IMPAACT 2020

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.

Site selection was completed in January 2025 and was open to all IMPAACT sites; protocol-specific sites with experience with tuberculosis studies were also invited to participate. Planned sites are located in Brazil, Haiti, India, South Africa, Tanzania, Thailand, Uganda, and Zimbabwe.