The National Institute of Allergy and Infectious Diseases, Division of AIDS (NIAID/DAIDS), in partnership with the Forum for Collaborative Research organized the “Framework for Initiating Pediatric Studies of HIV Cure Interventions: Scientific knowledge gaps, regulatory and ethical considerations” workshop. This workshop, held May 22-23, 2018, in Rockville, Maryland, discussed regulatory pathway strategies for moving promising HIV cure products into pediatric trials.
The workshop brought together investigators in the field of HIV persistence, academics, industry and product developers, ethicists, regulators and community advocates to discuss requirements for prioritizing and accelerating investigation of these products safely and ethically children living with HIV.
Workshop Materials
Presentations
Day 1 - Preliminary SessionsSession I: Setting the Stage - Scientific Background
Landscape of cure interventions and trials in adult populations
Daniel Kuritzkes, Harvard University
Landscape of cure interventions and trials in pediatric populations
Deborah Persaud, Johns Hopkins University
Immune system development in pediatrics
Andrew Prendergast, Queen Mary University of London
Age as a key parameter in anti-infective development: ontogeny informs precision medicine
Ofer Levy, Harvard Medical School
Unique aspects of pediatric immune responses in pediatric HIV cure
Philip Goulder, University of Oxford
Pediatric animal models - predictive ability
Nancy Haigwood, Oregon Health & Science University
Session II: Product Development and Safety Consideration
Industry perspectives on HIV cure research in pediatric populations
James Demarest, ViiV Healthcare
Regulatory perspectives on pediatric HIV cure
Yodit Belew, U. S. Food and Drug Administration
Session III: Ethical Considerations and Community Perspectives
Ethical perspectives on HIV cure research in pediatric populations
Mariana Kruger, Stellenbosch University
Day 2 - Reports from Breakout Groups
Session V: Upcoming pediatric trials of HIV cure interventions
Prime Boost Therapeutic Vaccine Regimen +/- TLR4 agonist for HIV reservoirs in Children
Jintanat Ananworanich, U.S. Military HIV Research Program
IMPAACT Study P1115
Ellen Chadwick, Northwestern University
IMPAACT2008
William Borkowsky, New York University
Dual bNab Treatment in Children
Roger Shapiro, Harvard University
Session VI: Breakout Groups Summary
Breakout Group 1 - The pediatric patient: immunology and response to HIV
Lead Discussants:
Nigel Klein, University College London
Yodit Belew, U.S. Food and Drug Administration
Rapporteur: Adriana Weinberg, University of Colorado Denver
Breakout Group 2 - Approaches to pediatric studies I: Extrapolation of efficacy
Lead Discussants:
Ann Chahroudi, Emory University
Prabha Viswanathan, U.S. Food and Drug Administration
Rapporteur: John Sleasman, Duke University
Elaine Abrams, Columbia University
Kimberly Struble, U.S. Food and Drug Administration
Rapporteur: Louise Kuhn, Columbia University
Breakout Group 4 - Ethical considerations and community perspective
Lead Discussants:
Steven Mphonda, Supporting Operational AIDS Research (Project SOAR)
Liza Dawson, National Institutes of Health
Rapporteur: Anne Coletti, FHI 360