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"The NEwArT trial may help patients and physicians better understand therole of nevirapine within today's evolving treatment strategies and providemore information on selecting treatment options for first-line therapy inHIV-positive patients," explained lead study investigator Edwin DeJesus, M.D.,medical director of the Orlando Immunology Center.
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The NEwArT (efficacy and safety of NEvirapine compared With Atazanavirboosted with Ritonavir and a background of Truvada in HIV-1 infected patientswho have received no previous antiretroviral treatment) study is a Phase IV,open-label, randomized, multicenter trial with a primary endpoint of virologicresponse at 48 weeks, defined as a viral load <50 copies/mL at two consecutivevisits prior to Week 48 and without subsequent rebound or change ofantiretroviral therapy by Week 48. Secondary endpoints will include anevaluation of change in fasting lipids.
Patients will be randomized to receive either 200 mg of VIRAMUNE twicedaily 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 dailyincreased 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 willalso 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 andfemale patients 18 years and older. At screening, male patients must have aCD4+ cell count of <400 cells/mm3 and female patients must have a CD4+ cellcount of <250 cells/mm3. Patients will have no prior NRTI or NNRTI use of morethan 10 days and no prior use of other classes of antiretrovirals of more thantwo weeks duration.
For additional information on inclusion and exclusion criteria and NEwArTstudy sites, visit www.clinicaltrials.gov.
About VIRAMUNE
VIRAMUNE is indicated for use in combination with other antiretroviralagents for the treatment of HIV-1 infection. This indication is based on oneprincipal clinical trial that demonstrated prolonged suppression of HIV-RNAand two smaller supportive studies.
Life-threatening and fatal hepatotoxicity has occurred in patientsreceiving VIRAMUNE. Any patient can experience hepatic events; however, femalegender and higher CD4+ counts at initiation of therapy place patients atgreater risk. Women, including pregnant women, with CD4+ cell counts >250cells/mm3 are at the greatest risk. VIRAMUNE should not be initiated in adultfemales with CD4+ cell counts greater than 250 cells/mm3 or in adult maleswith CD4+ cell counts greater than 400 cells/mm3 unless the benefit outweighsthe risk. Hepatic events are often associated with rash.
Life-threatening and fatal skin reactions have also occurred, includingStevens-Johnson Syndrome, toxic epidermal necrolysis and hypersensitivityreactions characterized by rash, constitutional findings, and organdysfunction.
Patients should be intensively monitored for hepatic and skin reactionsfor the first 18 weeks of therapy with extra vi
