IMPAACT 2005 (DAIDS ID 20721): A Phase I/II Open-label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination with Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in HIV-infected and HIV-uninfected Children with MDR-TB

Study Status Study Restriction

Pending

Non-US

What is IMPAACT 2005?

IMPAACT 2005 is a Phase I/II open-label, single-arm, multisite study of Delamanid (DLM) in HIV-infected and HIV-uninfected pediatric populations with multidrug-resistant tuberculosis (MDR-TB). The study is designed to characterize the pharmacokinetics of DLM using a model-based approach, and to evaluate safety and tolerability of DLM over 24 weeks 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.
  • 2017 Annual Meeting MDR-TB Training

Sites where the study is implemented:

CRS ID Site Name City Country

12701

Gaborone Prevention/Treatment Trials CRS

Gaborone

Botswana

12702

Molepolole Prevention/Treatment Trials CRS

Molepolole

Botswana

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

5118

Kilimanjaro Christian Medical CRS

Moshi

Tanzania

Study contacts:

Study Chair: Kelly Dooley

Study Vice-Chair: Anthony Garcia-Prats

Study Vice-Chair: Ethel Weld

DAIDS Medical Officer: Elizabeth (Betsy) Smith

NICHD Medical Officer: Jack Moye

Clinical Trials Specialist: Kathryn Lypen

Clinical Trials Specialist: Patricia Morgan

CAB representative: Dichaba Siane

Community Program Manager: Rhonda White

DAIDS Protocol Pharmacist: Oladapo Alli

DAIDS Protocol Pharmacist: Justine Beck

Data Manager: Bonnie Zimmer

Investigator: Anneke Hesseling

Laboratory Data Manager (LDM): Oswald Dadson

Laboratory Data Manager (LDM): Mark Lojacono

Laboratory Specialist: Diane Costello

Laboratory Technologist: Vandana Kulkarni

Laboratory Technologist: Jennifer Norman

Pharmaceutical Company Representative: Jeffrey  Hafkin

Pharmaceutical Company Representative: Suresh Mallikaarjun

Pharmacologist: Mats Karlsson

Pharmacologist: Elin Svensson

Statistician: Grace Montepiedra

Statistician: Leavitt Morrison

Westat Representative: Scott Watson

Microbiologist: Anne-Marie Demers

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.