FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING

Agenda

August 20, 2003

Holiday Inn, Versailles Ballroom, 8120 Wisconsin Avenue, Bethesda, MD 20814

Clinical Trial Design Issues

in the Development of Topical Microbicides

for the Reduction of HIV Transmission

8:00 a.m. Call to Order Roy M. Gulick, M.D., M.P.H.

Chair, AVAC

Introduction of Committee

Conflict of Interest Statement Tara P. Turner, Pharm.D.

Executive Secretary, AVAC

8:15 a.m. Opening Remarks Debra B. Birnkrant, M.D.

Director

Division of Antiviral Drug Products

FDA

8:30 a.m. HIV and STIs in Women: Salim S. Abdool Karim, M.D., Ph.D.

The Urgent Need for an Efficacious Director, Centre for the AIDS

Microbicide Programme of Research in South Africa

University of Natal

Durban, South Africa

8:50 a.m. Lessons Learned from COL-1492, Lut Van Damme, M.D., M.Sc.

a Nonoxynol-9 Vaginal Gel Trial International Clinical Research Manager

Contraceptive Research and Development Program (CONRAD)

Arlington, Virginia

9:10 a.m. Considerations for Topical Teresa C. Wu, M.D., Ph.D.

Microbicide Phase 2 and 3 Trial Medical Officer

Designs, a Regulatory Perspective Division of Antiviral Drug Products

FDA

9:30 a.m. Considerations for Topical Andrew Nunn, M.Sc.

Microbicide Phase 2 and 3 Trial Head, Division Without Portfolio

Designs, an Investigator’s Medical Research Council

Perspective Clinical Trials Unit

London, United Kingdom

9:50 a.m. Questions from the Committee

10:05a.m. Break

10:25 a.m. Statistical Considerations for Thomas R. Fleming, Ph.D.

Topical Microbicide Phase 2 and Professor and Chair

3 Trial Designs, an Investigator’s Department of Biostatistics

Perspective University of Washington

Seattle, Washington

10:50 a.m. Statistical Considerations for Rafia Bhore, Ph.D.

Topical Microbicide Phase 2 and Mathematical Statistician

3 Trial Designs, a Regulatory Division of Biometrics

Perspective FDA

11:15 a.m. Questions from the Committee

12:00 p.m. Lunch

1:00 p.m. Open Public Hearing

2:00 p.m. Charge to the Committee/ Debra B. Birnkrant, M.D.

Questions for Discussion

5:00 p.m. Adjourn