BI starts enrollment in ArTEN HIV trial

German privately-owned drug firm Boehringer Ingelheim has begun enrollment in a trial of its antiviral Viramune (nevirapine) in HIV infected patients. Specifically, the study will compare the efficacy and safety of once- and twice-daily administration of the drug with the daily protease inhibitor atazanavir/ritonavir in infected individuals who have not previously received antiretroviral therapy.

The program, known as ArTEN, is a Phase IIIb assessment, the primary endpoint of which is defined as virologic response at 48-weeks. In total, the trial will seek to enroll 561 patients who will be randomized to receive one of the three dosing regimens. In addition, all subjects will be provided with background therapy composed of tenofovir and emtricitabine.

Andreas Barner, vice chairman of Boehringer's board of directors, said that Viramune has proved to be a good treatment choice for HIV infected patients, adding that the company has amassed more than one million patient years of experience of the drug from numerous clinical trials (Marketletters passim). He added that the new study, expected to complete in 2009, will help patients and physicians better understand the agent's potential role in continually evolving therapeutic strategies.