At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Parallel Group, Phase 2A, Randomised, Open Label Treatment Study to Assess the Early Bactericidal Activity, Safety and Tolerability of GSK3036656 Administered as a Two Drug Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin-susceptible Pulmonary Tuberculosis
In Brief
A Phase 2 clinical trial evaluating GSK3036656, Bedaquiline, and 6 other interventions for Tuberculosis. Completed, enrolled 127 participants across 1 site.
Signals
Detailed Summary
This study measured the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics of GSK3036656 in combination with either delamanid, bedaquiline or BTZ-043 and 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 reverted to the standard treatment (RIFAFOUR e-275) once the study treatment (Day 1 to Day 14) was completed.
Study Details
Timeline
Arms & Interventions
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
Interventions
GSK3036656 was administered.
Bedaquiline was administered.
Delamanid was administered.
RIFAFOUR e-275 was administered.
BTZ-043 was administered.
Pretomanid was administered.
Linezolid was administered.
Moxifloxacin was administered.