ANTIVIRAL DRUGS ADVISORY COMMITTEE
November 2, 1999
Slides
HIV-1 Resistance Testing in Drug Development, Heidi Jolson, MD ppt htm
SESSION 1-Performance Characteristics and Limitations of Currently Available Genotypic and Phenotypic Assays
Session 1 - Performance Characteristics and Limitations of Currently Available Genotypic and Phenotypic Assays, Lauren Iacono-Connors, PhD, FDA ppt htm
Principles of HIV resistance testing and overview of assay performance characteristics -- Douglas Richman, MD, University of California San Diego and San Diego VA Medical Center
CBER's Policies on Assay Regulation: Definitions of Assay Performance Characteristics, Andrew Dayton, MD, PhD, FDA ppt htm
SESSION 2-Evaluation of Relationships between Genotype, Phenotype and Treatment Outcome
Introduction: Girish Aras, PhD, FDA ppt htm
VIRADAPT Study: Phillipe Clevenbergh, MD, Department of Infectious Disease, ARCHET Hospital, Nice, France ppt htm
GART Study: John Baxter, MD, Cooper Hospital , Robert Wood Johnson Medical School, New Jersey ppt htm
Introduction to Resistance Collaborative Group's (RCG) re-analysis of selected studies using the RCG Data Analysis Plan (DAP), John Mellors, MD, University of Pittsburgh Medical Center ppt htm
DAP Statistical Methodology: Victor DeGruttola ScD, Harvard School of Public Health ppt htm
ACTG 333: Michael Para, MD, University Hopspital Clinic ppt htm
CNAA2007: Mounir Ait-Khaled, PhD, Glaxo Wellcome ppt htm
Frankfurt cohort: Veronica Miller, PhD, Klinikum der JW Goethe Universitat, Frankfurt, Germany ppt htm
Summary of Studies Analyzed by DAP: FDA Statistical Comments, Girish Aras, PhD, FDA ppt htm