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IMPAACT P1108 Primary Results Presented at 2024 Union World Conference on Lung Health

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15 November 2024 - The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network proudly announced the publication of primary results from the IMPAACT P1108 study at the 2024 Union World Conference on Lung Health today.

About IMPAACT P1108
IMPAACT P1108 is a Phase I/II, open-label, single-arm, exposure-controlled dose finding modified age de-escalation study of bedaquiline (BDQ) in infants, children, and adolescents living with and without HIV, with clinically diagnosed or confirmed rifampin-resistant tuberculosis. The study began enrolling in September 2017 and completed accrual in August 2023. The study enrolled 54 evaluable infants, children, and adolescents in Haiti and South Africa. All participants received the adult formulation of BDQ for 24 weeks.
 
Study Results
Primary results of the study, presented by Simon Schaaf on behalf of the IMPAACT P1108 protocol team, indicated that BDQ was safe and well-tolerated in children across all ages at the BDQ dosing evaluated, with pharmacokinetic exposures within the adult target range. Additionally, there were no drug-related adverse events that resulted in discontinuation of BDQ.

Prior P1108 interim results informed World Health Organization tuberculosis guidelines in 2018 and 2022 resulting in BDQ access for children of all ages. The study is anticipated to close to follow-up by August 2025.

IMPAACT 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 rifampin-resistant tuberculosis.
IMPAACT 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 rifampin-resistant tuberculosis.