TABLE 1.

Patient demographics, covariates and study designs of the clinical studies of rifampin pharmacokinetics in the South African pulmonary tuberculosis patients included in the rifampin pharmacokinetic modela

CharacteristicData for indicated patient subset(s)
DPM1DPM2BKHCombined
No. of patients9131139261
Study siteD. P. Marais SANTA Centre, Retreat, Western Cape, South AfricaD. P. Marais SANTA Centre, Retreat, Western Cape, South AfricaBrewelskloof Hospital, Worcester, Western Cape, South Africa
Age (yrs)36 (30-43)37 (31-41)36 (28-44)36 (29-44)
No. of female patients/no. of male patients25/662/2975/64102/159
Weight (kg)52.5 (47.3-58.3)59 (55-63)46 (40-51)50 (43.7-56)
Body mass index19.6 (18.1-21)20.6 (19.6-22.9)17.7 (16.2-19.8)18.7 (17.1-20.7)
No. of patients with HIV infectionb21 (25.3%)3 (9.7%)13 (9.5%)37 (14.2%)
Formulation type (single drug/FDC)4/87105/340/31
Study length (wk)261
Typical no. of samples/patient12 (3 per day, twice per wk)13-52 (13 per day on 1-4 occasions)9 (during a single day)2,913c
Sampling schedulePredose and randomly between 0-12 h postdosePredose and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h postdosePredose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 8 h postdose
  • a Continuous variables are given as median (interquartile range).

  • b n = 251 patients.

  • c Total number of samples.