HRZE Fasted/Fed in Newly Diagnosed TB

Tuberculosis Clinical Trial

— FASTFOOD  

Official title:

The Influence of Fasting and Food on the Pharmacokinetics of Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol in Newly Diagnosed TB Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121314
• Other study ID #: UGM-RuG-UMCG-TB-001
• Status: Completed
• Phase: Phase 2
• First received: January 25, 2014
• Last updated: April 7, 2015
• Start date: July 2013
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Yogyakarta, Indonesia: Ethics Committee Universitas Gadjah Mada, Sardjito Teaching HospitalIndonesia: National Agency of Drug and Food Control
• Study type: Interventional

Clinical Trial 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?

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Drug:
• intravenous administration of 1st line TB drugs, day 1
TB drugs IV on day 1 for calculation of bioavailability while fasting or fed

Locations

Country	Name	City	State
Indonesia	Sardjito Central Hospital	Yogyakarta

Sponsors (3)

Lead Sponsor	Collaborator
University Medical Center Groningen	Gadjah Mada University, University of Groningen

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	confounding factors for primary and secondary outcomes	Parameters which may influence the pharmacokinetics of HRZE will be measured at start and end of the study.; BMI, i.e. body weight and length; age; gender; ethnicity; co-morbidity, for instance HIV/AIDS, diabetes (only at start); co-medication: especially HIV medication, prednisolone (may lower INH concentration), antacids (may lower absorption of HRE concentration); chemistry: liver function, renal function, hemoglobulin, albumin, bilirubin; pharmacogenetics	weeks 1 and 8	Yes
Primary	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	3 days - week 1 and week 8	No
Primary	pharmacokinetics (AUC0-8, Cmax, and Tmax) of HRZE	PK curves from venous blood specimens sampled from indwelling venous catheter	11 time points, 3 consecutive days - wk 1 & 8	No
Secondary	To evaluate adverse events of HRZE, week 1 and 8 - while taking food or not	tolerance - acceptance; vomiting, refusal	week 1 - week 8	Yes