The Challenges of Clinical Trial Design in Evaluating HIV Antiretroviral Use in Heavily Pre-Treated Patients

2/7/01


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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

Author: Lee