|Re-Thinking the Design of Clinical Trials for the Development of New ARVs|
Re-thinking the Design of Clinical Trials for the Development of New ARVS for Treatment Experienced and Treatment Naïve Patient Populations
Drug development for the treatment of HIV infection has proceeded at an unparalleled pace. The approach that was adopted for clinical development -- including accelerated preliminary approval-- has facilitated the expansion of two drug classes available prior to 1995, to 6 drug classes by the end of 2007. While the palette of drugs from which to construct a regimen is significantly more expansive than it was in the past, the HIV community remains in need of additional new drugs to treat drug resistant virus as well to ensure safety and tolerability for all populations.
It is now time to reconsider our approach to drug development in order to ensure the highest level of safety for patients participating in clinical trials while maintaining an adequate pipeline of new drugs. The goals of the Forum for Collaborative HIV Research Roundtable are to review, discuss and develop consensus in the field of antiviral drug development. These discussions will help to identify the best mechanisms to study drugs for treatment experienced and treatment naïve patients from the US and European perspective.
I. Treatment-Experienced Study Topics
For purposes of discussion, we should define the relevant population for whom designing comparative trials is challenging. In the past (2001) we defined treatment-experience as patients who had a loss or lack of virologic response to at least two HAART regimens that, in total, have included at least one member of each of the approved drug classes (NRTI, NNRTI and PI). In other words, we propose to define the populations based on what they have available to them rather than what they have failed on.
Treatment-Naïve Study Topics
This will be relevant for drugs for which the intent is to obtain an indication for both, treatment naïve and treatment-experienced indication.
The meeting was held on January 10-11, 2008 in Washington DC. A summary of the meeting outcome has been published in AIDS 2008, 22:2419–2427.