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

Pending

Non-US

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.
1108 study training

Sites where the study is implemented:

CRS ID Site Name City Country

30022

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

Port-au-Prince

Haiti

31441

BJ Medical College CRS

Pune, Maharashtra

India

31790

Desmond Tutu TB Centre - Stellenbosch University (SU) CRS

Cape Town

South Africa

31929

Sizwe CRS

Johannesburg

South Africa

31976

PHRU Matlosana

Klerksdorp

South Africa

Study contacts:

Study Co-Chair: Anneke Hesseling

Study Vice-Chair: Hendrik Schaaf

DAIDS Medical Officer: Elizabeth (Betsy) Smith

NICHD Medical Officer: Rohan Hazra

Clinical Trials Specialist: Kathryn Lypen

Clinical Trials Specialist: Patricia Morgan

Clinical Trials Specialist: Jacquelyn Mountcastle

DAIDS Clinical Representative: Judi Miller

Data Manager: Amanda Golner

Data Manager: Bonnie Zimmer

Investigator: Sharon Nachman

Laboratory Data Manager (LDM): Oswald Dadson

Laboratory Specialist: Diane Costello

Laboratory Technologist: William Kabat

Pharmacologist: Kelly Dooley

Protocol Pharmacist: Thucuma Sise

Statistician: Carmelita Alvero

Statistician: Terence Fenton

Laboratory Pharmacologist: Peter Smith

Laboratory Pharmacologist: Lubbe Wiesner

Pharmacometrician: Mats Karlsson

Pharmacometrician: Elin Svensson

 

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.