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Boehringer Ingelheim Initiates NEwArT Study Comparing Viramune(R) (nevirapine) to a Ritonavir-Boosted Atazanavir-based Regimen in Treatment-Naive HIV Patients
Date:11/28/2007

ents will also receive the fixed dose combination of tenofovir and emtricitabine. Patients will be treated for up to 48 weeks.

NEwArT trial results are expected to be available in 2009.

About NEwArT

The NEwArT study will enroll antiretroviral-naove HIV-1 infected male and female patients 18 years and older. At screening, male patients must have a CD4+ cell count of <400 cells/mm3 and female patients must have a CD4+ cell count of <250 cells/mm3. Patients will have no prior NRTI or NNRTI use of more than 10 days and no prior use of other classes of antiretrovirals of more than two weeks duration.

For additional information on inclusion and exclusion criteria and NEwArT study sites, visit http://www.clinicaltrials.gov.

About VIRAMUNE

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 two smaller supportive studies.

Life-threatening and fatal hepatotoxicity has occurred in patients receiving VIRAMUNE. Any patient can experience hepatic events; however, female gender and higher CD4+ counts at initiation of therapy place patients at greater risk. Women, including pregnant women, with CD4+ cell counts >250 cells/mm3 are at the greatest risk. 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. Hepatic events are often associated with rash.

Life-threatening and fatal skin reactions have also occurred, including Stevens-Johnson Syndrome, toxic epidermal necrolysis and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction.

Patients should be intensively monitored for hepatic and skin reactio
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
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