Boehringer Ingelheim Initiates NEwArT Study Comparing Viramune (nevirapine) to a Ritonavir-Boosted Atazanavir-based Regimen in Treatment-Naive HIV Patients
RIDGEFIELD, Conn., November 28, 2007 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc., makers of Viramune(R) (nevirapine) tablets, announced today that it has begun to enroll patients in the NEwArT study to include 18 planned sites across the United States. The goal of the NEwArT study is to compare the efficacy and safety of VIRAMUNE, a non-nucleoside reverse transcriptase inhibitor (NNRTI) versus atazanavir, a protease inhibitor (PI) boosted with ritonavir. Both agents will be combined with the fixed dose combination of tenofovir and emtricitabine (Truvada(R)). The NEwArT trial will enroll 150 HIV-positive patients who have not previously been treated with antiretroviral drugs.
"The NEwArT trial may help patients and physicians better understand the role of nevirapine within today's evolving treatment strategies and provide more information on selecting treatment options for first-line therapy in HIV-positive patients," explained lead study investigator Edwin DeJesus, M.D., medical director of the Orlando Immunology Center.
The NEwArT (efficacy and safety of NEvirapine compared With Atazanavir boosted with Ritonavir and a background of Truvada in HIV-1 infected patients who have received no previous antiretroviral treatment) study is a Phase IV, open-label, randomized, multicenter trial with a primary endpoint of virologic response at 48 weeks, defined as a viral load <50 copies/mL at two consecutive visits prior to Week 48 and without subsequent rebound or change of antiretroviral therapy by Week 48. Secondary endpoints will include an evaluation of change in fasting lipids.
Patients will be randomized to receive either 200 mg of VIRAMUNE twice daily or 300 mg of atazanavir boosted with 100 mg of ritonavir once daily. Patients in the VIRAMUNE arm will begin their treatment with 200 mg once daily increased to 200 mg twice daily after two weeks. The current VIRAMUNE CD4+ cell criteria are being applied to both arms of the study. All patients 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.
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 www.clinicaltrials.gov.
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 reactions for the first 18 weeks of therapy with extra vigilance during the first 6 weeks, which is the period of greatest risk. Frequent monitoring should be performed throughout therapy with VIRAMUNE.
VIRAMUNE should be discontinued and not restarted in patients who develop signs or symptoms of hepatitis, hypersensitivity or severe skin reactions. In some cases, hepatic injury has progressed despite discontinuation of treatment. Other common side effects include nausea, fatigue, fever, headache, vomiting, diarrhea, abdominal pain, and myalgia. Immune reconstitution syndrome has been reported in patients treated with combination ARV therapy.
Please see full Prescribing Information, including boxed WARNING, for VIRAMUNE at www.VIRAMUNE.com.
About Boehringer Ingelheim
Boehringer Ingelheim is committed to improving HIV therapy by providing physicians and patients with innovative antiretroviral agents.
For more information on Boehringer Ingelheim Pharmaceuticals, Inc., please visit http://us.boehringer-ingelheim.com.
CONTACT: Ann Wainright, Associate Director, Public Relations, BoehringerIngelheim Pharmaceuticals, Inc., +1-203-791-6318, Fax, +1-203-791-6442 or firstname.lastname@example.org
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Posted: November 2007