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Tipranavir Phase III Studies and Compassionate Access Program
Reported by Jules Levin
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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. A small Compassionate
Access Program for 150 individuals in the US, Canada and somewhere else (I
forget) is expected to begin in February 2003. A program for 150 individuals
for other geographical areas including Europe will also begin. Unfortunately
these programs are small, but they will provide drug for individuals who do
not qualify for the phase III studies or who are geographically inconvenient
to the phase III studies. A larger Expanded Access Program is planned and is
expected to begin around January 2003. My guess is that FDA approval and
availability in the pharmacy will occur around Fall 2003, perhaps September.
The phase III studies will accomodate individuals with various degrees of PI
resistance including those with extensive PI resistance. An arm of the study
will provide tipranavir plus the low dose ritonavir boost along with another
protease inhibitor to individuals with extensive PI resistance. If you are
interested in participating in the phase III studies or the Compassionate
Access Program, speak to your doctor now. Patients will be able to use T-20
along with tipranavir in the studies and the Compassionate Access Program, if
they can secure T-20. T-20 approval by the FDA is expected early Spring 2003,
but manufacturing capacity and supply is limited. A program of distribution
for the limited supply is in development. Be cautious regarding use of T-20
or tipranavir. You want to select a regimen that will provide fully
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, 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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