Tibotec Conducts Two Pivotal Phase III Clinical Trials Studying TMC278 in Treatment-Naive Adult...( - Once-daily TMC278 the third anti-HI...),Health

- Once-daily TMC278, the third anti-HIV compound to be developed in Tibotec

virology portfolio -

YARDLEY, Pa., July 17 /PRNewswire/ -- Tibotec Pharmaceuticals Ltd. announced today that two major phase III efficacy trials examining TMC278, its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), in treatment-naive adults with HIV-1, are now recruiting patients. The global trials will compare the efficacy, safety and tolerability of TMC278 (25 mg) once daily oral tablet versus efavirenz (EFV), each coadministered with a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs), in treatment-naive HIV-1-infected adults.

"Preliminary data have shown TMC278 to be active against HIV for patients who have not previously received treatment," Roger Pomerantz, MD, President of Tibotec Research and Development. "These phase III studies will provide important information on the safety and efficacy of this potential new treatment."

The first phase III, double-blind, randomized study, known as TMC278-C209 or ECHO (Efficacy Comparison in treatment-naive HIV-infected subjects Of TMC278 and EFV), will evaluate TMC278 (25 mg) once daily oral tablet versus EFV (600 mg) once daily, when combined with a fixed background regimen consisting of emtricitabine + tenofovir disoproxil fumarate. A second phase III, double-blind randomized study, known as TMC278-C215 or THRIVE (TMC278 against HIV, in a once daily RegImen Versus Efavirenz), will evaluate TMC278 (25 mg) once daily versus EFV (600 mg) once daily, when combined with an investigator-selected background regimen consisting of two N[t]RTIs (abacavir + lamivudine or tenofovir disoproxil fumarate + emtricitabine or zidovudine + lamivudine).

Each study will be conducted at more than 100 sites in over 20 countries, including the U.S., Canada and several countries in Latin America, among others, and will seek to enroll approximat
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