NCT02457208

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 7, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2018

Completed
Last Updated

October 3, 2018

Status Verified

October 1, 2018

Enrollment Period

2.5 years

First QC Date

April 22, 2015

Last Update Submit

October 1, 2018

Conditions

Tuberculosis

Keywords

pharmacokinetics

Outcome Measures

Primary Outcomes (4)

  • Plasma drug levels of Rifampicin

    Rifampicin, Isoniazid, Pyrazinamide and Ethambutol in different study groups

    6 Months

  • Plasma drug levels of Isoniazid

    6 Months

  • Plasma drug levels of Pyrazinamide

    6 Months

  • Plasma drug levels of Ethambutol

    6 Month

Secondary Outcomes (2)

  • Time to negativity of M. tuberculosis

    6 Months

  • Genotyping MTB strains

    6 Months

Study Arms (1)

2HRZE/4HR

EXPERIMENTAL

2HRZE/4HR * Intensive phase: 2 months HRZE - once daily * Continuation phase: 4 months HR - once daily Adults will be treated with fixed dose combination (FDC) tablets containing: Intensive phase (content per tablet) Isoniazid -75 mg, Rifampicin - 150 mg, Pyrazinamide - 400 mg, Ethambutol - 275 mg Continuation phase (content per tablet) Isoniazid 150 mg Rifampicin 300 mg \*Drug dosing will be adjusted by patient body weight.

Drug: Isoniazid (H)Drug: Rifampicin (R)Drug: Pyrazinamide (Z)Drug: Ethambutol (E)

Interventions

Isoniazid (H)DRUG
2HRZE/4HR
Rifampicin (R)DRUG
2HRZE/4HR
Pyrazinamide (Z)DRUG
2HRZE/4HR
Ethambutol (E)DRUG
2HRZE/4HR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical and microbiogical diagnosis of pulmonary TB
  • Males and females aged \>18 years old
  • Willing to comply with study procedures including residing in the TB centre or nearby for six months
  • Written informed consent provided by participant

You may not qualify if:

  • TB treatment in the past
  • Known or suspected pregnancy
  • Enrolled for TB treatment at one of the study sites
  • Known hypersensitivity/intolerance to one or more of anti-TB drugs
  • The MTB strain that shown resistant to Rifampicin, which is the precursor marker of MDR TB detected by a MTB/Rif Xpert Assay
  • Biochemistry test result:
  • Creatinine \> 3 x upper limit of normal (ULN)
  • bilirubin \> 2.5 x ULN
  • AST and/or ALT \> 5 x ULN
  • Refuse to take HIV testing
  • The diagnosed TB patients who choose to take the treatment at a Thai hospital or a hospital in Myanmar
  • The proven non-TB patients by clinical and microbiological diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shoklo Malaria Research Unit

Mae Sot, Changwat Tak, 63110, Thailand

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

IsoniazidProtonsRifampinPyrazinamideEthambutol

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

HydrazinesOrganic ChemicalsIsonicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingCations, MonovalentCationsIonsElectrolytesInorganic ChemicalsHydrogenElementsGasesNucleonsElementary ParticlesPhysical PhenomenaRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingLactams, MacrocyclicMacrocyclic CompoundsPolycyclic CompoundsPyrazinesEthylenediaminesDiaminesPolyaminesAmines

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2015

First Posted

May 29, 2015

Study Start

July 7, 2015

Primary Completion

January 14, 2018

Study Completion

January 14, 2018

Last Updated

October 3, 2018

Record last verified: 2018-10

Locations

TH(1)