Adequacy of the New Pediatric Isoniazid/Rifampin/Pyrazinamide (HRZ) Tablet

CompletedOBSERVATIONAL
Enrollment

92

Participants

Timeline

Start Date

January 28, 2019

Primary Completion Date

August 31, 2024

Study Completion Date

August 31, 2024

Conditions
TuberculosisHuman Immunodeficiency VirusCoinfection
Interventions
OTHER

Observational PK study

The study team will examine the PK and tolerability of the new HRZ 50/75/150 mg dispersible tablet in children with TB with and without HIV coinfection. Intensive PK testing will be performed after at least 4 weeks of treatment in children on first-line anti-TB therapy using the new pediatric HRZ FDC tablet.

Trial Locations (1)

Unknown

Kwame Nkrumah University of Science and Technology, Kumasi

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

University of Florida

OTHER

NCT03800381 - Adequacy of the New Pediatric Isoniazid/Rifampin/Pyrazinamide (HRZ) Tablet | Biotech Hunter | Biotech Hunter