WHO recommends to take TB drugs while fasting: if TB drugs are taken with food, perhaps drug concentrations are too low; on the other hand: if this is not tolerated, drugs could also be taken with food. Do lower drug concentrations - with improved adherence to therapy - outweigh the disadvantage of lower drug blood concentrations over time? How exactly do the drug concentrations over time (pharmacokinetics) compare between fasting and fed conditions, especially in the early stage of TB treatment when patients are relatively sick, and relatively poorly tolerate TB drugs?
To evaluate the influence of concomitant food ingestion on the pharmacokinetics of HRZE in newly diagnosed TB patients To evaluate the influence of early disease on the PK parameters of HRZE in TB patients To compare the pharmacokinetics of HRZE in the early stage of disease with the pharmacokinetics of HRZE in more stable condition in newly diagnosed TB patients To evaluate adverse events of HRZE in TB patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
TB drugs IV on day 1 for calculation of bioavailability while fasting or fed
Sardjito Central Hospital
Yogyakarta, Indonesia
pharmacokinetics
pharmacokinetics (AUC0-8, Cmax, and Tmax); comparison between TB patients who take HRZE concomitant with food and TB patients who take HRZE concomitant without food, weeks 1 and 8 of treatment
Time frame: 3 days - week 1 and week 8
pharmacokinetics (AUC0-8, Cmax, and Tmax) of HRZE
PK curves from venous blood specimens sampled from indwelling venous catheter
Time frame: 11 time points, 3 consecutive days - wk 1 & 8
To evaluate adverse events of HRZE, week 1 and 8 - while taking food or not
tolerance - acceptance; vomiting, refusal
Time frame: week 1 - week 8
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