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IMPAACT 2034 Results Presented at 2025 Union World Conference on Lung Health

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The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network shared new interim data from IMPAACT 2034 today at the 2025 Union World Conference on Lung Health

Interim Data

On behalf of the IMPAACT 2034 team, the protocol chair, Ethel Weld, presented data showing that a single dose of pretomanid was safe, well-tolerated, and achieved pharmacokinetic (PK) exposures comparable to adults in female children with rifampicin-resistant tuberculosis. Twenty-eight participants enrolled at sites in South Africa and Thailand were included in the analysis. IMPAACT 2034 is the first clinical study to evaluate pretomanid in children with TB and helps support ongoing work to expand treatment options for children with tuberculosis that is resistant to some medications.

About IMPAACT 2034

IMPAACT 2034 is a Phase I, multi-site, open-label, pharmacokinetic (PK), safety, and acceptability study of a single-dose of pretomanid in children with rifampicin-resistant tuberculosis. Participants are given a single-dose of pretomanid, added to their TB treatment regimen, with intensive PK sampling and a visit to assess safety two weeks later. The study is sponsored by the National Institutes of Health (NIH), with study drug and additional funding from TB Alliance.

View the presentation slides here and read the press release here

Mother and child consulting with doctor
IMPAACT 2034 is a Phase I, multi-site, open-label, pharmacokinetic (PK), safety, and acceptability study of a single-dose of pretomanid in children with rifampicin-resistant tuberculosis.