Boehringer Ingelheim, the maker of Viramune (nevirapine), announced that it has begun enrolling participants in a clinical trial of an extended-release formulation of the drug for once-daily dosing. The current formulation of Viramune is approved for use in the U.S. at a dose of 200 mg twice a day. The dose being studied is 400 mg once a day.
The new formulation will be tested in the VERXVE study, which will pair it with Truvada (tenofovir and emtricitabine), and compare it to the current twice-a-day formulation of Viramune, also paired with Truvada. The study will enroll 1,000 patients in 18 countries, who’ve never taken antiretroviral therapy before.
The study will enroll patients throughout 2008, and results are expected in 2010.