DESIGN APPROACHES FOR CURRENT AND FUTURE HIV PREVENTION EFFICACY TRIALS

VIRTUAL WORKSHOP SERIES

OCTOBER 2020 TO JANUARY 2021

Online content available from 16 October 2020

First online event on 27 October 2020

#HIVPxTrialDesign

Hosted by The Global HIV Vaccine Enterprise in partnership with the HIV Vaccine Trials Network, the HIV Prevention Trials Network and the Forum for Collaborative Research.

HIV prevention is evolving rapidly with the roll out of new tools such as pre-exposure prophylaxis (PrEP) and treatment as prevention making a significant contribution towards controlling the epidemic. As a result, the design and conduct of the next generation of prevention trials is impacted and is further affected by the outcomes of ongoing HIV prevention efficacy trials – including oral and injectable antiretrovirals, passively infused monoclonal antibodies, and HIV vaccines.

This series of virtual workshop aims to continue from the first HIV Prevention Efficacy Trial Designs of the Future symposium, held in November 2018 in Seattle by the Fred Hutch and the NIAID, which led to a series of articles published in Statistical Communications in Infectious Diseases and a viewpoint in The Lancet HIV.

Participants will reflect on more recent advances and challenges within the HIV prevention field and on the rationale and lessons learned for current HIV prevention designs. They will examine novel scientific approaches for establishing efficacy of new biologics in a future where all trial participants have access to effective prevention.

Introduction to the workshop (s1-01)

Roger Tatoud, Ph.D.
Deputy Director, HIV Programmes and Advocacy
International AIDS Society, Geneva, Switzerland

Setting the Stage (S1-02)

Linda-Gail Bekker, MBChB, DTMH, DCH, FCP(SA)
Director
Desmond Tutu HIV Centre, Cape Town, South Africa.

This series of virtual events includes pre-recorded presentations available seven to ten days before live panel sessions. Two sets of bite-size presentations will be available and participants will be able to ask questions to the panel ahead of time using a dedicated website.

DateEvent
Friday 16 OctoberSession 1 pre-recordings available
Tuesday 27 OctoberLive session 1: Current efficacy trial design approaches – Challenges and lessons learned
Session 2 pre-recordings available
Friday 6 NovemberLive session 2A: Future design approaches for settings where all participants are on active prevention – ARV based prevention
Wednesday 18 NovemberLive session 2B: Future design approaches for settings where all participants are on active prevention – Vaccines
January 2021Live session 2C: Future design approaches for settings where all participants are on active prevention – Monoclonal antibodies
January 2021Live Session 3
Panel Discussion 3A: Investigation of methodological issues
Panel Discussion 3B: Community engagement and involvement in clinical research
Regulatory forum organized by the Forum for Collaborative research

For further information on similar initiatives:

The forum HIV prevention trial design public meetings series

The Forum HIV Prevention Trial Design Project will convene a series of public meetings to offer the community a powerful opportunity to review and discuss strategies together with all stakeholders to allow for less resource-intensive clinical trial options for new PrEP interventions’ approval while maintaining scientific rigor.

Designing a New Generation of HIV Prevention Efficacy Trials

Bill Snow, AVAC co-founder and senior advisor, explores the design and implementation of clinical trials.

For further information on HIV vaccine trials:

Visit AVAC which offers a rich gallery of infographics on current biomedical interventions and vaccines.

Organizing Committee

Deborah Donnell, Ph.D.

Professor, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center
Affiliate professor, Department of Global Health and Outcomes Research, University of Washington
Seattle, USA.

Holly Janes, Ph.D.

Professor, Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center
Affiliate professor, Department of Biostatistics, University of Washington
Seattle, USA.

Veronica Miller, PhD

Adjunct Professor, University of California Berkeley
Executive Director Forum for Collaborative Research
Berkeley, USA

Stephaun E. Wallace, Ph.D., M.S.

Director of External Relations, HIV Vaccine Trials Network
Staff Scientist, Vaccine and Infectious Disease Division, Fred Hutch
Clinical Assistant Professor, Department of Global Health, University of Washington
Seattle, USA.

Linda-Gail Bekker, MBChB DTMH DCH FCP (SA) PhD

Deputy director of the Desmond Tutu HIV Centre at the Institute of Infectious Disease and Molecular Medicine at the University of Cape Town (UCT) and chief operating officer of the Desmond Tutu HIV Foundation. Cape Town, South Africa.

Holly Prudden, Ph.D.

Project Manager (Vaccines), HIV Programmes and Advocacy
International AIDS society, Geneva, Switzerland.

Roger Tatoud, Ph.D.

Deputy Director, HIV Programmes and Advocacy
International AIDS society, Geneva, Switzerland.

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