Overview

Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in Combination With Delamanid or Bedaquiline, Delamanid in Combination With Bedaquiline, or Standard of Care in Male and Female Participants Aged 18 to 65 Years With Pulmonary Tub

Status:
Not yet recruiting

Trial end date:
2023-07-20

Target enrollment:

Participant gender:

Summary

This study aims to measure the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics with GSK3036656 in combination with either delamanid or bedaquiline, 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. RIFAFOUR e-275 is a registered trademark of Sanofi-Aventis

Phase:

Phase 2

Details

Lead Sponsor:

GlaxoSmithKline

Collaborator:

Click-TB Consortium

Treatments:

Bedaquiline
GSK656