2007-05-10 07:03:29 -
INGELHEIM, Germany, May 10 /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
www.boehringer-ingelheim.com/hiv.
Web site: www.boehringer-ingelheim.com/hiv
Source: Boehringer Ingelheim
