Table of Contents
The Challenges of Clinical Trial Design in Evaluating HIV Antiretroviral Use in Heavily Pre-Treated Patients
Who is a “Salvage Patient”?
Coalition for Salvage Therapy
Intensification Designs
Monotherapy/”Virtual” Monotherapy
Concentration Controlled Trials
Open questions
Open Questions II
Trial Design Priorities
True Salvage Patients
Designs for the True Salvage Patient
Background Therapy in Salvage Trials
The “Factorial on Top of Optimized Background Therapy” concept
Better Yet
The Consensus Favorite
Advantages and Disadvantages
Endpoints
What We Need From the Agency
What We Need From the Agency
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