Common TitleNEAT001-ANRS 143
Official Title An Open-label Randomised Two-year Trial Comparing Two First-line Regimens in HIV-infected Antiretroviral naïve Subjects: Darunavir/r plus Tenofovir/Emtricitabine vs. Darunavir/r plus Raltegravir (ANRS 143/NEAT 001)
Phase Phase III
ClinicalTrials.gov NCT01066962
Treatments
Darunavir
, Darunavir
Tradename:PrezistaOther Names:DRVClass:Protease Inhibitors (PI)Raltegravir
Raltegravir
Tradename:IsentressOther Names:RALClass:Integrase Inhibitors (INSTI)Categories Treatment-NaiveAdverse EffectsDual TherapyResistance/Virological Failure
Funding
IndustryGilead Sciences, Janssen Pharmaceuticals, Mer
Non-IndustryEuropean Union Sixth Framework Programme, Inserm-ANRS
References
- Bernardino JI, Mocroft A, Mallon PW, et al. Bone mineral density and inflammatory and bone biomarkers after darunavir-ritonavir combined with either raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults with HIV-1: a substudy of the NEAT001/ANRS143 randomised trial. Lancet HIV. 2015;2:e464-73.
- Lambert-Niclot S, George EC, Pozniak A, et al. Antiretroviral resistance at virological failure in the NEAT 001/ANRS 143 trial: raltegravir plus darunavir/ritonavir or tenofovir/emtricitabine plus darunavir/ritonavir as first-line ART. J Antimicrob Chemother. 2016;71:1056-62.
- Raffi F, Babiker AG, Richert L, et al. Ritonavir-boosted darunavir combined with raltegravir or tenofovir-emtricitabine in antiretroviral-naive adults infected with HIV-1: 96 week results from the NEAT001/ANRS143 randomised non-inferiority trial. Lancet. 2014;384:1942-51.