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Methodological Challenges in Biomedical HIV Prevention Trials
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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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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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 Biomedical 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 7, 2007
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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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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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 19, 2007
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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Methodological Challenges in Biomedical HIV Prevention Trials
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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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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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
