NEAT 001

• Research type

  Research Study

• Full title

  An open label randomised two-year trial comparing two first-line regimens in HIV-infected antiretroviral naive subjects: darunavir/r + tenofovir/emtricitabine vs. darunavir/r + raltegravir

• IRAS ID

  36198

• Contact name

  Nick Paton

• Sponsor organisation

  Agence nationale de recherche sur le sida et les hépatites virales (ANRS)

• Eudract number

  2009-015113-44

• Clinicaltrials.gov Identifier

  NCT01066962

• Research summary

  The NEAT 001 study is designed to compare the efficacy and safety of two different combinations of antiretroviral drugs in adults with HIV who have never taken drugs to treat their HIV infection. The two treatment strategies that are being compared are: Group 1: darunavir/ritonavir + tenofovir/emtricitabine This is a treatment strategy combining three different drugs: one protease inhibitor (PI) boosted with a small dose of ritonavir and two nucleoside reverse transcriptase inhibitors (NRTIs) and Group 2: darunavir/ritonavir + raltegravir This is a new treatment strategy combining two drugs: a protease inhibitor (darunavir) boosted with a small dose of ritonavir, and a new class of drugs (integrase inhibitor raltegravir). Eight hundred participants will be enrolled in the study. Patients will be screened for eligibility. If eligible, following randomisation patients will receive their treatment for a minimum of 96 weeks, with all patients remaining in the trial until the last patient enrolled has completed the week 96 visit. Patients will attend approximately 8 study visits in the first year of the study and then at 4 monthly intervals, at which the study staff will assess the safety and effectiveness of the drug, and include taking a sample of blood and/or urine. The main objectives of the study are to access the time to virologic or clinical failure (e.g. disease progression, severe non AIDS defining events, death).

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  10/H1306/15

• Date of REC Opinion

  29 Jun 2010

• REC opinion

  Further Information Favourable Opinion