IMPAACT P1108, Single Arm Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Bedaquiline (BDQ) in Combination with Optimized Individualized Multidrug-Resistant Tuberculosis (MDR-TB) Therapy in HIV-Infected and HIV-Uninfected Infants, Children and Adolescents with MDR-TB Disease

IMPAACT P1108 A Phase I/II, Open-Label, Single Arm Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Bedaquiline (BDQ) in Combination with Optimized Individualized Multidrug-Resistant Tuberculosis (MDR-TB) Therapy in HIV-Infected and HIV-Uninfected Infants, Children and Adolescents with MDR-TB Disease - IMPAACT 1108

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010751

Enrollment

Registered

2017-12-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- HIV-infected and HIV-uninfected infants, children and adolescents treated for clinically diagnosed or confirmed intra-thoracic (pulmonary) MDR-TB

Interventions

Intervention1: Bedaquiline given in combination with an optimized background TB treatment regimen (OBR): 400 mg once per day for two weeks then 200 mg three times per week for 22 weeks 200 mg once per

Eligibility

Inclusion criteria

Inclusion criteria: Weight at enrollment: ï?· Cohort 1: At least 15 kg ï?· Cohort 2: At least 7 kg ï?· Cohort 3: At least 3 kg Documented HIV status Either confirmed or probable MDR-TB Initiated on an OBR MDR-TB regimen as per routine treatment decision

Exclusion criteria

Exclusion criteria: Known or presumed severe extrapulmonary manifestations of TB, including Grades 2 and 3 TB meningitis, osteo-articular TB, Pregnant or lactating A clinically significant active medical condition or concomitant severe (Grade 3 or higher) illness or rapidly deteriorating Known personal or family history of long QT syndromehealth condition (excluding TB), including immune deficiency, A significant cardiac arrhythmia that requires medication or a history of heart disease Mean QTcF interval of > 460 ms

Design outcomes

Primary

Measure	Time frame
Determine the BDQ doses that achieve similar weekly exposure (area under the curve; AUC) of BDQ compared to adults taking BDQ at the standard recommended dose. ï?· Evaluate the safety and tolerability of BDQ over 24 weeks from the initiation of study treatment.Timepoint: 24 weeks	—

Secondary

Measure	Time frame
Evaluate the PK of BDQ over the 24-week dosing period, by HIV status. ï?· Describe the long-term safety and tolerability of BDQ over a 120-week (30-month) total follow-up period, by HIV status. ï?· Describe BDQ concentrations following BDQ treatment discontinuation at 24 weeks, from study Weeks 24 to 120, by HIV status. ï?· Describe the MDR-TB treatment response up to 120 weeks from the initiation of the study, by HIV status.Timepoint: 120 weeks	—

Measure

Time frame

Evaluate the PK of BDQ over the 24-week dosing period, by HIV status. ï?· Describe the long-term safety and tolerability of BDQ over a 120-week (30-month) total follow-up period, by HIV status. ï?· Describe BDQ concentrations following BDQ treatment discontinuation at 24 weeks, from study Weeks 24 to 120, by HIV status. ï?· Describe the MDR-TB treatment response up to 120 weeks from the initiation of the study, by HIV status.Timepoint: 120 weeks

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Countries

Haiti, India, South Africa

Contacts

Public ContactDr Nishi Suryavanshi

BJMC CTU, B J Medical College

vidyamave@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026