Boehringer initiates NEwArT study in HIV patients

The NEwArT 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 200mg of Viramune twice daily or 300mg of atazanavir boosted with 100mg of ritonavir once daily. Patients in the Viramune arm will begin their treatment with 200mg once daily, increased to 200mg 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. The NEwArT trial will enroll 150 HIV-positive patients who have not previously been treated with antiretroviral drugs and results are expected to be available in 2009. Edwin DeJesus, medical director at the Orlando Immunology Center, said: "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."