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IMPAACT 2020

Phase II Study of Shortened Oral Treatment for Rifampicin-Resistant Tuberculosis in Children

Study Status

In Development

DAIDS Number

38505

IND Number

TBD

Clinical Trials Link

TBD

Summary

IMPAACT 2020 is a Phase II, multi-site, open-label, study to evaluate the safety, tolerability, treatment outcomes, and acceptability of all-oral, six-month regimens to treat tuberculosis. The study will enroll infants, children, and adolescents less than 15 years of age living with or without HIV and with confirmed or probable rifampicin-resistant tuberculosis. Participants will be assigned to one of two TB treatment regimens based on their resistance profile for 24 weeks and will be followed for a total of 48 weeks. Parents and caregivers will also be enrolled in the study to participate, with their child, in a socio-behavioral component to assess acceptability, priorities, and preferences for TB treatment.

Resumption of the site selection is planned in the first quarter of 2024.

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