Treatment-naive trial of tipranavir discontinues highest dose arm
Boehringer Ingelheim issued a clinical trial statement on 23 February providing details on the discontinuation of one arm of its trial of tipranavir/r in treatment naive patients.
This followed a recommendation from the Data Safety Monitoring Board (DSMB) for study 1182.33 to close the tipranavir/ritonavir 500 mg/200 mg study arm, based on 48-week safety data. Specifically, the rate of asymptomatic liver enzyme elevations reported in the tipranavir/ritonavir 500 mg/200 mg study arm was higher than in the other study arms and presented a less favorable benefit-risk profile for these treatment-naive patients.
The tipranavir/ritonavir 500 mg/100 mg study arm and lopinavir/ritonavir comparator arm in this trial will continue.
The benefit-risk profile has not changed for the highly treatment-experienced patient population for which tipranavir/ritonavir (500 mg/200 mg) is currently indicated. The rate of asymptomatic liver enzyme elevations in highly treatment-experienced patients in the RESIST clinical trial programme was lower than that observed in the 500 mg/200 mg arm of study 1182.33 in treatment-naive patients.
Source: BI Clinical Trial Statement: Boehringer Ingelheim provides update on study arms of Aptivus (tipranavir) clinical trial in treatment-naive HIV-infected patients. 23 February 2006.