CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
Bedaquilinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02906007
NCT02906007Phase 2Completed
CompareCT.gov

A Phase I/II, Open-Label, Single Arm Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Bedaquiline (BDQ) Given in Combination With an Individualized Rifampin-Resistant Tuberculosis (RR-TB) Therapy in Infants, Children, and Adolescents With RR-TB Disease, Living With or Without HIV

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Sep 19, 2016·Updated Sep 4, 2025

In Brief

A Phase 2 clinical trial evaluating Bedaquiline for Tuberculosis and HIV. Completed, enrolled 54 participants across 4 sites in 2 countries.

Detailed Summary

P1108 was a Phase I/II, open-label, single-arm, exposure-controlled dose finding study of BDQ in infants, children, and adolescents living with and without HIV, with clinically diagnosed or bacteriologically confirmed rifampin-resistant tuberculosis (RR-TB). The study was designed to evaluate the PK, safety, and tolerability of BDQ over 24 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis, HIV
CountriesHaiti, South Africa
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 19, 2016
Enrollment StartSep 21, 2017
Primary CompletionFeb 7, 2024
Study CompletionApr 30, 2025
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 9.8 years ago

Interventions

Bedaquilinedrug

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.