.52102631001293,3021.48
SIM25.112127284932,3042.08
STAG23.710266056821,7912.83
66ALONE20.74842630286956.95
SIM20.22742818215399.19
STAG20.836512121641,3913.46
74ALONE14.232425646711,9662.44
SIM14.433912029581,5882.97
STAG14.26216136401,1204.27
85ALONE17.825012235461,3433.68
SIM17.112723330411,0354.97
STAGc
99ALONE28.744721032542225,5610.93
SIM29.03154681041373,8121.34
STAG28.122016260661,8442.86
Mean ± SDALONE (7)23.0 ± 5.6230 ± 1302 ± 152 ± 2980 ± 8091 ± 662,329 ± 1,6323.04 ± 1.96
SIM (8)23.8 ± 5.8158 ± 1102 ± 138 ± 2244 ± 3260 ± 371,572 ± 1,0434.30 ± 2.41
STAG (7)24.6 ± 5.7221 ± 1492 ± 240 ± 2039 ± 1662 ± 181,529 ± 371  3.41 ± 0.81
  • a Subjects 10 and 4 were excluded from pharmacokinetic analyses due to either noncompliance with the dosing schedule (subject 10) or inexplicably low (below the quantification limit of 10 ng/ml) serum AZ concentrations throughout the sampling period (subject 4).

  • b Study not conducted.

  • c Data were excluded because the patient missed the AZ dose 1 day prior to the pharmacokinetic study.