The NEAT 001 trial was a phase III, randomised, open-label, multinational, multicenter trial comparing the efficacy and safety of two first-line treatment strategies in antiretroviral naïve HIV-1 infected individuals: darunavir/r + tenofovir/emitricitabine vs. darunavir/r + raltegravir.
In this study, an estimated 800 HIV infected antiretroviral naïve subjects from 15 European countries were enrolled. The treatment period was minimum 96 weeks, and the overall duration of the trial was 3 years. The first patient was enrolled in September 2010. On 5 October 2011 the trial enrolled its last study participant reaching a total of 807 participants randomized into the NEAT001 trial. Follow-up continued until the very last participant in the trial performed the W96 visit.
Copenhagen HIV Programme was one of four regional Clinical Trial Units (CTUs) within the NEAT network. CHIP was responsible for coordinating the trial in Austria, Belgium (French speaking part), Denmark, Germany, Poland, Portugal and Sweden. The overall coordinating CTU is ANRS/U897, Bordeaux, France.
For additional information about the trial please contact CHIP.