ILF roundtable: Regulatory pathways and clinical trial design for long-acting PrEP
5 March 2018 (By invitation only)

Tenofovir-based HIV pre-exposure prophylaxis (PrEP) is now recognized as a highly effective tool in the HIV prevention toolbox. However, its increasing availability in a number of settings must not prevent the development of new tools, including long-acting PrEP formulations. Indeed, the concomitant use of PrEP by participants in HIV prevention clinical trials can make it challenging to demonstrate the efficacy (non-inferiority) of new tools.

This roundtable reviewed the latest information on PrEP rollout and provided a state-of-the-art overview of the molecules currently under development as long-acting PrEP and in Phase I, II, and III clinical trials. This set the stage for an engaging, interactive discussion of remaining challenges and promising approaches for long-acting PrEP clinical trials and regulatory approval in adults and youth (including neonatal prophylaxis).

Objectives of the meeting

The main objectives for this discussion were to:

  • Provide an update on PrEP R&D, in particular around long-acting PrEP and clinical trial design for regulatory approval in adult and youth populations
  • Provide a multi-stakeholder platform for academia, industry, the community and other stakeholders to exchange on existing and foreseen challenges and potential solutions for the development of long-acting PrEP.

 

Meeting material

  • Related documents
  • Presentations

Welcome
Ken Mayer, The Fenway Institute, IAS Governing Council, United States and Cate Hankins, Amsterdam Institute for Global Health and Development, the Netherlands

Presentation

Opening remarks
Charles Flexner, Johns Hopkins Medicine, ACTG, United States and Mitchell Warren, AVAC, United States

Presentation (C. Flexner) | Presentation (M. Warren)

Update on oral PrEP roll out
Rachel Baggaley, WHO, Switzerland

Presentation

Recent advances in R&D for long-acting PrEP
Myron Cohen, University of North Carolina School of Medicine, HPTN, United States

Presentation

Recent progress in regulatory pathways and clinical trial design for long-acting PrEP: Framing the discussion
Veronica Miller, Forum for Collaborative Research, United States

Presentation

Roundtable discussion:

  • Roundtable discussion I: Long-acting PrEP clinical trials and regulatory approval in adults
    Facilitator: Kimberly Struble, FDA, United States
    Presentation
  • Roundtable discussion II: Long-acting PrEP clinical trials and regulatory approval in youth (including neonatal prophylaxis)
    Facilitator: Bill Kapogiannis, NICHD, United States
    Presentation

Summary and closing comments
Ken Mayer, The Fenway Institute, IAS Governing Counci, United Statesl and Cate Hankins, Amsterdam Institute for Global Health and Development, the Netherlands

Presentation