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IMPAACT 2034

Phase I Study of the Pharmacokinetics, Safety, and Acceptability of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children with Rifampicin-Resistant Tuberculosis

Study Status

In Development

DAIDS Number

38754

Summary

What is IMPAACT 2034?

IMPAACT 2034 is a Phase I, multi-site, open-label, pharmacokinetic (PK), safety, tolerability, and acceptability study of a single-dose of pretomanid (Pa) in infants, children, and adolescents less than 18 years of age living with or without HIV and confirmed or probable rifampicin-resistant tuberculosis. Participants will be given a single-dose of pretomanid, added to their TB treatment regimen, with intensive PK sampling. After receiving the single dose of Pa, participants will be followed for two weeks for safety.

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