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We conducted a pilot study to determine whether these properties would allow sustained virological suppression after simplification of cART to dolutegravir monotherapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>EARLY-SIMPLIFIED is a randomized, open-label, noninferiority trial. Patients who started cART &amp;lt;180 days after a documented primary HIV-1 infection and had an HIV-1 RNA &amp;lt;50 copies\/mL plasma for at least 48 weeks were randomized (2:1) to monotherapy with dolutegravir 50 mg once daily or to continuation of cART. The primary efficacy endpoint was the proportion of patients with &amp;lt;50 HIV-1 RNA copies\/mL on or before week 48; noninferiority margin 10%.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of the 101 patients randomized, 68 were assigned to simplification to dolutegravir monotherapy and 33 to continuation of cART. At week 48 in the per-protocol population, 67\/67 (100%) had virological response in the dolutegravir monotherapy group vs 32\/32 (100%) in the cART group (difference, 0.00%; 95% confidence interval, \u2013100%, 4.76%). This showed noninferiority of the dolutegravir monotherapy at the prespecified level.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In this pilot study consisting of patients who initiated cART during primary HIV-1 infection and had &amp;lt;50 HIV-1 RNA copies\/mL for at least 48 weeks, monotherapy with once-daily dolutegravir was noninferior to cART. Our results suggest that future simplification studies should use a stratification according to time of HIV infection and start of first cART.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Trials Registration<\/jats:title><jats:p>NCT02551523.<\/jats:p><\/jats:sec>","DOI":"10.1093\/cid\/ciy1131","type":"journal-article","created":{"date-parts":[[2018,12,28]],"date-time":"2018-12-28T20:11:08Z","timestamp":1546027868000},"page":"1489-1497","source":"Crossref","is-referenced-by-count":23,"title":["Noninferiority of Simplified Dolutegravir Monotherapy Compared to Continued Combination Antiretroviral Therapy That Was Initiated During Primary Human Immunodeficiency Virus Infection: A Randomized, Controlled, Multisite, Open-label, Noninferiority Trial"],"prefix":"10.1093","volume":"69","author":[{"given":"Dominique L","family":"Braun","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland"},{"name":"Institute of Medical Virology, University of Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teja","family":"Turk","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland"},{"name":"Institute of Medical Virology, University of Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabian","family":"Tschumi","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland"},{"name":"Institute of Medical Virology, University of Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Grube","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, 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D","family":"Brugger","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Greiner","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Steffens","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cornelia","family":"De Torrent\u00e9-Bayard","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Perrine","family":"Courlet","sequence":"first","affiliation":[{"name":"Service of Clinical Pharmacology, University Hospital Center, University of Lausanne, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathrin","family":"Neumann","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Herbert","family":"Kuster","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus","family":"Flepp","sequence":"first","affiliation":[{"name":"Center of Infectious Diseases Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Bertisch","sequence":"first","affiliation":[{"name":"Checkpoint Zurich, Switzerland"},{"name":"Institute of Global Health, University of Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Decosterd","sequence":"first","affiliation":[{"name":"Service of Clinical Pharmacology, University Hospital Center, University of Lausanne, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00fcrg","family":"B\u00f6ni","sequence":"first","affiliation":[{"name":"Institute of Medical Virology, University of Zurich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karin J","family":"Metzner","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Switzerland"},{"name":"Institute of Medical Virology, 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