Committee on Methodological Challenges in HIV Prevention Trials
Public Meeting
Washington, D.C.
February 6-7, 2007

AGENDA

Tuesday, February 6, 2007
10:15 – 10:20 a.m.
Welcome and Overview
Steve 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 and 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

11:05 – 11:20 a.m.
Quick Working Group Activities
Polly Harrison, Ph.D.
Director
Alliance for Microbicide Development

11:20 – 11:45 a.m.
NIH Microbicide Trial Network (MTN)
Sharon Hillier, Ph.D.
Director, Reproductive Infectious Disease Research
Magee-Womens Hospital
Professor, University of Pittsburgh, Department of Obstetrics, Gynecology and Reproductive Sciences

11:45 – 12:00 p.m.
Biomedical Intervention for HIV Prevention Project, The Forum for Collaborative HIV Research
Veronica Miller, Ph.D.
Associate Research Professor and Director of the Forum for Collaborative HIV Research,
The George Washington University

12:00 – 1:00 p.m.
LUNCH

1:00 – 1:30 p.m.
Incidence Estimation for Microbicide Trials
Salim Abdool Karim, MBChB, 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)

Late-Stage Microbicide Efficacy Trials

1:30 – 2:05p.m.
CONRAD: Phase III Trial of 6% Cellulose Sulfate Gel and the Effect on Vaginal HIV Transmission
(multiple countries, ongoing)
FHI: Phase III 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 III 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 Microbicides 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 III Trial of SAVVY Vaginal Gel to Prevent HIV Infection (Ghana, closed in 2005)
FHI: Phase III Trial of SAVVY Vaginal Gel to Prevent HIV Infection (Nigeria, closed in 2006)
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, MBChB, 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
Microbicide Investigators

6:00 p.m.
Adjourn

6:00 – 7:00 p.m.
Reception at IOM

Wednesday, February 7, 2007

8:00 – 8:30 a.m.
Continental Breakfast

8:30 – 9:00 a.m.
Medical Research Council (MRC): Phase III 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.
Clinical Epidemiologist
Medical Research Council
(Note: Presenting by Phone)

Late-Stage Pre-exposure Prophylaxis (PrEP) Efficacy Trials

9:00 – 9:50 a.m.
CDC: Phase III Safety and Efficacy Trial of Tenofovir plus Emtricitabine (Truvada) to Prevent HIV Infection (Botswana, planned; TDF trial, closing)
CDC: Phase II/III 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 Centers for Disease Control and Prevention (CDC)
Ramses Sadek, Ph.D., Lead Mathematical Statistician
Division of HIV/AIDS Prevention Centers for Disease Control and Prevention (CDC)

9:50 – 10:20 a.m.
NIH: Phase III 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

10:35 – 10:55 a.m.
FHI: Phase II Effectiveness and Extended Safety trial of Tenofovir to Prevent HIV Infection (Ghana, completed; Nigeria & Cameroon, halted)
Leigh Peterson, Ph.D.
Senior Scientist
Clinical Research Department
Family Health International (FHI)

10:55 – 12:20 p.m.
Q&A with PrEP Investigators
PrEP Investigators

12:20 – 12:50 p.m.
Community Perspectives
Mitchell Warren
Executive Director
AIDS Vaccine Advocacy Coalition (AVAC)

Community Perspectives
Lori Heise
Director
Global Campaign for Microbicides

12:50 – 1:00 p.m.
Wrap up and Adjourn