NCT02906007View on ClinicalTrials.gov

Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV

PHASE1/PHASE2CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

September 21, 2017

Primary Completion Date

February 7, 2024

Study Completion Date

April 30, 2025

Conditions

TuberculosisHIV

Interventions

DRUG

Bedaquiline

Participants received bedaquiline (BDQ) once per day through intensive PK sampling visit, then 3 times per week on Monday, Wednesday and Friday through the week 24 visit.

Trial Locations (4)

2574

PHRU Matlosana CRS, Klerksdorp

7505

Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS, Cape Town

HT-6110

Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS, Port-au-Prince

Unknown

Sizwe CRS, Johannesburg

All Listed Sponsors

collaborator

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

NIH

collaborator

National Institute of Mental Health (NIMH)

NIH

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02906007 - Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV | Biotech Hunter | Biotech Hunter