Grant Support

Current Grants

Title: IMPAACT Leadership Group – Vice Chair IMPAACT 2005 Protocol
Dates: 12/2015 – current
Project #: UM1AI068632-09
Funding Agency: NIH
Project Total or Direct Costs: ~$32,803 through 11/2020 (15% FTE up to NIH maximum for duration of the trial)
PI: AJ Garcia-Prats
Role: Protocol Vice-Chair
Percent of Effort: 5%
Brief explanation: This phase I/II trial will evaluate the optimal dose, safety of the new TB drug delamanid in children with MDR-TB, including in HIV-infected children, and is expected to influence international TB drug dosing guidelines. As the Protocol Chair I am leading the design of this protocol, and will oversee the trial implementation, analysis, interpretation and dissemination.

Title: Stellenbosch University Clinical Trial Unit (SUN-CTU); Clinical Research Site 31790, Desmond Tutu TB Centre, IMPAACT Network
Dates: 12/2013 – 11/2020
Project #: NIH UM1AI069521-08
Funding Agency: NIH
Project Total or Direct Costs: ~$2.1 million
PI: Anneke C. Hesseling
Role: Co-investigator, Desmond Tutu TB Centre Clinical Research Site
Percent of Effort: 10%
Brief explanation: This funding provides core support to the DTTC’s IMPAACT network clinical trial site, which implements multiple network trials in children. As co-investigator I support the PI in strategic thinking about direction of the site and oversee the clinical care, study implementation at the site, one of the most productive childhood TB trial sites globally.

Title: A Phase I/II study of the pharmacokinetics, safety and tolerability of clofazimine in HIV-infected and uninfected children treated for rifampicin-resistant tuberculosis
Dates: 11/2019-10/2021
Project #: N/A
Funding Agency: Novartis Pharmaceuticals
Project Total or Direct Costs: $750,000
PI: AC Hesseling
Role: Co-Principal Investigator
Percent of Effort: 2.5%
Brief explanation: This study will characterize the pharmacokinetics, optimal dose, safety and acceptability of a 50 mg capsule of clofazimine in children with MDR-TB; this data is expected to contribute to expanding the label of this formulation to include a pediatric indication. I led the protocol writing and will provide overall support to the South Africa-based trial site.

Title: BENEFIT Kids: Better Evidence and Formulations for Improved MDR-TB Treatment for Children
Dates: 10/2019-09/2022
Project #: N/A
Funding Agency: Unitaid
Project Total or Direct Costs: $18.9 million
PI: AJ Garcia-Prats
Role: Principal Investigator
Percent of Effort: 50%
Brief explanation: This three-year Project led by Stellenbosch University (SU) and a Consortium of 8 international partners is one of the largest research grants in SU’s history, and aims to improve access for children to better MDR-TB treatment and prevention through multiple evidence syntheses, five clinical trials, and the development of multiple child-friendly formulations of 2nd-line TB drugs. As the PI, I am responsible for overseeing all aspects of the project implementation, including overseeing all Consortium partners, liaising with the funder, ensuring timely completion of all deliverables.

Title: Novel strategies to improve tuberculosis case finding in children with severe acute malnutrition.
Dates: 04/2021-03/2023
Project #: N/A
Funding Agency: Thrasher Research Fund
Project Total or Direct Costs: $26,750
PI: B Vonasek
Role: Mentor
Percent of Effort: 0%
Brief explanation: This project will investigate the effectiveness of three non-invasive tests to help in the diagnosis of tuberculosis in children with severe acute malnutrition.


Completed Grants

Title: Optimizing and operationalizing pediatric drug-resistant tuberculosis treatment
Dates: 03/2015 – 02/2021
Project #: NIH 1R01HD083047-01
Funding Agency: NIH
Project Total or Direct Costs: ~$1.56 million
PI: AJ Garcia-Prats & R Savic
Role: Co-Principal Investigator
Percent of Effort: 25%
Brief explanation: This observational study aims to characterize the PK, safety and acceptability of model-optimized doses of key 2nd-line TB drugs in children with MDR-TB, and has already contributed to international TB drug dosing recommendations. As the PI I led the study design, and am overseeing the implementation, analysis and dissemination of results.

Title: Project Preparation Facility (PPF) for BENEFIT Kids: Better Evidence and Formulations for Improved MDR-TB Treatment for Children
Dates: 10/2018- 09/2019
Project #: N/A
Funding Agency: Unitaid
Project Total or Direct Costs: $110,711
PI: AJ Garcia-Prats
Role: PI
Percent of Effort: 55%
Brief explanation: This funding was awarded to support the development of a full grant application for the BENEFIT Kids project to Unitaid for ultimate approval and implementation. As the PI, I lead all aspects of the proposal development to secure this award and lead the finalization of the Grant Agreement with Unitaid, including finalization of the Project Plan, detailed Project budget, log frame, Gantt chart.

Title: TB-CHAMP (Tuberculosis Child Multidrug-resistant Preventive Therapy Trial): A phase III cluster randomized placebo-controlled trial to assess the efficacy of preventive therapy in child contacts of multidrug-resistant (MDR) tuberculosis (TB).
Dates: 11/2015 – 09/2019
Project #: MR/M007340/1
Funding Agency: British MRC, South African MRC
Project Total or Direct Costs: ~$3.5 million
PI: AC Hesseling
Role: Co-Investigator; Lead Pharmacokinetics in study
Percent of Effort: 5%
Brief explanation: This multicentre trials aims to characterize the efficacy and safety of levofloxacin to prevent MDR-TB in high-risk exposed children and has the potential to influence international TB guidelines. I led a lead-in PK study, and gave input on the study design and will contribute to the interpretation and dissemination of the main study results.

Title: Phase 1, Open-label, Multidose, and Age De-escalation Trial to Assess the Pharmacokinetics, Safety and Tolerability of Delamanid (OPC 67683) in Paediatric Multidrug-resistant Tuberculosis Patients on Therapy with an Optimized Background Regimen of Anti-tuberculosis Drugs, and Phase 2, Open-label, Multiple-dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Delamanid (OPC 67683) in Pediatric
Multidrug-resistant Tuberculosis Patients on Therapy with an Optimized Background
Dates: 06/2014-11/2019
Project #: Otsuka 242-12-232, and 242-12-233
Funding Agency: Otsuka Pharmaceuticals
Project Total or Direct Costs: ~$520,000
PI: AJ Garcia-Prats
Role: Site Principal Investigator
Percent of Effort: 15%
Brief explanation: These multicenter phase I and phase II open-label extension trials were two of the first trials of a new TB drug in children, and will provide the evidence to support a pediatric indication for this critically needed drug. As the Site PI I oversaw all aspects of the trial implementation at our site, and will give input on the results interpretation and dissemination.

Title: WHO research toolkit to support drug and formulation development for infants, children and adolescents living with HIV
Dates: 12/2017– 11/2018
Project #: N/A
Funding Agency: NIH (WHO, UNITAID)
Project Total or Direct Costs: $7,500
PI: AJ Garcia-Prats
Role: Coinfections Module Co-leader
Percent of Effort: 10%
Brief explanation: This WHO-led project aimed to develop a toolkit to identify challenges and outline possible solutions for promoting and accelerating timely, high quality research and development of antiretroviral drug formulations suitable for children. I led the conceptualization and writing of the module on co-infections.

Title: Optimizing rifampicin exposure in children (Opti-Rif): A phase I/II open label multi-cohort dose escalation study to evaluate the pharmacokinetics and safety of increased doses of rifampicin in HIV-negative children with tuberculosis.
Dates: 03/2017 – 02/20219
Project #: N/A
Funding Agency: TB Alliance
Project Total or Direct Costs: $450,000
PI: AC Hesseling
Role: Co-Investigator
Percent of Effort: 15%
Brief explanation: This phase I clinical trial aimed to characterize the pharmacokinetics and short term safety of high doses of rifampicin in children to inform future TB treatment shortening trials. I contributed to the design of the trial protocol, oversaw the clinical implementation at our research site, and have led interpretation and presentation of results.

Title: IMPAACT Leadership Group – Co-Chair TASK002 (BDQ Crush Study)
Dates: 12/2015 – 11/2017
Project #: UM1AI068632
Funding Agency: NIH
Project Total or Direct Costs: ~$8,000
PI: AJ Garcia-Prats
Role: Protocol Co-Chair
Percent of Effort: 5%
Brief explanation: This phase I trial evaluated the relative bioavailability of the new antituberculosis drug bedaquiline when administered as a crushed vs whole tablet. As Protocol Co-Chair I led the writing and development of this trial protocol, interpretation of results and writing of the manuscript, which has impacted international recommendations for MDR-TB treatment in children.

Title: The pharmacokinetics and safety of second-line TB drugs in HIV-infected and –uninfected children with MDR-TB
Dates: 03/2012 – 02/2016
Project #: NIH R01H0069169
Funding Agency: NIH
Project Total or Direct Costs: ~$2.2 million
PI: AC Hesseling
Role: Co-Investigator
Percent of Effort: 50-75%
Brief explanation: As the lead clinician and primarily responsible for implementing this large observational study that aimed to characterize the pharmacokinetics and safety of second-line antituberculosis drugs in children who were treated for multidrug-resistant tuberculosis. I also led the interpretation of results and write-up or co-authored the 12 publications that came from this study to date.

Title: Pediatric tuberculosis – Enabling early detection of children at risk for poor treatment outcomes
Dates: 05/2013 – 03/2017
Project #: N/A
Funding Agency: Thrasher Research Fund
Project Total or Direct Costs: $196,356
PI: S Abdel-Rahman, AC Hesseling
Role: Co-Investigator
Percent of Effort: 5%
Brief explanation: I supported implementation of this study which was validating dried blood spot samples for quantifying antituberculosis drug concentrations in children.

Title: IMPAACT 2020: Shortened Oral Treatment for Multidrug-Resistant Tuberculosis in Infants, Children and Adolescents (SMaRT Kids): A Phase III, Randomized, Multi-Center Trial
Dates: 12/2017– 11/2021
Project #: NIH UM1AI068632
Funding Agency: NIH
Project Total or Direct Costs: $54,056 through 11/2020 (15% FTE up to NIH maximum for duration of the trial)
PI: AJ Garcia-Prats
Role: Protocol Chair
Percent of Effort: 15%
Brief explanation: This multicenter phase II trial will evaluate the safety, acceptability, PK and outcomes of a 6-month all-oral regimen for children with rifampicin-resistant tuberculosis. As the Protocol Chair I am leading the design of this protocol, and will oversee the trial implementation, analysis, interpretation and dissemination.

Title: Assay development and testing to support bedaquiline and delamanid use for MDR-TB treatment in special populations including children and lactating women
Dates: 12/2019-11/2021
Project #: TO13, Study 006
Funding Agency: NIH (NICHD, IMPAACT)
Project Total or Direct Costs: $144,076
PI: AJ Garcia-Prats
Role: Principal Investigator
Percent of Effort: 5%
Brief explanation: This funding will support assay costs from stored samples and analysis of bedaquiline PK and safety in children from the MDRPK2 study, and will support the development of bedaquiline and delamanid breastmilk assays needed for other planned trials. As PI I conceptualized and led the grant writing and will oversee the implementation, write-up of the work.