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BOEHRINGER INGELHEIM ANNOUNCES RESULTS FROM APTIVUS STUDY

November 21, 2005

Boehringer Ingelheim has reported new data on Aptivus (tipranavir) capsules from a 48-week combined analysis of the RESIST-1 and RESIST-2 studies.

The RESIST trials are randomized, controlled, open-label Phase III trials designed to study Aptivus combined with ritonavir (Aptivus/r) versus a group of ritonavir-boosted comparator protease inhibitors (CPI/r) in patients previously treated with all three classes of antiretroviral agents. Patients enrolled in the RESIST studies had received at least two previous PI-based regimens and were failing a PI-based regimen at the time of study entry.

Aptivus/r and the ritonavir-boosted comparator PIs were taken in conjunction with other anti-HIV agents as part of combination antiretroviral therapy. All patients had baseline genotypic resistance testing prior to randomization. Of these highly treatment-experienced patients in the RESIST trials, the majority (86 percent) were at least possibly resistant to the CPI/r chosen.