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P1108

A Phase I/II, Open-Label, Single Arm Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Bedaquiline (BDQ) in Combination with Optimized Individualized Multidrug-Resistant Tuberculosis (MDR-TB) Therapy in HIV-Infected and HIV-Uninfected Infants, Children and Adolescents with MDR-TB Disease

Study Status

Enrolling

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.

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