Tibotec initiates recruitment for two Phase III HIV trials

The global trials will compare the efficacy, safety and tolerability of TMC278 (25mg) once daily oral tablet versus efavirenz (EFV), each co-administered with a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs), in treatment-naive HIV-1-infected adults.

The first Phase III, double-blind, randomized study, known as Echo, will evaluate TMC278 (25mg) once daily oral tablet versus EFV (600mg) 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 Thrive, will evaluate TMC278 (25mg) once daily versus EFV (600mg) 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 US, Canada and several countries in Latin America, among others, and will seek to enroll approximately 680 patients. To be eligible, patients must have a viral load greater than 5,000 copies/mL at screening and may not have taken any anti-HIV drugs prior to enrolling, as well as meet other screening criteria.

The primary endpoint of the studies is to assess the proportion of patients with viral load < 50 copies/mL at week 48 on TMC278 versus control. The studies will last for 104 weeks, which includes a four-week screening period, a 96-week treatment period and a four-week follow-up period. Results from both of these studies will be submitted to the FDA for consideration for approval of TMC278.