BOEHRINGER INGELHEIM ANNOUNCES RESULTS FROM APTIVUS RESIST STUDIES
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. CPIs included lopinavir, saquinavir, amprenavir and indinavir. All patients had baseline genotypic resistance testing prior to randomization to aid investigators in the selection of the CPI/r. Of these highly treatment-experienced patients in the RESIST trials, the majority (86 percent) were at least possibly resistant to the CPI/r chosen.