CROI 2017 Abstract e-Book

Abstract eBook

Oral Abstracts

ORAL ABSTRACTS

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PROGRAM COMMITTEE WORKSHOP FOR NEW INVESTIGATORS AND TRAINEES Conveners: Serena S. Spudich , Yale Univ, New Haven, USA and JohnW. Mellors , Univ of Pittsburgh, Pittsburgh, PA, USA

Despite extraordinary advances in understanding of the pathogenesis, treatment, and prevention of HIV over the past 35 years, research has fallen short of identifying optimal strategies to provide effective antiretroviral treatment to all infected persons, prevent new infections, limit morbidity in individuals on therapy, and achieve a functional ‘cure.’ The annual Program Committee Workshop for New Investigators and Trainees at the Conference for Retroviruses and Opportunistic Infections (CROI) is designed to develop knowledge and discovery across a broad range of basic and clinical HIV investigation. In this half-day session, Program Committee members will succinctly encapsulate current understanding in five distinct topics, specifically identifying areas of controversy or gaps requiring new investigation and ideas. This year, Dr Paul Bieniasz will start the session by reviewing updated knowledge in the field of molecular virology, including advances in understanding of the viral life cycle and host restriction factors. Dr Richard A. Koup will report on advances in antibodies, from knowledge of existing monoclonal antibodies to progress in antibody engineering, antibody functions, and recent trials employing antibodies for HIV protection and treatment. Dr James A. McIntyre will cover recent advances in HIV prevention, reporting on the ongoing challenges of reaching key and vulnerable populations at high risk of infection, and describing evidence of successful implementation of new biomedical prevention strategies. Dr Judith S. Currier will review non-AIDS complications of HIV infection such as cardiovascular, hepatic, malignant and neurologic disease in the setting of aging, highlighting new insights into the epidemiology, pathogenesis, screening, prevention and treatment of these problems. Finally, Dr Nicolas Chomont will summarize state-of-the-art knowledge regarding HIV reservoirs and the potential for HIV cure, explaining how and where HIV persists during antiretroviral therapy, and describing multiple approaches to HIV eradication or remission, including early treatment strategies, latency reversal, immunotherapies, and host genetic modification. Speakers will highlight key work featured at CROI 2017, and participate in moderated question and answer sessions after each talk to stimulate thought and interactions that enhance the attendees’ experience at CROI. 2 MARTIN DELANEY, PRESENTATION FROM LAB TO LICENSURE: THE IMPORTANCE OF GOOD PARTICIPATORY PRACTICE IN RESEARCH Moderator: Mark Hubbard , Tennessee Association of People with AIDS, Nashville, TN, USA Failure to effectively engage stakeholders has historically resulted in the disruption and closure of a number of large HIV prevention trials. There is a growing body of evidence that engaging stakeholders from the earliest stages of research and concept development and beyond trial site communities can strengthen efficient and ethical conduct of research. In 2007, UNAIDS and AVAC developed Good Participatory Practice (GPP) Guidelines to set global standards for stakeholder engagement throughout the research life cycle of biomedical and related HIV prevention trials. GPP establishes guiding principles and promotes the use of a range of stakeholder advisory mechanisms at all levels to help ensure meaningful, collaborative, transparent, and mutually beneficial relationships. GPP provides a flexible and dynamic roadmap for researchers, sponsors, and implementers. Panelists will provide a brief history of events prior to the development of the GPP guidelines, explain GPP and its fundamental principles as they apply to HIV prevention and cure research, and discuss how the guidelines have helped to shape stakeholder engagement in other fields of medical research. Panelists will explore the practical application of GPP to placebo- controlled clinical trials, open-label PrEP demonstration projects, and social research to guide human studies for HIV cure or long-term remission. Insights and concerns expressed by community members and other stakeholders will inform the discussion throughout. This presentation will inform new investigators and community educators about the critical importance of engaging stakeholders and inspire them to consider the use of GPP principles for all stages and types of research. Panelists Stacey Hannah , AVAC: History and Principles of Good Participatory Practice Guidelines Deborah Baron , Wits Reproductive Health and HIV Institute: GPP as a Guide to Biomedical HIV Prevention Trial Design and Implementation David Evans , Project Inform: Applying GPP Principles to Cure Research. 3 PREVENTION TRIAL DESIGN IN THE ERA OF PREP Deborah J. Donnell, Fred Hutchinson Cancer Rsr Center, Seattle, WA, USA We are at a pivotal moment in HIV prevention where daily oral PrEP has been proven effective, yet is not likely to be fully effective for all populations in need. Further advance of HIV prevention requires the development of vaccines, alternative oral regimens, longer acting or coitally dependent prevention strategies. Clinical trials in HIV prevention lack a surrogate and any efficacy study is a resource-intensive undertaking. This session presents the current designs of clinical trials advancing the pipeline of prevention agents, including the statistical issues surrounding the first active-comparator trials in HIV prevention. As we confront a potential future where highly effective prevention reduces the incidence of HIV-endpoints in prevention trials it is important to begin to consider what evidence would be sufficient to definitively establish evidence of prevention efficacy. 4 IMPLEMENTATION SCIENCE TRIALS: DO THE RULES OF RCTs APPLY? James R. Hargreaves, London Sch of Hygiene and Trop Med, London, United Kingdom Implementation science asks questions about the delivery of interventions to those who need them. Technologies such as drugs, vaccines, or surgical procedures may be the “direct mechanism” of the interventions in question. But implementation science trials answer questions about how best to implement these, about the practice of their delivery, or about the systems through which they are delivered. As such, these trials are inevitably more about human behaviour and system function than they are about the biological efficacy of the drug, vaccine or procedure. This presentation will discuss four implications of this perspective for the design of implementation science trials, illustrating key points with examples. First, such trials are usually most appropriately conducted as cluster-level trials since this is the level at which delivery packages and strategies operate. Second they should be “pragmatic”, as defined in the CONSORT guidance for pragmatic trials. One implication of this is that it is important that they enrol study participants who are representative of the intended target population, rather than opportunistically recruiting selected populations as may be appropriate for individual-level efficacy trials. A further implication of “pragmatism” is that, intervention delivery should be monitored and supervised in a realistic way, not closely controlled to ensure ideal implementation as in efficacy trials. Third, integrated process evaluation, ideally guided by the UK MRC Process Evaluation framework for complex interventions, is an essential component of such trials. This framework emphasises the importance of documenting the implementation of interventions, analysing pathways of change and identifying contextual factors relevant to future policy recommendations about scale-up to other settings. Fourth and finally, owing to lack of investigator control, ethical or other reasons, it may not be feasible to undertake randomisation in some implementation science situations. While a full discussion of the range of design alternatives is beyond the scope of this presentation, I will briefly discuss a framework we have developed to map the most rigorous non-randomised impact evaluation designs against constraints to randomisation often described by practitioners in implementation settings. 5 RESPONDENT DRIVEN SAMPLING AND OTHER METHODS FOR RECRUITING HARD TO REACH POPULATIONS Carl A. Latkin, The Johns Hopkins Univ, Baltimore, MD, USA Reaching and enrolling “hidden” populations for infectious disease prevention, testing, and treatment studies and public health programs remains problematic. Adequate sampling strategies are also need to provide infectious disease modelers with accurate data. Two overlapping approaches to sampling hidden populations are respondent

Oral Abstracts

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CROI 2017