January 11, 2001


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