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Boehringer Ingelheim

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."
About ArTEN
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.
About VIRAMUNE
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
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

Contact:

Judith von Gordon, CD Communications, Boehringer Ingelheim GmbH,
+49-61-32-77-3582, fax: +49-61-32-77-6601

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