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Tibotec Pharmaceuticals has announced that two major phase III efficacy trials examining TMC278, its investigational non nucleoside reverse transcriptase inhibitor (NNRTI) for treatment-naÃ¯ve HIV-infected patients, are now fully recruited. Altogether, 379 patients in Europe have entered the studies.
The global trials, which involve 13 European countries, compare the efficacy, safety and tolerability of TMC278 (25 mg) once daily oral tablet versus efavirenz , each co-administered with a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs), in treatment-naÃ¯ve HIV-infected adults. The studies are due to be completed by the first quarter of 2011 and preliminary results will be made available in 2010. Further details about the clinical trials can be found below.
TMC278 is the third anti-HIV compound to be developed by Tibotec, which is also developing other investigational compounds for the treatment of hepatitis C and tuberculosis.
For further information and full press release, visit: Tibotec