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Boehringer Ingelheim Initiates International Head-to-Head HIV/AIDS Trial
Ingelheim, Germany (ots/PRNewswire) -
- Trial to Compare Efficacy and Safety of Viramune(R) (Nevirapine) Versus Atazanavir/Ritonavir in Treatment-Naive Patients
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(R) (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(R)). 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."
The ArTEN trial will enroll patients in 83 sites across Argentina, Germany, Italy, Mexico, Poland, Portugal, Romania, Spain, Switzerland and the United Kingdom. HIV-1 infected male and female patients 18 years and older will have positive serology (ELISA) confirmed by Western blot and be antiretroviral-naive. At screening, male patients will have a CD4+ cell count of <400 cells/mm3 and female patients will have a CD4+ cell count of <250 cells/mm3. Patients who have had a prior AIDS-defining event will be accepted as long as the event has resolved or the patient has been on stable treatment for at least twelve weeks before screening.
VIRAMUNE is a product of original research done at Boehringer Ingelheim. VIRAMUNE was the first member of the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of anti-HIV drugs. VIRAMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principal clinical trial that demonstrated prolonged suppression of HIV-RNA and several smaller supportive studies. Studies have also shown that patients switching to VIRAMUNE from a PI-based regimen demonstrate an improved lipid profile while maintaining viral suppression. The most clinically important adverse events associated with VIRAMUNE are rash and hepatic events, which have included fatal cases. Any patient can experience hepatic events; however, female gender and higher CD4+ cell counts at initiation of therapy place patients at greater risk. Women with CD4+ cell counts >250 cells/mm3 are at the greatest risk. By application of the VIRAMUNE CD4+ guidelines the risk of hepatic events can be dramatically reduced. VIRAMUNE should not be initiated in adult females with CD4+ cell counts greater than 250 cells/mm3 or in adult males with CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk. The greatest risk of severe rash and hepatic events occurs in the first six weeks of therapy. It is essential that patients be monitored for these reactions at all times, and intensively during the first few months of therapy. VIRAMUNE should be discontinued and not restarted following severe hepatic, skin or hypersensitivity reactions.
Boehringer Ingelheim is committed to the research and development of novel antiretroviral agents. Apart from Viramune(R) (nevirapine), Aptivus(R) (tipranavir) is a new non-peptidic protease inhibitor, approved for combination antiretroviral treatment of HIV-1 infected adults that are highly pre-treated with virus resistant to multiple protease inhibitors. The company is committed to improving HIV therapy by providing physicians and patients with innovative antiretrovirals.
For more information on Boehringer Ingelheim, please see http://www.boehringer-ingelheim.com/hiv.
Web site: http://www.boehringer-ingelheim.com/hiv
ots Originaltext: Boehringer Ingelheim
Im Internet recherchierbar: http://www.presseportal.ch
Judith von Gordon, CD Communications, Boehringer Ingelheim GmbH,
+49-61-32-77-3582, fax: +49-61-32-77-6601