PK Study of Anti-TB Drugs

• Status: Completed
• Trial end date: 2018-01-14
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective descriptive and pharmacokinetic study will be conducted among newly diagnosed patients registered in the two SMRU TB clinics located on the Thai-Myanmar border. This study aims to recruit (1) 30 adults with HIV co-infection and (2) 30 adults without HIV co-infection in one year. Patients will be given the standard 6 month anti-TB drugs as per WHO guidelines.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Oxford
• Treatments: Ethambutol; Isoniazid; Pyrazinamide; Rifampin

Criteria

Inclusion Criteria:

1. Clinical and microbiogical diagnosis of pulmonary TB

2. Males and females aged >18 years old

3. Willing to comply with study procedures including residing in the TB centre or nearby for six months

4. Written informed consent provided by participant

Exclusion Criteria:

1. TB treatment in the past

2. Known or suspected pregnancy

3. Enrolled for TB treatment at one of the study sites

4. Known hypersensitivity/intolerance to one or more of anti-TB drugs

5. The MTB strain that shown resistant to Rifampicin, which is the precursor marker of MDR TB detected by a MTB/Rif Xpert Assay

6. Biochemistry test result:

1. Creatinine > 3 x upper limit of normal (ULN)

2. bilirubin > 2.5 x ULN

3. AST and/or ALT > 5 x ULN

7. Refuse to take HIV testing

8. The diagnosed TB patients who choose to take the treatment at a Thai hospital or a hospital in Myanmar

9. The proven non-TB patients by clinical and microbiological diagnosis.