Tibotec Pharmaceuticals has reported the discontinuation of a single exploratory open-label Phase II study involving TMC125, a non-nucleoside reverse transcriptase inhibitor. Discontinuation of this study has no impact on the Phase III registration studies of TMC125, which are currently enrolling in highly treatment-experienced patients. The trial design, the patient population, the formulation of TMC125 and the background regimen of these trials are substantially different from that of the discontinued study.
The discontinued study involved protease inhibitor-naive patients failing a first line non-nucleoside reverse transcriptase inhibitor-containing regimen. Patients were randomized to receive either TMC125 or a protease inhibitor and the background regimen was limited to two nucleoside reverse transcriptase inhibitors. Data collected after 12 weeks of therapy show that there is a difference in the proportion of patients achieving or maintaining an undetectable viral load in favor of the control group.