Tipranavir Expanded Access Program

A long-awaited expanded access program for the new protease inhibitor tipranavir should make it available for 3,000-5,000 people starting in mid-to-late November. The main advantage of tipranavir is that it appears to remain active to some degree even in people whose virus has developed resistance to multiple protease inhibitors. Studies in people with multi-drug resistance have shown considerable success.

When used by itself, tipranavir is poorly retained in the body and must be boosted with 400 mg daily of ritonavir. This is two to four times as much ritonavir as other protease inhibitors require. Tipranavir will be free during the expanded access program (through Boeringher-Ingelheim), as well as the requisite ritonavir boost (available from Abbott Labs' Patient Assistance Program at 1-800-222-6885). Tipranavir is made by Boeringher-Ingelheim; ritonavir by Abbott Labs.

Details: The tipranavir program will not require people to have any particular CD4+ cell count level or viral load. To qualify, people must meet the following:

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• Previously used three classes of anti-HIV drugs, such as NRTIs, NNRTIs and protease inhibitors

• Failed at least two protease inhibitor-based regimens

• Must have documented resistance to multiple protease inhibitors

While on the tipranavir regimen, people may not use any protease inhibitor other than ritonavir or any other experimental (not yet FDA approved) compound.

When the program is announced, an 800 number will be provided through which any physician can register people for the program. Call Project Inform's Hotline for more information once the program begins.

Back to the Project Inform Perspective November 2004 contents page.