P1108 (DAIDS ID 11884): 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

Study Status Study Restriction



What is P1108?

P1108 is a Phase I/II, open-label, single-arm, exposure-controlled dose finding modified age de-escalation study of Bedaquiline (BDQ) in HIV-infected and HIV-uninfected pediatric populations with clinically diagnosed or confirmed intra-thoracic multidrug-resistant tuberculosis (MDR-TB). The study is designed to evaluate the pharmacokinetics, safety and tolerability of BDQ over 24 weeks from the initiation of study treatment.

Study documents:

      Please note - as of November 2016, the South African Department of Health has requested that all import permit applications be accompanied by either an MTA or a letter from the country of origin, indicating their knowledge about the export. Please contact Jennifer Norman (jennifer.norman@uct.ac.za) with any questions.
  • ECG Implementation Materials

1108 study training

Sites where the study is implemented:

CRS ID Site Name City Country


Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS




BJ Medical College CRS

Pune, Maharashtra



Desmond Tutu TB Centre - Stellenbosch University (SU) CRS

Cape Town

South Africa


Sizwe CRS


South Africa


PHRU Matlosana


South Africa

Study contacts:

Study Chair: Anneke Hesseling

Study Vice-Chair: Simon Schaaf

DAIDS Medical Officer: Patrick Jean-Philippe

DAIDS Medical Officer: Tafadzwa Kasambira

NICHD Medical Officer: Sai Majji

NICHD Medical Officer: Jack Moye

Clinical Trials Specialist: Sarah Bradford

Clinical Trials Specialist: Sarah Buisson

Clinical Trials Specialist: Iris Mustich

CAB representative: Gwynneth Hendricks

Community Program Manager: Cheryl Blanchette

Data Manager: Mattie Bartlett

Data Manager: Meghan Dolina

Data Manager: Amanda Golner

Laboratory Data Manager (LDM): Jennifer McClaren

Laboratory Data Manager (LDM): Kyle Whitson

Laboratory Specialist: Diane Costello

Laboratory Specialist: Samantha Solomon

Laboratory Technologist: Neeta Pradhan

Laboratory Technologist: Willy Ssengooba

Pharmacologist: Kelly Dooley

Protocol Pharmacist: Thucuma Sise

Statistician: Paula Britto

Statistician: Grace Montepiedra

Audiologist: Kayleen Jacobs

Laboratory Pharmacologist: Peter Smith

Laboratory Pharmacologist: Lubbe Wiesner

Microbiologist: Anne-Marie Demers

Pharmacometrician: Mats Karlsson

Pharmacometrician: Elin Svensson

Protocol Cardiologist: James Nielsen


Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.