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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
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.
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