#AIDS2016 Community Engagement and Ethics in HIV Cure Research Interrupting Antiretroviral Treatment in HIV Cure Research: Scientific and Ethical Considerations THPDD105 S. Garner 1, S. Rennie 2, J. Ananworanich 3, K. Dubé 2, D. Margolis 2, J. Sugarman 4, R. Tressler 1, A. Gilbertson 2, L. Dawson 6 1 Columbus Technologies & Services, Inc., Division of AIDS, NIAID, NIH, Bethesda, United States 2 University of North Carolina at Chapel Hill (UNC), Chapel Hill, United States 3 U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, United States and Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, United States 4 Johns Hopkins University, Baltimore, United States 5 Division of AIDS, NIAID, NIH, Bethesda, United States

#AIDS2016 Basic Ethical Criteria Analytic treatment interruption is being used in HIV ‘cure’ research Raises important scientific and ethical questions Basic ethical criteria: ①A strong scientific justification, including the likelihood of generating valuable information. ②Minimization of risks to study participants. ③A robust informed consent process.

#AIDS2016 ATI: Utility and Risks Scientific utility of ATI: – Current assays have limitations, thus ATI may be critical tool – Currently, ATI may be less useful for eradication studies but is clearly useful for control studies Risks of ATI: – Limited ATI-specific risk information – Expansion of reservoir is a theoretical risk – How much risk can be mitigated by monitoring is unknown These issues deserve further exploration

#AIDS2016 Discussion of Recommendations ATI Justification Participant Selection Study Design and Monitoring Informed Consent Community Engagement and Public Perception Additional Recommendations

#AIDS2016 Acknowledgements Co-Authors – Sam Garner, M. Bioethics – Stuart Rennie, PhD – Jintanat Ananworanich, MD, PhD – Karine Dubé, DrPH – David M. Margolis, MD – Jeremy Sugarman, MD, MPH, MA – Randall Tressler, MD – Adam Gilbertson, DPhil – Liza Dawson, PhD