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2022 Rome Action Plan on Paediatric HIV & TB

NIAID/NIH

HIV MEDICINES DURING PREGNANCY AND BREASTFEEDING

HIV Clinical Trials Research Networks2 enrolling adults into phase 2/3 clinical trials of new antiretroviral drugs for treatment or prevention, commit to:

1. Implementing the Call to Action3 principles and advocate for other research networks to do the same including reporting of incident pregnancies occurring during the conduct of such studies; permitting women who become pregnant in trials to consent to stay on study drug; and collecting outcomes of pregnancies as well as pregnancy and breastfeeding PK data in women who become pregnant on study.

The National Institute of Allergy and Infectious Disease commits to:

11. Continue to support completion of HPTN 084 pregnancy sub-study (CAB-LA for prevention) in a timely manner.

12. Continue to support completion of enrolment and timely dissemination of results from IMPAACT 2026 for new ARVs for use in pregnancy and postpartum.

13. Support NIAID funded clinical trial research networks to continue to report incident pregnancies occurring during the conduct of studies and collect outcomes of pregnancies as well as pregnancy and breastfeeding PK data in women who become pregnant on study.

14. Support NIAID clinical research networks to continue to ensure appropriate consultation and engagement of community members and community-based organizations through the research cycle for new therapeutics.

15. As appropriate, facilitate completion of embryo-fetal development (FEED/EFD) studies as needed for priority ARVs for use in pregnant and lactating women with established pharma partnerships by end of Phase 2 by applying available contract resources.

16. As appropriate, facilitate completion of pre- and post-natal development studies (PPND) as needed for priority ARVs with established pharma partnership

WHO and Research networks commit to:

61. Working together to collaboratively develop standards to strengthen systematic population data collection, registries, and master protocols to promote alignment and harmonization of studies in pregnant women across studies within the work of the WHO HIV, Hepatitis and STIs Pregnancy

and Breastfeeding Therapeutics Working Group (HHS PTWG) .

62. Ensure appropriate consultation and engagement of community members and communitybased organizations through the research cycle for new therapeutics.

Updates

12. 13. 14. June 2024: Ongoing

15. 16. June 2024: While there are no current activities using contract resources to support FEED/EFD or PPND studies, NIAID contractors with the expertise to conduct these studies are available once priority ARV’s have been identified.

12. Feb 2024: Ongoing

13. Feb 2024: Internal discussions in progress 

14. Feb 2024: Ongoing

15 and 16. Feb 2024: While there are no current activities using contract resources to support FEED/EFD or PPND studies, NIAID contractors with the expertise to conduct these studies are available once priority ARV’s have been identified.

TB DIAGNOSTICS

NIAID commits to:

172. Support grants funded to explore TB biomarkers in children to eventually better diagnose children and to better understand those who will progress to active TB disease.

173. Engage in discussions with FIND and others on whether NIAID can be helpful in achieving the goals of having better understanding of paediatric chest x-ray reading for more accurate TB diagnosis.

Updates

172. June 2024: Ongoing: Supported projects are ongoing.

173. June 2024: Ongoing: Discussion with FIND is ongoing.

172. Feb 2024: Supported projects are ongoing.

173. Feb 2024: Discussion with FIND is ongoing.

HIV MEDICINES FOR CHILDREN

NIAID commits to:

279. Continue to support IMPAACT to determine dosing and safety of DTG dispersible tablets in newborns by third quarter 2024.

280. Continue to support IMPAACT to determine safety, dosing, and acceptability of long-acting injectable ART with cabotegravir and rilpivirine in adolescents by second quarter of 2024 and children over age 2 years by second quarter of 2024.

281. Continue to support the PAVE Martin Delaney Collaboratory to completion in Q2 2026. The major research goals of the grant includes defining the establishment and evolution of the HIV latent reservoir in perinatal infection and enhancing bNab delivery to achieve post treatment

control of HIV-1 off of ART.

282. Continue to support IMPAACT to complete IMPAACT 2037, which is assessing safety and PK of bNabs in infants exposed to HIV.

283. Support increasing the understanding of concurrent dosing of ARVs and TB medications.

284. When appropriate and unmet needs exist, leverage NIAID resources to support development and evaluation of optimized paediatric formulations for priority ARVs and TB prevention and treatment medications.

285. Contribute to address potential funding gaps for the development of a universal bitter blocker by leveraging contract resources in 2023.

286. Engage in discussions with IAVI and pharmaceutical partners on criteria for advancement of bNAbs for postnatal prophylaxis.

287. Contribute to stakeholder consultations convened by WHO on bNabs for treatment and prevention in 2023.

Updates

279. June 2024: Ongoing. Enrollment completed in Cohort 1C, and PK data are in analysis for interim SMC review.

280. June 2024: Ongoing. Cohort 2 week 24 data in adolescents presented at CROI 2024 as late breaker oral presentation. Accrual started in children 2-< 12 years.

281. June 2024: Ongoing. 

282. June 2024: Enrolment projected to begin Q4 2024/Q1 2025

283. June 2024: Ongoing: NIAID-supported ORCHID study presented data on BID-DTG based ART and Rif-based TB treatment in children 20-35kg and is enrolling children 3-20kg taking 10mg scored dispersible DTG formulation BID and planning to also evaluate QD DTG.

284. 370. June 2024:  Ongoing: Based on an evaluation of the current landscape of TB formulations and specific product gaps, including a discussion with relevant stakeholders (e.g., during PADO-TB2 meeting, October 2023), NIAID has prioritized the development of a pediatric oral dispersible film formulation of Rifapentine for TB prevention. The Target Product Profile and a Product Development Plan are currently being developed with a team of preclinical and clinical experts.

 285. 371. June 2024: NIAID has developed two projects to support early research and development of a potential universal bitter blocker and will be using contract resources to initiate these activities in Q3 2024.

286. June 2024: Ongoing: NIAID represented in IAVI led PNP taskforce.

284. 370. Feb 2024: Based on an evaluation of the current landscape of TB formulations and specific product gaps, including a discussion with relevant stakeholders (e.g., during PADO-TB2 meeting, October 2023), NIAID has prioritized the development of a pediatric oral dispersible film formulation of Rifapentine for TB prevention. The Target Product Profile and a Product Development Plan are currently being developed with a team of preclinical and clinical experts.

279. Feb 2024: Ongoing. Enrollment completed in Cohort 1C, and PK data are in analysis for interim SMC review.

280. Feb 2024: Ongoing. Cohort 2 week 24 data in adolescents presented at CROI 2024 as late breaker oral presentation. Accrual started in children 2-< 12 years.

281. Feb 2024: Ongoing. 

282. Feb 2024: Enrolment projected to begin Q4 2024

283. Feb 2024: Ongoing. NIAID-supported ORCHID study presented data on BID-DTG based ART and Rif-based TB treatment in children 20-35kg and is enrolling children 3-20kg taking 10mg scored dispersible DTG formulation BID and planning to also evaluate QD DTG.

285. 371. Feb 2024: NIAID has developed two projects to support early research and development of a potential universal bitter blocker and will be using contract resources to initiate these activities in Q2-Q3 2024.

286. Feb 2024: Ongoing. NIAID represented in IAVI led PNP taskforce.

TB TREATMENT for CHILDREN, PREGNANT, POST-PARTUM AND BREASTFEEDING WOMEN

NIH/NIAID commits to:

368. Continue supporting IMPAACT and other funded grants to determine PK, safety and dosing of delamanid, bedaquiline, and short course rifapentine by Q4 2025.

369. Support increasing the understanding of concurrent dosing of ARVs and TB medications.

370. When appropriate and unmet needs exist, leverage NIAID resources to support development and evaluation of optimized paediatric formulations for priority ARVs and TB prevention and treatment medications.

371. Contribute to address potential funding gaps for the development of a universal bitter blocker by leveraging contract resources in 2023.

Updates

See above for 370. 371. June 2024

368. June 2024: Ongoing: Protocol IMPAACT P1108 (bedaquiline) has completed accrual. IMPAACT 2005 

(delamanid) is projected to complete accrual in Q3 2024.

369. June 2024: Ongoing: See response for #283

368. Feb 2024: Protocol IMPAACT P1108 (bedaquiline) has completed accrual. IMPAACT 2005 

(delamanid) is projected to complete accrual in Q3 2024.

369. Feb 2024: See response for #283

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