BACKGROUND:

Currently, with over 30 drugs on the market - some in the form of drug combinations in a single pill - developers of new ARVs are faced with a dilemma: how to assess the contribution of an investigational HIV agent in the presence of a fully suppressive optimized background regimen (OBR).

The September 30th, 2010 roundtable was the 4th in the series organized by Forum and co-convened with FDA to address this dilemma. Meeting participants included representatives from regulatory agencies, academia, community physicians, and patient advocates.

OBJECTIVES:

1. To discuss general developments with non-inferiority margins and adaptive design in clinical trials and regulatory experience

2. To provide perspectives on recent clinical trial experiences with investigational HIV agents

3. To propose new models to study investigational HIV agents in clinical trials and discuss possible solutions to commonly encountered issues in clinical trials

4. To discuss the need for trials in treatment naïve patients, dose-finding and identification of biomarkers for longer term safety evaluations

STATUS:

The meeting was held on Thursday, September 30, 2010 at UC Washington Center, Washington DC.  

UPDATE: The summary outcome titled "Novel Clinical Trial Designs for the Development of New Antiretroviral Agents” has been published electronically in AIDS, 2012.  To access the publication, click here.

STEERING COMMITTEE:

• Eoin Coakley Monogram Biosciences
• Nikos Dedes European AIDS Treatment Group
• Roy Gulick Weill-Cornell Medical Center
• Robert Huff AIDS Treatment Activists Coalition
• Filip Josephson EMA
• Veronica Miller FCHR
• Nathalie Morgenztejn EMA
• Sandra Palleja Tobira Therapeutics
• Jur Strobos FCHR
• Kim StrubleFDA
• Stefano Vella Istituto Superiore di Sanita, Rome

UPDATE: March 11, 2011
Letter in support of the new HIV clinical trial paradigm for a “two-part hybrid” proposal for treatment-experienced patients has been signed by academics and community representatives and submitted to the FDA. Read the letter here.