What is the NEAT 001 / ANRS 143 Clinical Trial?
NEAT 001 is a strategic trial investigating two different treatment combinations to treat HIV-1 infected patients that have never been treated for their HIV infection before. It compares a standard regimen of three drugs that is already recommended as first-line therapy (regimen for treatment naïve HIV-1 patients ) to an innovative treatment option that combines two potent recent antiretroviral drugs.
NEAT 001 / ANRS 143 is a pan-European Clinical Trial comparing two antiretroviral regimens for the first-line treatment for HIV infected individuals.
The two regimens are: tenofovir/emtricitabine/darunavir, that is likely to become a reference regimen in the next years, and darunavir/raltegravir, an innovative, promising antiretroviral combination.
Eight–hundred HIV+ subjects from 15 European countries are planned to be enrolled in this clinical trial which will last 96 weeks, therefore allowing a long term assessment of the efficacy and safety of the two regimens.
The protocol includes several substudies exploring new aspects of antiretroviral therapy.
Major achievements for NEAT 001 during the reporting period were protocol finalization, budget consolidation, agreement with pharmaceutical companies for free drug supply, regulatory submissions, establishment of standard operating procedures and site selection through five Clinical Trial Units (CTUs).
Spreading of relevant information among HIV+ community is being performed by EATG which is the HIV community partner in the project.
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