ANTIVIRAL DRUGS ADVISORY COMMITTEE
January 11, 2001
Slides
Topic: Discuss clinical trial design issues for patients with HIV-1 infection who have limited therapeutic options (treatment sometimes referred to as "salvage" therapy).
Clinical Trial Design for Heavily Treatment-Experienced Patients, Heidi Jolson, MD, MPH, FDA ppt html
Therapeutic Challenge for Antiretroviral Experienced Patients: A Clinical Perspective, Douglas J Ward, MD ppt html
Overview of Trial Design Options: Adults (Challenges in Clinical Trials in People for Whom Available Therapies have Failed), Martin Schechter, University of British Columbia ppt html
Pediatric Trials for ARV Experienced Children, Coleen K Cunningham ppt html
The Challenges of Clinical Trial Design in Evaluating HIV Antiretroviral Use in Heavily Pre-Treated Patients, The Community Perspective, Carlton Hogan, University of Minnesota ppt html
Summary of Public Response and Regulatory Perspective, Katherine Laessig, MD, FDA ppt html
Response Rates in Heavily Pretreated HIV+ Patients, Roy M Gulick, MD, MPH, Cornell Clinical Trials Unit ppt html
Choice of Endpoints for Salvage Studies, Victor DeGruttola, ScD ppt html