FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ANTIVIRAL DRUGS ADVISORY COMMITTEE (AVAC) MEETING

Draft 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,

(DAVDP), FDA

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

The Urgent Need for an Efficacious University of Natal

Microbicide 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 Contraceptive Research and

Development Program (CONRAD)

Arlington, VA

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 DAVDP, FDA

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

Microbicide Phase 2 and 3 Trial Medical Research Center

Designs, an Investigator’s London, UK

Perspective

9:50 a.m. Questions from the Committee

10:05a.m. Break

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

Topical Microbicide Phase 2 and Chair, Department of Biostatistics

3 Trial Designs, an Investigator’s University of Washington

Perspective Seattle, WA

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

1:45 p.m. Charge to the Committee/ Debra B. Birnkrant, M.D.

Questions for Discussion

5 p.m. Adjourn