Boeh Ingl initiates US Viramune study

German drug major Boehringer Ingelheim has begun to enroll HIV patients in the NEwArT study to include 18 planned sites across the USA. The goal of the program is to compare the efficacy and safety of Viramune (nevirapine), a non-nucleoside reverse transcriptase inhibitor versus Bristol-Myer Squibbs' Reyataz (atazanavir), a protease inhibitor boosted with ritonavir.

In the trial, both agents will be combined with the fixed dose combination of tenofovir and Truvada (emtricitabine). The NEwArT study is a Phase IV, open-label, randomized, multicenter evaluation with a primary endpoint of virologic response at 48 weeks, defined as a viral load of under 50 copies/mL at two consecutive visits prior to week 48 and without subsequent rebound or change of antiretroviral therapy by the end of the 48-week period. Secondary endpoints will include an evaluation of change in fasting lipids, noted the firm.