1	Topical Microbicides Antiviral Drugs Advisory Committee August 20, 2003
2	Topical Microbicides Definition Drug or biologic product for the reduction of transmission of HIV and/or other STIs, applied topically Varied formulations, +/- device With or without spermicidal activity Vagina or rectum as route of administration prior to intercourse
3	Topical Microbicides Ideal Characteristics Non-irritating Discreet Odorless Tasteless Colorless Stable in most environments Affordable Safe and Effective
4	Topical Microbicides Classes of Drugs Surfactants Buffering agents Chemical barriers Entry inhibitors Nucleoside and non-nucleoside reverse transcriptase inhibitors
5	Adults and Children Estimated to be Living with HIV/AIDS, end of 2002
6	Regional HIV/AIDS Statistics and Features, end of 2002
7	Global Summary of the HIV/AIDS Epidemic, end of 2002
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9	Topical Microbicides Areas of Discussion trial design phase 2/3 run-in vs other designs single trial vs 2 adequate and well controlled trials control arms and criteria of a “win” placebo and no-treatment controls trial duration capture efficacy endpoints, assess durable treatment effect and have long term safety experience
10	Clinical Trial Design Issues in the Development of Topical Microbicides for the Reduction of HIV Transmission 8:30 a.m. HIV and STIs in Women: Salim Karim, MBChB, 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., MSc. 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.D. Microbicide Phase 2 and 3 Trial Medical Research Center Designs, an Investigator’s London, UK Perspective 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, FDA Perspective