Back to Studies

P1108

A Phase I/II, Open-Label, Single Arm Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Bedaquiline (BDQ) Given in Combination with an Individualized Rifampin-Resistant Tuberculosis (RR-TB) Therapy in Infants, Children and Adolescents with RR-TB Disease, Living with or without HIV

DAIDS Number

11884

IND Number

131,832

Clinical Trials Link

Summary

P1108 is a Phase I/II, open-label, single-arm, exposure-controlled dose finding modified age de-escalation study of BDQ in infants, children, and adolescents living with and without HIV, with clinically diagnosed or confirmed multidrug-resistant tuberculosis. The study is designed to evaluate the PK, safety, and tolerability of BDQ over 24 weeks from the initiation of study treatment.

Loading study documents...
Loading study sites...
Loading study protocol team...
Loading study press...
Loading study publications/presentations...