Toronto, Canada, 14 August, 2006 – New data on tipranavir oral solution from a Phase II dose finding study in 115 HIV-1 infected children aged 2 to 18 years were announced today at the 16th International AIDS Conference (IAC) in Toronto, Canada. Results from this 48-week analysis show that patients achieved virologic and immunologic improvements when taking tipranavir oral solution combined with ritonavir (tipranavir/r), as part of combination antiretroviral therapy. This study of tipranavir oral solution is the first to evaluate an antiretroviral drug in highly pre-treated HIV-1 infected paediatric patients.

Tipranavir oral solution is an investigational formulation of APTIVUS® (tipranavir). Boehringer Ingelheim plans to submit an application to the European Medicines Agency (EMEA) for tipranavir for an indication in treatment experienced HIV-1 infected paediatric patients in 2007. APTIVUS® received marketing authorisation from the European Commission for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors in October 2005.

“A significant need exists for paediatric formulations of antiretroviral drugs, especially for treatment-experienced children who have limited options for constructing an active and durable treatment regimen,” said Pedro Cahn, M.D., director, Fundación Huesped, Buenos Aires, Argentina. “We now have evidence that tipranavir oral solution, in combination with other antiretroviral medications, may be useful for this paediatric patient population.”

This study shows that HIV-positive children receiving tipranavir/r as part of combination antiretroviral therapy achieved virologic (decrease in viral load to <400 copies/mL or <50 copies/mL) and immunologic (increase in CD4+ cell count) improvements at 48 weeks of therapy. Patients received one of two doses of tipranavir/r (290/115 mg/m2 or 375/150 mg/m2) twice daily. Among patients receiving the lower dose, 39.7% achieved viral loads <400 copies/mL and 34.5% achieved undetectable viral loads <50 copies/mL. With regard to patients taking the 375/150 mg/m2 dose of tipranavir/r, 45.6% achieved viral loads <400 copies/mL and 35.1% achieved undetectable viral loads <50 copies/mL. Treatment with tipranavir/r was associated with a mean CD4+ cell increase of 157 cells/mm3 and96 cells/mm3 in the 290/115 mg/m2 and 375/150 mg/m2 dose groups, respectively.

This study is an international, multi-center, open-label, randomised trial of two doses of tipranavir/r in 115 HIV-positive children. All but three of the children randomised into the trial were treatment-experienced and infected with HIV strains showing high levels of resistance to other antiretroviral drugs. Children were  stratified by age (2 to <6 years, 6 to <12 years, and 12 to 18 years). Fifty-eight children received a 290/115 mg/m2 dose of tipranavir/r twice daily and fifty-seven children received a 375/150 mg/m2 dose of tipranavir/r twice daily. Doses of tipranavir/r for children were based on body surface area (BSA) equivalency to the adult 500 mg/200 mg twice daily dose approved in the EU. The 375/150 mg/m2 dose was selected based on the mean 12-year-old male BSA to allow for higher metabolism in young children.