Boehringer Ingelheim begins Aptivus study in HIV-positive patients.

Boehringer Ingelheim has announced that it has begun the enrolment of patients in its Spring study investigating the administration of Aptivus (tipranavir) in a group of 400 racially diverse HIV-positive treatment-experienced patients in eight countries.

The phase IIIb trial will assess the safety, efficacy and pharmacokinetics of the compound in 200 men and 200 women, being the largest randomised and controlled trial to use therapeutic drug monitoring in this patient group.

Aptivus is a novel non-peptidic protease inhibitor that operates through its inhibition enzymes used in the replication process of HIV and is active against most strains of HIV-1 resistant to existing inhibitors.

It is currently indicated as part of a combination antiretroviral therapy for patients infected with HIV-1 that have been pre-treated with virus resistant to multiple protease inhibitors.

Sharon Walmsley, professor of medicine at the University of Toronto, said: “Clinical trials have shown that the efficacy of antiretroviral treatments may vary across races and genders.”

She added that existing data from the Resist study has shown the efficacy of the compound in HIV-positive, treatment-experienced patients, while this new trial will assess the worth of the drug in a more diverse range of patients.

In November 2006, Boehringer Ingelheim announced the results from two Resist studies showing the improved efficacy of Aptivus as part of a combination antiretroviral treatment compared to a control group of protease inhibitors.