Materials and Links

Background:

Expanded access programs have been a critical component of HIV drug development that ensures people at late stage HIV disease have early access to new therapies. Most HIV drugs have been made available through expanded access programs while the drug is in phase III clinical studies.

The number of people enrolled in expanded access programs has decreased in recent years. The reason for this is unclear but may be related to: fewer people with advanced stage disease who need early access to an experimental therapy; fewer physicians and sites participating in expanded access programs; physicians and patients prefer to wait until the drug is approved; expanded access programs have opened later in the drug development process.

Objectives:

To have a critical review of past expanded access programs with the goal of improving future expanded access programs so that it meets the needs to patients, physicians, regulatory agencies and the sponsor.

Status:

A roundtable discussion took place on February 16th, 2007 in Washington DC.

The Planning Committee for this project includes:

Rob Camp - TAG
Ben Cheng - Forum for Collaborative HIV Research
Sheldon Fields - ANAC
Joel Gallant - Johns Hopkins
Trip Gulick - Cornell
Michael Horberg - Kaiser Permanente
Bob Huff - TAG
Dan Kuritzkes - Harvard
Randi Leavitt - Merck
Veronica Miller - Forum for Collaborative HIV Research
Kim Struble - FDA
Pablo Tebas - University of Pennsylvania
Randy Tressler - Pfizer