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Tipranavir Phase III Studies and Emergency Use Program
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Tipranavir is a new protease inhibitor for patients with resistance to currently available protease inhibitors. Tipranavir will be administered with a low dose of ritonavir to boost levels of tipranavir. Studies so far conducted show tipranavir should be potent and effective for many people with extensive PI resistance. New information about tipranavir will be presented at the annual Retrovirus Conference February 9-14 2003 in Boston.
The pivotol phase III studies for 1300 patients including patients with extensive PI resistance will start in January 2003. An Emergency Use Program for 300 - (150 individuals in the US/Canada & 150 in Europe) is expected to begin in April 2003. The Emergency Use Programs are limited in size due to limited drug supply due to the large size of the phase III studies. However, accessibility to phase III studies appear to be relatively easier than in previous experience with phase III studies due to more liberal study design and entry criteria.
The phase III studies will accommodate individuals with various degrees of PI resistance including those with extensive PI resistance. A companion arm of the study will provide tipranavir plus the low dose ritonavir boost along with another protease inhibitor to individuals with extensive PI resistance. In talking with Boehringer Ingleheim officials, my impression is that company researchers want to provide as much opportunity as possible for access to tipranavir to individuals who screen for the Phase III study. In the phase III study patients not randomized to tipranavir who experience virologic failure (as defined by the study) at eight weeks will have the opportunity to receive tipranavir.
The Emergency Use Program will provide drug for individuals who do not qualify for the phase III studies or who live too far from a Phase III study site. The Emergency Use Program is starting earlier than the emergency use program provided by Abbott for Kaletra a few years ago. Since acquiring tipranavir from Pharmacia, Boehringer Ingleheim has fast tracked the development of tipranavir and is now providing a sizable program of access. These accomplishments are due to a close cooperative effort between the pharmaceutical manufacturer of tipranavir and community leaders, as company officials and researchers have been sensitive to requests from community advocates.
A larger Expanded Access Program is planned and is expected to begin early 2004. . The expected date of approval for tipranavir is 4th quarter 2004.
If you are interested in participating in the phase III studies or the Emergency Use Program, speak to your doctor now. Patients will be able to use T-20 along with tipranavir in the studies and the Emergency Access Program. T-20 approval by the FDA is expected in March 2003, but manufacturing capacity and supply is limited. A program of distribution for the limited supply is in development.
A word of caution. You want to select a regimen that will provide full suppression of HIV, so you can protect the drugs in your regimen by not developing resistance to them. Perhaps both T-20 and tipranavir are needed together to achieve full suppression for an individual patient, and perhaps 3 protease inhibitors (including the low dose ritonavir) are needed along with T-20 to achieve full suppression. You can discuss this with your doctor.
Resistance to tipranavir and it's resistance profile were discussed in a poster at the Resistance Workshop this past Summer 2002, and here is a link to a report on this:
http://www.natap.org/2002/HIVDrugRes/day3.htm
Here is a link to a tipranavir study that included looking at resistance and viral load response, which was presented at the 2002 Retrovirus Conference:
http://www.natap.org/2002/9retro/day21.htm
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