HRZE Fasted/Fed in Newly Diagnosed TB

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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?

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborators: Gadjah Mada University; University of Groningen

Criteria

Inclusion Criteria:

• Patients with TB who are starting with HRZE therapy

• Age > 18 years old

• Written informed consent

Exclusion Criteria:

• Use of antacids, which cannot be discontinued for study days

• Active, unstable hepatic disease (with jaundice, HRZ)