Boehringer Ingelheim GmbH
Ute E. Schmidt
Ingelheim, Germany, 05 August 2008 - After careful consideration of the feasibility of meeting the enrolment targets for the SPRING (Safety, efficacy and pharmacokinetics of tipranavir boosted with low dose ritonavir (500mg/200mg) twice daily in 400 racially and gender diverse HIV-positive treatment-experienced population) and TICINO (safety and efficacy of tipranavir/ritonavir in treatment-experienced patients also infected with the hepatitis B or hepatitis C viruses) trials, Boehringer Ingelheim has terminated both studies. These trials have been stopped due to poor enrolment and not to any safety or efficacy reasons. Both the EMEA and the FDA are in agreement with the decision to halt these trials.
SPRING was designed to compare the safety and efficacy of tipranavir/ritonavir in a diverse treatment-experienced male and female population. TICINO was designed to compare the safety and efficacy of tipranavir/ritonavir in treatment-experienced patients also infected with the hepatitis B or hepatitis C viruses.
The success of modern HIV treatments including nevirapine has reduced the number of patients experiencing virologic failure on their earlier regimens and the duration of treatment in any line has increased. This is excellent news for those with HIV, but it also means that the original recruitment goals for the trials, 400 patients for SPRING and a further 200 patients for TICINO, was unfeasible. These 600 patients had to demonstrate previous treatment with at least three classes of HIV therapies and show resistance to more than one protease inhibitor drug. It is estimated that both trials would need to be open for more than 15 years to accrue the patient numbers required in order to have a meaningful result.
Boehringer Ingelheim remains committed to improving HIV therapy by providing physicians and patients with innovative antiretroviral treatment options for early and late treatment lines.
Aptivus® (tipranavir), a non-peptidic protease inhibitor which works by inhibiting the viral protease (an enzyme needed to complete the HIV replication process), remains a valuable option for treatment-experienced patients, helping them achieve and sustain viral undetectability even in patients resistant to multiple protease inhibitors.