HIV TREATMENT
2020
Action 27. Mobilize their networks and work with communities to help build treatment literacy, generate demand, and expand access to ARVs among children.
Action 34. Increase efforts to share information on the roll-out of new paediatric formulations, including lessons learned.
Paediatric HIV & TB : Rome Action Plan
2022 Rome Action Plan on Paediatric HIV & TB
NIAID/NIH
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.
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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.
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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.
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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.
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