Common TitleEMERALD
Official Title A Phase 3, Randomized, Active-controlled, Open-label Study to Evaluate the Efficacy, Safety and Tolerability of Switching to a Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once-daily Single-tablet Regimen Versus Continuing the Current Regimen Consisting of a Boosted Protease Inhibitor (bPI) Combined With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in Virologically-suppressed, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects
Phase Phase III
ClinicalTrials.gov NCT02269917
Treatments
Tenofovir alafenamide-Emtricitabine
, Tenofovir alafenamide-Emtricitabine
Tradename:DescovyOther Names:TAF-FTCClass:Nucleoside Reverse Transcriptase Inhibitors (NRTI)Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine
Tradename:SymtuzaOther Names:DRV-COBI-TAF-FTCClass:Single-Tablet RegimensCategories Treatment-ExperiencedSwitch/Simplification
Funding
IndustryJanssen R & D Ireland
References
- Orkin C, Molina JM, Negredo E, et al. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV. 2018;5:e23-e34.