Boehringer Ingelheim announces first international head-to-head trial of Aptivus® (tipranavir) versus darunavir in treatment-experienced HIV-positive patients

Boehringer Ingelheim GmbH announced today that enrollment of the POTENT study will begin in August 2007. POTENT will compare the efficacy and safety of Aptivus® (tipranavir) versus darunavir, both with ritonavir as part of combination antiretroviral therapy. POTENT will include 800 treatment-experienced patients in 15 countries. The primary endpoint is time to virologic failure, with a secondary endpoint of virologic response at 48 weeks of treatment.

In the ongoing RESIST trials, Aptivus demonstrated superior virologic and immunologic responses versus a comparator group of protease inhibitors in highly treatment-experienced patients through 96 weeks of therapy.1 The POTENT study will be the first head-to-head study comparing Aptivus to another protease inhibitor developed specifically for treatment-experienced patients with HIV resistant to multiple agents in the protease inhibitor class.

“Treatment-experienced patients need active treatment options to help achieve and maintain undetectable viral load. Tipranavir and darunavir are important antiretroviral agents for these patients and there is much to learn regarding their respective roles in treatment. POTENT is an important study because it will help provide physicians and patients with this information to guide future treatment choices,” said Laurent Cotte, M.D., Hepatology/AIDS Unit, Hotel-Dieu Hospital, Lyon, France.

The POTENT (PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in Treatment Experienced Patients) study will be a Phase IV, open-label, multinational, randomised study of patients previously treated with three classes of antiretrovirals, with a minimum of three months duration in each class, and documented resistance to more than one protease inhibitor. Virologic response will be defined as viral load of less than 50 copies/mL. Patients will be randomised to receive 500 mg of Aptivus boosted with 200 mg of ritonavir twice daily or 600mg of darunavir boosted with 100 mg of ritonavir twice daily. Both agents will be administered with an optimized background regimen, which may include certain investigational agents. Patients will be observed for a period of 48 weeks.

“Boehringer Ingelheim is committed to the ongoing study of Aptivus, and anticipates that POTENT will reinforce the therapeutic benefits of Aptivus for HIV-positive treatment-experienced patients. We expect results from the study will be available in 2010,” said Dr. Andreas Barner, Vice-Chairman, Board of Managing Directors and Head of Corporate Board Division Pharma Research, Development and Medicine, Boehringer Ingelheim.

POTENT
The POTENT study will enroll 800 patients in more than 150 sites across 15 countries. HIV-1 infected male and female patients aged 18 years and older will have been on their current failing protease inhibitor-containing regimen for at least 8 weeks, will have a CD4+ cell count of ≥50 cells/mm³ and a viral load count of ≥1000 copies/mL. Patients who have had a prior AIDS-defining event will be eligible as long as the event has resolved for at least twelve weeks before screening, excepting patients with a history of progressive multifocal leukoencephalopathy, visceral Kaposi`s sarcoma, and/or any malignancy.