This study aims to measure the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics with GSK3036656 in combination with either delamanid or bedaquiline or BTZ-043, delamanid in combination with bedaquiline or standard of care for 14 days in participants with newly diagnosed sputum smear positive drug-sensitive pulmonary tuberculosis. Participants will revert to the standard treatment (RIFAFOUR® e-275) once the study treatment (Day 1 to Day 14) has been completed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
127
GSK3036656 will be administered.
Bedaquiline will be administered.
Delamanid will be administered.
RIFAFOUR e-275 will be administered.
BTZ-043 will be administered.
GSK Investigational Site
Bellville, South Africa
Change from Baseline in log10 CFU of Mycobacterium tuberculosis (MTB) (per milliliters of respiratory sputum samples)
The extended early bactericidal activity of each treatment group will be determined by the change from Baseline to Day 14 in log10CFU.
Time frame: Baseline and up to Day 14
Change from Baseline in time to sputum culture positivity
Time to sputum-culture positivity is the time between sample inoculation and detection of mycobacterial growth in the mycobacterium growth indicator tube.
Time frame: Baseline and up to Day 14
Number of participants with serious adverse events
Time frame: Up to Day 28
Number of participants with adverse events of Grade 3 severity or higher
Time frame: Up to Day 28
Number of participants with adverse events related to study drug
Time frame: Up to Day 28
Number of participants withdrawn from the treatment due to adverse events
Time frame: Up to Day 28
Number of participants withdrawn from the study due to adverse events
Time frame: Up to Day 28
Number of participants with electrocardiogram (ECG) values of potential clinical importance (PCI)
Time frame: Up to Day 28
Number of participants with hematology laboratory values of PCI
Time frame: Up to Day 28
Number of participants with clinical chemistry laboratory values of PCI
Time frame: Up to Day 28
Number of participants with vital signs of PCI
Time frame: Up to Day 28
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