Tibotec Pharmaceuticals has begun a Phase III clinical trial program for its investigational non-nucleoside reverse transcriptase (NNRTI), TMC125. The program comprises two randomized, placebo-controlled trials in treatment-experienced HIV-1-infected adult patients with documented NNRTI resistance and at least three primary protease mutations. The two clinical trials of 600 patients each will be carried out in 18 countries.
In these studies, the background protease inhibitor (PI) will be Tibotec's investigational PI, TMC114. This trial design will be the first time that two new investigational antiretrovirals have been studied together in combination in heavily treatment-experienced patients.