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Boehringer Ingelheim initiates international head-to-head HIV/AIDS trial


Boehringer Ingelheim GmbH announced today that it has initiated and begun enrollment of patients in the ArTEN trial, which will compare the efficacy and safety of Viramune® (nevirapine), a non-nucleoside reverse transcriptase inhibitor (NNRTI), dosed once daily (QD) or twice daily (BID), versus atazanavir/ritonavir, a once-daily dosed protease inhibitor (PI). Both agents will be combined with a background regimen including tenofovir and emtricitabine (Truvada®). The ArTEN trial will enroll 561 HIV-positive patients who have not been treated with antiretrovirals before.

“ArTEN is an important trial. Viramune® dosed twice daily is proven to be an effective, tolerable and durable treatment option with a favourable lipid profile. In ArTEN, Viramune® will be compared with an atazanavir-based regimen. ArTEN may help to provide more information on selecting treatment options for first-line therapy in HIV-positive patients,” said Vicente Soriano, M.D., assistant professor, University Complutense and chief, infectious diseases, Hospital Carlos III, Madrid, Spain.

The ArTEN (Atazanavir/ritonavir on a background of Tenofovir and Emtricitabine (Truvada®) versus Nevirapine) trial is a Phase IIIb, open-label, multinational, randomised, three-arm trial. The primary endpoint is virologic response after 48 weeks of treatment. Treatment response is defined as a viral load of less than 50 copies/mL measured at two consecutive visits prior to week 48 and without subsequent rebound or change of antiretroviral therapy prior to week 48. Patients will be randomised to receive 200 mg of Viramune® BID, 400 mg of Viramune® QD or 300 mg of atazanavir, boosted with 100 mg of ritonavir, with a backbone regimen of tenofovir and emtricitabine (Truvada®). Patients in the Viramune® arm will begin their treatment with 200 mg QD, increased to either 200 mg BID or 400 mg QD after two weeks. Patients will be observed for a period of 48 weeks, with an extension period of up to 144 weeks.

“Viramune® has proven to be a good treatment choice for HIV-positive patients during more than one million patient years of experience and extensive clinical trials,” said Dr. Andreas Barner, Vice-Chairman, Board of Managing Directors and Head of Corporate Board Division Pharma Research, Development and Medicine, Boehringer Ingelheim. “The new ArTEN trial aims to help patients and physicians better understand the role of Viramune® within today’s evolving treatment strategies. We expect ArTEN trial results will be available in 2009.”


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