Center for Drug Evaluation and Research




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.


                                                                                                Division of Antiviral Drug Products



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



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