Appendix A
Public Committee Meeting Agendas

Committee on Methodological Challenges in HIV Prevention Trials

MEETING ONE

February 6–7, 2007

Washington, DC

February 6, 2007

10:15–10:20 a.m.

Welcome and Overview

Stephen Lagakos, Ph.D. (Chair)

Professor of Biostatistics

Department of Biostatistics

Harvard School of Public Health

10:20–10:35 a.m.

Charge to the Committee

Renee Ridzon, M.D.

Senior Program Officer

HIV, TB, and Reproductive Health

Bill & Melinda Gates Foundation

10:35–11:05 a.m.

Overview of Methodological Challenges in HIV Prevention Trials

Sten Vermund, M.D., Ph.D.

Amos Christie Chair in Global Health

Director, Institute for Global Health

School of Medicine

Vanderbilt University



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Appendix A Public Committee Meeting Agendas Committee on Methodological Challenges in HIV Prevention Trials MEETING ONE February 6–7, 2007 Washington, DC February , 00 10:15–10:20 a.m. Welcome and Overview Stephen Lagakos, Ph.D. (Chair) Professor of Biostatistics Department of Biostatistics Harvard School of Public Health 10:20–10:35 a.m. Charge to the Committee Renee Ridzon, M.D. Senior Program Officer HIV, TB, and Reproductive Health Bill & Melinda Gates Foundation 10:35–11:05 a.m. Overview of Methodological Challenges in HIV Prevention Trials Sten Vermund, M.D., Ph.D. Amos Christie Chair in Global Health Director, Institute for Global Health School of Medicine Vanderbilt University 

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 METHODOLOGICAL CHALLENGES IN HIV PREVENTION TRIALS 11:05–11:20 a.m. Quick Working Group Activities Polly Harrison, Ph.D. Director, Alliance for Microbicide Development 11:20–11:35 a.m. Break 11:35–11:45 a.m. NIH Microbicide Trial Network Sharon Hillier, Ph.D. Director, Reproductive Infectious Disease Research Magee-Womens Hospital Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences University of Pittsburgh 11:45 a.m.–Noon Biomedical Intervention for HIV Prevention Project: The Forum for Collaborative HIV Research Veronica Miller, Ph.D. Director, Forum for Collaborative HIV Research Associate Research Professor The George Washington University Noon–1:00 p.m. Lunch 1:00–1:30 p.m. Incidence Estimation in Microbicide Trials Salim Abdool Karim, M.B.Ch.B., Ph.D. Director, Centre for the AIDS Program of Research in South Africa (CAPRISA) Pro Vice-Chancellor for Research University of KwaZulu-Natal, Durban, South Africa

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 APPENDIX A Late-Stage Microbicide Efficacy Trials 1:30–2:05 p.m. CONRAD: Phase 3 Trial of 6% Cellulose Sulfate Gel and the Effect on Vaginal HIV Transmission (multiple countries, ongoing) FHI: Phase 3 Trial of Cellulose Sulfate Gel to Prevent HIV Infection (Nigeria, ongoing) Doug Taylor, Ph.D. Director of Biostatistics Family Health International (FHI) 2:05–2:35 p.m. Population Council: Phase 3 Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission (South Africa, ongoing) Stephanie Skoler, M.P.H. Study Manager, Microbicides Program Population Council 2:35–3:05 p.m. HPTN 035: Phase II/IIB Safety and Effectiveness Study of Vaginal Micobicides Buffergel and 0.5% PRO2000/5 GEL (P) for the Prevention of HIV in Women (multiple countries, ongoing) Benoît Mâsse, Ph.D. Associate Member, Statistical Center for HIV/AIDS Research & Prevention (SCHARP) Fred Hutchinson Cancer Research Center Affiliate Associate Professor, Biostatistics School of Public Health and Community Medicine University of Washington 3:05–3:25 p.m. FHI: Phase 3 Trial of SAVVY Vaginal Gel to Prevent HIV Infection (Ghana, closed in 2005) FHI: Phase 3 Trial of SAVVY Vaginal Gel to Prevent HIV Infection (Nigeria, closed in 2006)

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 METHODOLOGICAL CHALLENGES IN HIV PREVENTION TRIALS Leigh Peterson, Ph.D. Senior Scientist, Clinical Research Department Family Health International (FHI) 3:25–3:40 p.m. Break 3:40–4:05 p.m. IPM: Phase III Trial of Dapivirine Gel Referred to as IPM 009 (multisite, planned) Zeda Rosenberg, Sc.D. Chief Executive Officer International Partnership for Microbicides (IPM) 4:05–4:25 p.m. CAPRISA: Phase 2/2B trial of Tenofovir/PMPA Gel, Referred to as CAPRISA 004 (South Africa, planned) Salim Abdool Karim, M.B.Ch.B., Ph.D. Pro Vice-Chancellor, Research University of KwaZulu-Natal, Durban, South Africa Director, Centre for the AIDS Program of Research in South Africa (CAPRISA) 4:25–6:00 p.m. Q&A with Microbicide Investigators 6:00 p.m. Adjourn February , 00 8:30–9:00 a.m. MRC: Phase 3 Trial to Evaluate the Efficacy and Safety of 0.5% and 2% PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection (multiple countries, ongoing) Sheena McCormack, M.B.B.S., M.Sc., F.R.C.P. (by conference call) Clinical Epidemiologist Medical Research Council (MRC)

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 APPENDIX A Late-Stage Pre-Exposure Prophylaxis (PrEP) Efficacy Trials 9:00–9:50 a.m. CDC: Phase 3 Safety and Efficacy Trial of Tenofovir Plus Emtricitabine (Truvada) to Prevent HIV Infection (Botswana, planned; TDF trial, closing) CDC: Phase 2/3 Safety and Efficacy Trial of Tenofovir to Prevent HIV Infection (Thailand, ongoing) Dawn Smith, M.D., M.P.H., M.S. Medical Epidemiologist and Acting Associate Branch Chief for Science in the Epidemiology Branch Division of HIV/AIDS Prevention National Center for HIV, STD, and TB Prevention Centers for Disease Control and Prevention (CDC) Ramses Sadek, Ph.D. Lead Mathematical Statistician Division of HIV/AIDS Prevention National Center for HIV, STD, and TB Prevention Centers for Disease Control and Prevention (CDC) 9:50–10:20 a.m. NIH: Phase 3 Safety and Efficacy Trial of Tenofovir Plus Emtricitabine (Truvada) to Prevent HIV Infection (Peru, planned) Robert M. Grant, M.D., M.P.H., M.S. Associate Investigator Gladstone Institute of Virology and Immunology Associate Professor of Medicine University of California, San Francisco David V. Glidden, Ph.D. Associate Professor of Biostatistics University of California, San Francisco 10:20–10:35 a.m. Break

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0 METHODOLOGICAL CHALLENGES IN HIV PREVENTION TRIALS 10:35–10:55 a.m. FHI: Phase 2 Effectiveness and Extended Safety Trial of Tenofovir to Prevent HIV Infection (Ghana, completed; Nigeria and Cameroon, halted) Leigh Peterson, Ph.D. Senior Scientist, Clinical Research Department Family Health International (FHI) 10:55 a.m.–12:20 p.m. Q&A with PrEP Investigators 12:20–12:50 p.m. Community Perspectives Mitchell Warren Executive Director AIDS Vaccine Advocacy Coalition Lori Heise Director Global Campaign for Microbicides 12:50 p.m. Wrap Up and Adjourn MEETING TWO April 19, 2007 London April , 00 8:30–8:40 a.m. Welcome and Overview Stephen Lagakos, Ph.D. (Chair) Professor of Biostatistics Department of Biostatistics Harvard School of Public Health

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 APPENDIX A Issues in Trial Design and Implementation 8:40–9:05 a.m. Site Preparedness and Implementation of Late-Stage HIV Prevention Efficacy Trials in Resource-Limited Settings Gita Ramjee, Ph.D. Director, HIV Prevention Unit South African Medical Research Council 9:05–9:30 a.m. Context, Challenges, and New Ideas for HIV Prevention Trials Helen Rees, O.B.E. Executive Director, Reproductive Health and HIV Research Unit Department of Obstetrics and Gynecology University of the Witwatersrand Johannesburg, South Africa 9:30–9:55 a.m. Accuracy of Self-Reported Sexual Behavior James J. Jaccard, Ph.D. Professor, Department of Psychology Florida International University 9:55–10:10 a.m. Break 10:10–10:35 a.m. Measurement of Adherence, Sexual Behavior, and Product Acceptability in MDP PRO 2000 Microbicide Trial Robert Pool, Ph.D. Senior Lecturer in Social Anthropology London School of Hygiene & Tropical Medicine 10:35–11:00 a.m. Issues in Microbicide Trial Design, Monitoring, and Analysis Andrew Nunn, M.Sc. Associate Director, Clinical Trials Unit United Kingdom Medical Research Council

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 METHODOLOGICAL CHALLENGES IN HIV PREVENTION TRIALS 11:00–11:25 a.m. Microbicide Product Development and Implications for Future Trials Robin Shattock, Ph.D. Reader in Cell Biology of Infection Department of Cellular and Molecular Medicine St. George’s Hospital Medical School University of London 11:25 a.m.–12:15 p.m. Panel Discussion 12:15–1:00 p.m. Lunch Recent Late-Stage Non-Vaccine Biomedical HIV Prevention Trials 1:00–1:25 p.m. Male Circumcision to Prevent HIV Acquisition in Young Men in Kisumu, Kenya Kawango Agot, Ph.D., M.P.H. Coordinator and Coinvestigator, Universities of Nairobi, Illinois, and Manitoba (UNIM) Project Lumumba Health Center University of Nairobi 1:25–1:50 p.m. Male Circumcision to Prevent HIV Acquisition and Transmission in Rakai, Uganda Maria J. Wawer, M.D., M.P.H. Professor, Department of Population, Family, and Reproductive Health Bloomberg School of Public Health Johns Hopkins University 1:50–2:15 p.m. Lessons Learned from STD Treatment Trials for HIV Prevention Maria J. Wawer, M.D., M.P.H. Professor, Department of Population, Family, and Reproductive Health Bloomberg School of Public Health Johns Hopkins University

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 APPENDIX A 2:15–2:40 p.m. Phase 3 Randomized, Placebo-Controlled Trial of HSV-2 Suppression to Prevent HIV Transmission Among HIV-Discordant Couples Connie Celum, M.D., M.P.H. Professor of Medicine and Adjunct Professor of Epidemiology Division of Allergy and Infectious Diseases School of Medicine University of Washington 2:40–3:00 p.m. Break 3:00–4:00 p.m. Panel Discussion 4:00–4:30 p.m. The Latex Diaphragm to Prevent HIV Acquisition Among Women: A Female- Controlled Physical Barrier of the Cervix Nancy Padian, Ph.D., M.P.H. (by conference call) Executive Director, Women’s Global Health Imperative Associate Director of Research, Global Health Sciences Professor, Departments of Obstetrics, Gynecology, and Reproductive Sciences University of California, San Francisco 4:30–5:00 p.m. Key Summary Points and Discussion Kenneth H. Mayer, M.D. Professor of Medicine and Community Health Director, AIDS Program Brown University Attending Physician, Division of Infectious Diseases The Miriam Hospital, Providence, RI Research Medical Director Fenway Community Health, Boston 5:00 p.m. Adjourn