Study Status
Participants Off Study and Primary Analysis Completed
DAIDS Number
11884
IND Number
131,832
Clinical Trials Link
Primary Protocol Team Members
Summary
P1108 is a Phase I/II, open-label, single-arm, exposure-controlled dose finding study of BDQ in infants, children, and adolescents living with and without HIV, with clinically diagnosed or bacteriologically confirmed rifampin-resistant tuberculosis (RR-TB). The study is designed to evaluate the PK, safety, and tolerability of BDQ over 24 weeks.