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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

Enrolling

DAIDS Number

38754

IND Number

158,882

Clinical Trials Link

Summary

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.

Site selection was completed in March 2022 and was open to all IMPAACT sites; protocol-specific sites and sites affiliated with other NIH-supported HIV research networks with experience with tuberculosis studies were also invited to participate. Planned sites are located in Brazil, India, South Africa, Tanzania, and Thailand.

Study Trainings

Regional Training: South Africa

Webinar Training: Thailand

Training Worksheets

Study Chair

DAIDS Medical Officer

NICHD Medical Officer

Clinical Research Manager

Community Program Manager

DAIDS Protocol Pharmacist

ICAB Representative

Investigator

Laboratory Data Manager (LDM)

Laboratory Specialist

Laboratory Technologist

Pharmacometrician

Westat Representative