Dolutegravir
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | TIVICAY PD | — | 2021-07-09 | fda.gov ↗ |
| Label expansions (6) | US (FDA) | TIVICAY | — | 2014-12-19 – 2020-06-12 | fda.gov ↗ |
| Approved | EU (EMA) | Tivicay | — | 2014-01-16 | europa.eu ↗ |
| Approved | US (FDA) | TIVICAY | — | 2013-08-12 | fda.gov ↗ |
Trials 206 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT05030025 | Aug 2021 | HIV infectious disease | Mylan Inc. | Completed | No outcome recorded |
| Phase 0 | NCT04302896 | Aug 2020 → Sep 2021 | HIV infectious disease | Rhonda Brand | Completed | No outcome recorded |
| Phase 162 trials | ||||||
| Phase 1 | NCT07532304 | May → Jul 2026 overdue | — | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06281834 | Nov 2024 → Feb 2027 expected | latent tuberculosis infection | Brigham and Women's Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT05489406 | Oct 2022 → Mar 2023 | HIV infectious disease | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT05406583 | Oct 2022 → Mar 2025 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT04771754 | Mar 2022 → Dec 2023 | — | Chelsea and Westminster NHS Foundation Trust | Completed | No outcome recorded |
| Phase 1 | NCT05236530 | Mar → Oct 2022 | malaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT07002229 | Dec 2021 → Feb 2022 | — | Henan Genuine Biotech Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04827134 | May → Jul 2021 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT04147715 | Oct 2019 → Sep 2020 | — | Shionogi | Completed | No outcome recorded |
| Phase 1 | NCT03984838 | Jun → Aug 2019 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT03921723 | May → Jul 2019 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02437110 | Apr 2019 → Nov 2022 | amyotrophic lateral sclerosis | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 1 | NCT03816696 | Jan → Mar 2019 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT03706898 | Oct 2018 → Apr 2019 | HIV infectious disease | Viriom | Completed | No outcome recorded |
| Phase 1 | NCT03892161 | Apr → Nov 2018 | HIV infectious disease | University of Cape Town | Terminated | No outcome recorded |
| Phase 1 | NCT03441984 | Feb → Apr 2018 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT03199690 | Oct 2017 → Mar 2018 | HIV infectious disease, tuberculosis | St. Stephens Clinical Research | Unknown | No outcome recorded |
| Phase 1 | NCT03095638 | May → Jun 2017 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT03094507 | Apr 2017 → Jan 2018 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 1 | NCT02893488 | Sep → Nov 2016 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02738931 | May → Jun 2016 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02715479 | Apr → May 2016 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02539576 | Oct → Nov 2015 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02242799 | Jun 2015 → Sep 2016 | HIV infectious disease, malaria | University of Liverpool | Completed | No outcome recorded |
| Phase 1 | NCT02373930 | Feb → Sep 2015 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02219217 | Oct 2014 → Jan 2015 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 1 | NCT02185300 | Jul → Sep 2014 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02082808 | Mar → May 2014 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02064374 | Feb → May 2014 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01967771 | Oct 2013 → Jan 2014 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01827540 | Mar → May 2013 | HIV infectious disease | Tobira Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01762995 | Dec 2012 → Mar 2013 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01563328 | Mar → May 2012 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01467518 | Dec 2011 → Feb 2012 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01498861 | Dec 2011 → Mar 2012 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01459315 | Nov 2011 → Nov 2012 | — | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 1 | NCT01467531 | Nov 2011 → Feb 2012 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01425099 | Sep → Oct 2011 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01404806 | Aug 2011 → Aug 2012 | — | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 1 | NCT01366547 | Jun → Jul 2011 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01353716 | Jun 2011 → Apr 2012 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01382238 | Jun → Aug 2011 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01231542 | May → Nov 2011 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01332565 | Apr → Jun 2011 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01283100 | Mar 2011 | HIV infectious disease | ViiV Healthcare | Withdrawn | No outcome recorded |
| Phase 1 | NCT01231529 | Nov 2010 → Jun 2011 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01214993 | Oct → Nov 2010 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01209065 | Sep → Nov 2010 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01098513 | Apr → Jun 2010 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01098526 | Mar → May 2010 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01068925 | Feb → Apr 2010 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT00996021 | Sep → Nov 2009 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00942136 | Jul → Sep 2009 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00883935 | Apr → Jun 2009 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00867152 | Apr → May 2009 | — | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT00828763 | Feb → Mar 2009 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00858455 | Jan → Mar 2009 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00774735 | Oct → Dec 2008 | HIV infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00774111 | Oct → Dec 2008 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00726336 | Aug → Oct 2008 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00631592 | Feb → Jun 2008 | — | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT00555035 | Nov 2007 → Feb 2008 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/27 trials | ||||||
| Phase 1/2 | NCT05122767 | May 2023 → Jul 2025 overdue | HIV infectious disease, tuberculosis | The Aurum Institute NPC | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05590325 | Sep 2022 → Jun 2024 | HIV infectious disease | Desmond Tutu TB Centre | Unknown | No outcome recorded |
| Phase 1/2 | NCT03760458 | Sep 2020 → Dec 2021 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT04044001 | Nov 2019 → Mar 2022 | pulmonary tuberculosis | Michael Hoelscher | Completed | No outcome recorded |
| Phase 1/2 | NCT03435146 | Jan 2018 → Dec 2022 | HIV infectious disease, respiratory tract infectious disorder | The Aurum Institute NPC | Completed | No outcome recorded |
| Phase 1/2 | NCT02140255 | Jan 2015 → Jan 2028 expected | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT01302847 | Apr 2011 → Jan 2021 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 225 trials | ||||||
| Phase 2 | NCT06805656 | Jul 2026 → Jan 2027 expected | HIV infectious disease | Federal University of São Paulo | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06640192 | May 2025 → Dec 2026 expected | HIV infectious disease | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal | Recruiting | No outcome recorded |
| Phase 2 | NCT06338826 | Feb 2025 → Sep 2027 expected | HIV infectious disease | ANRS, Emerging Infectious Diseases | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05993767 | Dec 2024 → Jun 2025 | HIV infectious disease | PENTA Foundation | Completed | No outcome recorded |
| Phase 2 | NCT05630872 | Feb 2024 → May 2025 | tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT04734652 | Feb 2022 → Jan 2024 | HIV infectious disease, pulmonary tuberculosis | Centre for the AIDS Programme of Research in South Africa | Completed | No outcome recorded |
| Phase 2 | NCT04900038 | Aug 2021 → Nov 2022 | HIV infectious disease | ViiV Healthcare | Terminated | No outcome recorded |
| Phase 2 | NCT05006170 | Aug 2021 → Feb 2022 | congenital human immunodeficiency virus | Chulalongkorn University | Unknown | No outcome recorded |
| Phase 2 | NCT04880785 | Jul 2021 → Jun 2023 | HIV infectious disease | Fundacion SEIMC-GESIDA | Completed | No outcome recorded |
| Phase 2 | NCT04272242 | Feb → Dec 2021 | HIV infectious disease, latent tuberculosis infection | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 2 | NCT03549689 | Aug 2019 → Jul 2021 | AIDS | Philip Grant | Withdrawn | No outcome recorded |
| Phase 2 | NCT05351684 | Jan 2019 → Aug 2022 | HIV infectious disease | University of Liege | Completed | No outcome recorded |
| Phase 2 | NCT03639311 | Sep 2018 → Dec 2019 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 2 | NCT03539224 | Nov 2017 → May 2021 | HIV infectious disease | Instituto de Investigación Hospital Universitario La Paz | Unknown | No outcome recorded |
| Phase 2 | NCT03224338 | Apr 2017 → Jul 2019 | HIV infectious disease | Blueclinical, Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02551523 | Nov 2016 → Oct 2018 | — | University of Zurich | Unknown | No outcome recorded |
| Phase 2 | NCT02868580 | Oct 2016 → Dec 2017 | amyotrophic lateral sclerosis | Neuroscience Trials Australia | Completed | No outcome recorded |
| Phase 2 | NCT02572947 | Jun 2016 → Jun 2017 | HIV infectious disease | Calmy Alexandra | Completed | No outcome recorded |
| Phase 2 | NCT02582684 | Dec 2015 → Feb 2017 | HIV infectious disease | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | No outcome recorded |
| Phase 2 | NCT02527096 | Sep 2015 → Mar 2017 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | No outcome recorded |
| Phase 2 | NCT02542852 | Sep 2015 → Jun 2016 | HIV infectious disease | Castagna Antonella | Completed | No outcome recorded |
| Phase 2 | NCT02566707 | Aug 2015 → Dec 2016 | HIV infectious disease | Radboud University Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT00950859 | Aug 2009 → Nov 2010 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 2 | NCT00951015 | Jul 2009 → Feb 2010 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 2 | NCT00708110 | Jun → Aug 2008 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 2/37 trials | ||||||
| Phase 2/3 | NCT04337450 | Apr 2022 → Sep 2025 overdue | HIV infectious disease | PENTA Foundation | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT01837277 | Dec 2017 → Jul 2021 | immunodeficiency disease | Fundação Bahiana de Infectologia | Completed | No outcome recorded |
| Phase 2/3 | NCT02245022 | Mar 2017 → Dec 2018 | HIV infectious disease, pregnancy disorder | University of Liverpool | Completed | No outcome recorded |
| Phase 2/3 | NCT02259127 | Sep 2016 → Mar 2021 | HIV infectious disease | PENTA Foundation | Completed | No outcome recorded |
| Phase 2/3 | NCT02383108 | Jun 2016 → Aug 2020 | HIV infectious disease | PENTA Foundation | Completed | No outcome recorded |
| Phase 2/3 | NCT02499978 | May → Jun 2016 | AIDS | Stanford University | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT02069834 | May 2014 → Oct 2017 | HIV infectious disease | Nantes University Hospital | Withdrawn | No outcome recorded |
| Phase 354 trials | ||||||
| Phase 3 | NCT07393659 | May 2026 → Dec 2030 expected | HIV infectious disease | ViiV Healthcare | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06497465 | Sep 2025 → Jan 2028 expected | HIV infectious disease, tuberculosis | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 3 | NCT06747507 | Sep 2025 → Dec 2026 expected | HIV infectious disease | University of Nairobi | Recruiting | No outcome recorded |
| Phase 3 | NCT06658977 | Nov 2024 → Jun 2025 | amyotrophic lateral sclerosis | Macquarie University, Australia | Terminated | No outcome recorded |
| Phase 3 | NCT06444620 | Jul 2024 → Aug 2025 overdue | HIV infectious disease | University of Nairobi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06250504 | Feb 2024 → Apr 2026 overdue | HIV infectious disease | Africa Health Research Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT05979311 | Feb 2024 → Apr 2026 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05735535 | Oct 2023 → Sep 2025 | HIV infectious disease | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Unknown | No outcome recorded |
| Phase 3 | NCT05911360 | Jul 2023 → Jan 2026 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT05917509 | Jul 2023 → Sep 2025 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT04892654 | Aug 2022 → Nov 2026 expected | HIV infectious disease | Chelsea and Westminster NHS Foundation Trust | Recruiting | No outcome recorded |
| Phase 3 | NCT05193994 | Feb 2022 → Jun 2025 | amyotrophic lateral sclerosis | Macquarie University, Australia | Terminated | No outcome recorded |
| Phase 3 | NCT04808973 | Jul 2021 → Aug 2023 | HIV infectious disease, pregnancy disorder | Fundação Bahiana de Infectologia | Completed | No outcome recorded |
| Phase 3 | NCT04867083 | Jun 2021 → Jul 2023 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Unknown | No outcome recorded |
| Phase 3 | NCT04979468 | Mar 2021 → Apr 2023 | HIV infectious disease | Societa' Italiana Di Malattie Infettive E Tropicali | Unknown | No outcome recorded |
| Phase 3 | NCT04022967 | Sep 2020 → Feb 2025 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Unknown | No outcome recorded |
| Phase 3 | NCT04051970 | Nov 2019 → Jun 2022 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Terminated | No outcome recorded |
| Phase 3 | NCT04021290 | Nov 2019 → Apr 2021 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT04034862 | Oct 2019 → Mar 2023 | HIV infectious disease | University of Liege | Completed | No outcome recorded |
| Phase 3 | NCT03988452 | Jul 2019 → Sep 2020 | HIV infectious disease | Makerere University | Unknown | No outcome recorded |
| Phase 3 | NCT03945981 | Jul 2019 → Apr 2020 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT03682848 | May 2019 → Dec 2021 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT03727152 | May 2019 → Apr 2023 | HIV infectious disease | The HIV Netherlands Australia Thailand Research Collaboration | Completed | No outcome recorded |
| Phase 3 | NCT05349838 | Nov 2018 → Nov 2021 | HIV infectious disease | NEAT ID Foundation | Completed | No outcome recorded |
| Phase 3 | NCT03249181 | Jan 2018 → Oct 2020 | HIV infectious disease, pregnancy disorder | University of Liverpool | Completed | No outcome recorded |
| Phase 3 | NCT03048422 | Jan 2018 → Oct 2020 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT03446573 | Jan 2018 → May 2019 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT03016533 | Jun 2017 → Dec 2024 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT02987530 | Apr 2017 → Jul 2019 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | No outcome recorded |
| Phase 3 | NCT02976259 | Jan 2017 → Dec 2018 | HIV infectious disease | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba | Completed | No outcome recorded |
| Phase 3 | NCT02831673 | Jul 2016 → Mar 2018 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT02831764 | Jul 2016 → Apr 2018 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT02777229 | Jul 2016 → Jul 2018 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | No outcome recorded |
| Phase 3 | NCT02588820 | Apr 2016 → Nov 2018 | HIV infectious disease | David Garcia Cinca | Unknown | No outcome recorded |
| Phase 3 | NCT02596334 | Dec 2015 → Jun 2017 | HIV infectious disease | Centre Hospitalier Régional d'Orléans | Terminated | No outcome recorded |
| Phase 3 | NCT02486133 | Jul 2015 → May 2018 | HIV infectious disease | Technical University of Munich | Completed | No outcome recorded |
| Phase 3 | NCT02422797 | Apr 2015 → Sep 2016 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT02429791 | Apr 2015 → Sep 2016 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT02178592 | Jan 2015 → Nov 2017 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT02075593 | Dec 2014 → Oct 2018 | HIV infectious disease, arthropathy | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT02227238 | Dec 2014 → Aug 2017 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT02263326 | Dec 2014 → Jul 2017 | HIV infectious disease | Babafemi Taiwo | Completed | No outcome recorded |
| Phase 3 | NCT02105987 | Apr 2014 → Apr 2015 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT01966822 | Jan 2014 → Oct 2015 | HIV infectious disease | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 3 | NCT01896921 | Sep 2013 → Dec 2018 | HIV infectious disease | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 3 | NCT01910402 | Aug 2013 → Sep 2015 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT01568892 | Apr → Oct 2012 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT01499199 | Jan → Oct 2012 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT01449929 | Oct 2011 → Apr 2013 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT01328041 | May 2011 → May 2012 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT01263015 | Feb 2011 → May 2012 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT01231516 | Oct 2010 → Feb 2013 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT01227824 | Oct 2010 → Feb 2012 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT00796263 | May 2009 → Jun 2033 expected | HIV infectious disease | SEARCH Research Foundation | Recruiting | No outcome recorded |
| Phase 444 trials | ||||||
| Phase 4 | NCT06967753 | Jul 2025 → Dec 2026 expected | HIV infectious disease | UBATEC | Recruiting | No outcome recorded |
| Phase 4 | NCT07138144 | Jul 2025 → Feb 2026 overdue | HIV infectious disease | José Antonio Mata Marín | Recruiting | No outcome recorded |
| Phase 4 | NCT06787976 | Jun → Dec 2025 overdue | HIV infectious disease, anxiety, insomnia | Mexican Social Security Institute | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07031063 | Apr 2025 → Dec 2026 expected | HIV infectious disease, metabolic syndrome X | Mexican Social Security Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT06580873 | Sep 2024 → May 2026 overdue | HIV infectious disease, opiate dependence | Saskatchewan Health Authority - Regina Area | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06337032 | Aug 2024 → Mar 2034 expected | HIV infectious disease | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 4 | NCT06602622 | Aug 2024 → Nov 2025 overdue | HIV wasting syndrome | Mexican Social Security Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT06485154 | Jun 2024 → Jun 2026 overdue | — | University of Witwatersrand, South Africa | Recruiting | No outcome recorded |
| Phase 4 | NCT06037564 | Nov 2023 → Oct 2026 expected | HIV infectious disease | Insel Gruppe AG, University Hospital Bern | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT05898841 | May 2023 → Jul 2025 | HIV infectious disease, metabolic dysfunction-associated steatotic liver disease | Fundacion SEIMC-GESIDA | Completed | No outcome recorded |
| Phase 4 | NCT05493969 | Aug 2022 → Aug 2025 | AIDS | Shanghai Public Health Clinical Center | Unknown | No outcome recorded |
| Phase 4 | NCT04166474 | Nov 2021 → Feb 2024 | HIV infectious disease, tuberculosis | Helen Reynolds | Completed | No outcome recorded |
| Phase 4 | NCT04746547 | Aug 2021 → Jul 2025 | HIV infectious disease, tuberculosis | University of KwaZulu | Unknown | No outcome recorded |
| Phase 4 | NCT04636437 | Jul 2021 → Oct 2024 | HIV infectious disease | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | No outcome recorded |
| Phase 4 | NCT04884139 | Jul 2021 → Feb 2024 | HIV infectious disease | Fundacion SEIMC-GESIDA | Completed | No outcome recorded |
| Phase 4 | NCT04880395 | May 2021 → May 2024 | HIV infectious disease | Fundación Huésped | Completed | No outcome recorded |
| Phase 4 | NCT04431518 | Apr 2021 → Jul 2023 | HIV infectious disease, end stage renal failure | Indiana University | Completed | No outcome recorded |
| Phase 4 | NCT04903847 | Feb 2021 → Feb 2023 | HIV infectious disease, impaired renal function disease, lipodystrophy, obesity disorder +1 | Thomas Benfield | Unknown | No outcome recorded |
| Phase 4 | NCT04183738 | Feb 2021 → Dec 2022 | Epstein-Barr virus infection, HIV infectious disease, cytomegalovirus infection, human herpesvirus 8 infection +1 | Kirby Institute | Withdrawn | No outcome recorded |
| Phase 4 | NCT03813979 | Nov 2020 → Dec 2021 | HIV infectious disease | Radboud University Medical Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT04229290 | Feb 2020 → Sep 2021 | HIV infectious disease | University of Nairobi | Completed | No outcome recorded |
| Phase 4 | NCT03675815 | Dec 2019 → Jan 2024 | HIV infectious disease | Kirby Institute | Completed | No outcome recorded |
| Phase 4 | NCT05295394 | May 2019 → Aug 2022 | HIV infectious disease | Pedro Cahn | Withdrawn | No outcome recorded |
| Phase 4 | NCT03683524 | Nov 2018 → Aug 2021 | HIV infectious disease | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 4 | NCT04225325 | May 2018 → Sep 2019 | HIV infectious disease | ADRIANO LAZZARIN, MD | Unknown | No outcome recorded |
| Phase 4 | NCT03360682 | Apr 2018 → May 2020 | HIV infectious disease, disease related to solid organ transplantation | Fundacion Clinic per a la Recerca Biomédica | Completed | No outcome recorded |
| Phase 4 | NCT03017872 | Nov 2017 → Nov 2022 | HIV infectious disease | Kirby Institute | Unknown | No outcome recorded |
| Phase 4 | NCT03218592 | Jun 2017 → Dec 2018 | AIDS | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 4 | NCT03447873 | Jun 2017 → Sep 2020 | HIV infectious disease | Hospitales Universitarios Virgen del Rocío | Completed | No outcome recorded |
| Phase 4 | NCT03160105 | May 2017 → Apr 2018 | HIV infectious disease | Calmy Alexandra | Completed | No outcome recorded |
| Phase 4 | NCT03314064 | Dec 2016 → Oct 2018 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 4 | NCT02659761 | Nov 2016 → Sep 2021 | HIV infectious disease | University College Dublin | Terminated | No outcome recorded |
| Phase 4 | NCT02924389 | Sep 2016 → Sep 2019 | HIV infectious disease | Emory University | Terminated | No outcome recorded |
| Phase 4 | NCT02519777 | Apr 2016 → Dec 2019 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT03033836 | Dec 2015 → Jun 2019 | HIV infectious disease | Fundación Huésped | Completed | No outcome recorded |
| Phase 4 | NCT02656511 | Dec 2015 → May 2027 expected | HIV infectious disease | University of California, San Francisco | Active not recruiting | No outcome recorded |
| Phase 4 | NCT02509195 | Aug 2015 → Feb 2017 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 4 | NCT02487706 | Jun → Jul 2015 | HIV infectious disease | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 4 | NCT02513147 | Jun 2015 → Nov 2016 | — | Hospital Universitari Vall d'Hebron Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT02351908 | Mar 2015 → Apr 2016 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 4 | NCT02401828 | Mar 2015 → Jun 2017 | HIV infectious disease | Erasmus Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02285374 | Nov 2014 → Mar 2015 | HIV infectious disease | St Stephens Aids Trust | Unknown | No outcome recorded |
| Phase 4 | NCT02211482 | Oct 2014 → Mar 2016 | HIV infectious disease | Fundación Huésped | Completed | No outcome recorded |
| Phase 4 | NCT02211690 | Aug 2014 → Nov 2015 | HIV infectious disease | Andrew Carr | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT03512964 | Nov 2016 → Sep 2020 | HIV infectious disease | Johns Hopkins University | Completed | No outcome recorded |
| — | NCT02404805 | Feb → Oct 2016 | HIV infectious disease, hepatitis C virus infection | University of Colorado, Denver | Completed | No outcome recorded |
| — | NCT02384395 | Sep 2015 → Mar 2020 | HIV infectious disease | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| — | NCT02961829 | Jul 2015 → Mar 2019 | HIV infectious disease | Federal University of São Paulo | Completed | No outcome recorded |
| — | NCT01536873 | Jun 2012 → Sep 2016 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
Also used as a comparator or background therapy in 58 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03060447 Background | May 2017 → Feb 2020 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT02556268 Background | Feb → Dec 2016 | — | Bayer | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT07124559 Background | Jul 2026 → Jan 2028 expected | tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07711223 Comparator | Nov 2025 → Aug 2028 expected | HIV infectious disease | Jiangsu Aidea Pharmaceutical Group Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03577782 Background | Sep 2018 → May 2020 | HIV infectious disease | Hospitales Universitarios Virgen del Rocío | Unknown | No outcome recorded |
| Phase 1/2 | NCT03332095 Background | Jul 2018 → Aug 2020 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 214 trials | ||||||
| Phase 2 | NCT05652478 Comparator | Jul 2026 → Jan 2028 expected | cardiomyopathy hypogonadism metabolic anomalies | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 2 | NCT07555431 Comparator | May 2026 → May 2028 expected | adult T-cell leukemia/lymphoma, neuritis, tropical spastic paraparesis | Carlos Brites | Recruiting | No outcome recorded |
| Phase 2 | NCT07202546 Comparator | Feb 2026 → Jul 2027 expected | HIV infectious disease | ViiV Healthcare | Recruiting | No outcome recorded |
| Phase 2 | NCT06774872 Comparator | Apr 2025 → Jan 2027 expected | HIV infectious disease | Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | Recruiting | No outcome recorded |
| Phase 2 | NCT05729568 Background | May 2023 → Jul 2024 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04871113 Background | Jun 2021 → Oct 2022 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 2 | NCT04493216 Comparator | Nov 2020 → Sep 2022 | HIV infectious disease | ViiV Healthcare | Terminated | No outcome recorded |
| Phase 2 | NCT03851588 Comparator | Dec 2019 → Jan 2022 | HIV infectious disease, tuberculosis | University of Cape Town | Completed | No outcome recorded |
| Phase 2 | NCT03991013 Comparator | Aug 2019 → Apr 2022 | HIV infectious disease | University of Cape Town | Completed | No outcome recorded |
| Phase 2 | NCT04012931 Background | Jul 2019 → Feb 2023 | HIV infectious disease | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT03731559 Comparator | Jun 2019 → Jun 2025 overdue | tuberculosis | The HIV Netherlands Australia Thailand Research Collaboration | Recruiting | No outcome recorded |
| Phase 2 | NCT03602690 Background | Oct 2018 → Apr 2022 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Unknown | No outcome recorded |
| Phase 2 | NCT02583048 Background | Aug 2016 → Jan 2019 | HIV infectious disease, tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT02386098 Background | Jul 2015 → Jun 2017 | HIV infectious disease | ViiV Healthcare | Terminated | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT04121195 Background | Oct 2020 → May 2022 | HIV infectious disease, tuberculosis | University of Liverpool | Completed | No outcome recorded |
| Phase 2/3 | NCT02285114 Background | Jan 2015 → Nov 2019 | — | Gilead Sciences | Completed | No outcome recorded |
| Phase 318 trials | ||||||
| Phase 3 | NCT07683000 Background | Jul 2026 → Mar 2029 expected | HIV infectious disease | Gilead Sciences | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06203132 Comparator | Jan 2025 → Nov 2026 expected | HIV infectious disease | ANRS, Emerging Infectious Diseases | Recruiting | No outcome recorded |
| Phase 3 | NCT06630299 Comparator | Oct 2024 → Apr 2026 overdue | HIV infectious disease | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05154747 Comparator | Jun 2023 → Mar 2025 | HIV infectious disease | University College, London | Unknown | No outcome recorded |
| Phase 3 | NCT05546242 Comparator | Dec 2022 → Apr 2025 overdue | HIV infectious disease | MRC/UVRI and LSHTM Uganda Research Unit | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04155554 Comparator | Jan → Aug 2020 | HIV infectious disease | University Hospital of Siena | Unknown | No outcome recorded |
| Phase 3 | NCT03631732 Comparator | Aug 2018 → Aug 2019 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT03547908 Comparator | May 2018 → Feb 2022 | — | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT03256422 Background | Sep 2017 → Aug 2019 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | No outcome recorded |
| Phase 3 | NCT03493568 Comparator | Feb 2017 → Mar 2018 | HIV infectious disease | IRCCS San Raffaele | Terminated | No outcome recorded |
| Phase 3 | NCT03122262 Comparator | Jan 2017 → Apr 2022 | HIV infectious disease | Professor Francois Venter | Completed | No outcome recorded |
| Phase 3 | NCT02938520 Comparator | Oct 2016 → Aug 2018 overdue | HIV infectious disease | ViiV Healthcare | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02616783 Comparator | Dec 2015 → Feb 2018 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02605954 Comparator | Nov 2015 → Jun 2017 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02607956 Comparator | Nov 2015 → May 2017 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02469246 Background | Jun 2015 → Dec 2017 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT02302547 Comparator | Dec 2014 → Aug 2017 | HIV infectious disease | University Hospital, Tours | Completed | No outcome recorded |
| Phase 3 | NCT02121795 Background | May 2014 → Aug 2015 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 415 trials | ||||||
| Phase 4 | NCT07673965 Comparator | Aug 2026 → Aug 2027 expected | HIV infectious disease | University of Witwatersrand, South Africa | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07616739 Comparator | Jun 2026 → Jul 2028 expected | HIV infectious disease | Fundación Huésped | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05630638 Comparator | Oct 2023 → Jul 2028 expected | HIV infectious disease | University of Liverpool | Recruiting | No outcome recorded |
| Phase 4 | NCT05549180 Comparator | Oct 2022 → Feb 2024 | HIV infectious disease | Fundacion SEIMC-GESIDA | Completed | No outcome recorded |
| Phase 4 | NCT04910711 Comparator | Oct 2021 → Aug 2023 | HIV infectious disease | Botswana Harvard AIDS Institute Partnership | Unknown | No outcome recorded |
| Phase 4 | NCT04549467 Background | Nov 2020 → Sep 2023 | HIV infectious disease | Fundacion IDEAA | Completed | No outcome recorded |
| Phase 4 | NCT04904406 Background | Oct 2020 → Dec 2023 | HIV infectious disease, cardiovascular disorder, lipodystrophy | Thomas Benfield | Completed | No outcome recorded |
| Phase 4 | NCT04340388 Comparator | Sep 2020 → Jun 2022 | HIV infectious disease, congenital anomaly of cardiovascular system, lipodystrophy, obesity disorder +2 | Augusta University | Completed | No outcome recorded |
| Phase 4 | NCT04442737 Comparator | Jul 2020 → Aug 2023 | — | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 4 | NCT04553081 Comparator | May 2020 → Jun 2026 overdue | HIV infectious disease | University Hospital, Ghent | Recruiting | No outcome recorded |
| Phase 4 | NCT04295460 Background | Mar 2020 → Jan 2022 | HIV infectious disease | Hospitales Universitarios Virgen del Rocío | Unknown | No outcome recorded |
| Phase 4 | NCT04054089 Comparator | Jan 2020 | HIV infectious disease | Cristina Mussini | Completed | No outcome recorded |
| Phase 4 | NCT02500446 Comparator | Sep 2015 → Sep 2016 | HIV infectious disease | University of Melbourne | Completed | No outcome recorded |
| Phase 4 | NCT02337322 Comparator | Mar 2015 → Dec 2019 | HIV infectious disease | Juan A. Arnaiz | Unknown | No outcome recorded |
| Phase 4 | NCT02098837 Comparator | Apr 2014 → Nov 2017 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07618507 Comparator | Apr 2022 → Mar 2024 | HIV infectious disease | Federal University of São Paulo | Completed | No outcome recorded |
| — | NCT05044962 Comparator | Nov 2021 → Mar 2027 expected | HIV infectious disease | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02028819 Background | Jan 2012 → Feb 2014 | HIV infectious disease | University of Colorado, Denver | No longer available | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-09-05 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC), a Once-daily Treatment for Children Living with HIV viatris.com ↗ |
| 2020-11-23 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Viatris Inc. Announces FDA Tentative Approval of a Pediatric Formulation of Dolutegravir (DTG) Under PEPFAR viatris.com ↗ |
| 2018-03-05 | Gilead Sciences | Gilead Presents Results from Phase 3 Study Evaluating Patients Who Switched to Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) from Regimen Containing Abacavir, Dolutegravir and Lamivudine gilead.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 278 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dolutegravir | “The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus...” NCT03547908 ↗234“This study is conducted to demonstrate non-inferior antiviral activity at 48 weeks of a dolutegravir (DTG) containing regimen compared to a WHO-recommended standard of care...” NCT02227238 ↗ “ART that concurrently contains combinations of non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as...” NCT05044962 ↗ “Antiretroviral therapy, administered orally may include regimens such as: bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir...” NCT05729568 ↗ “Second generation integrase inhibitor 1) Bictegravir 50 mg/ alafenamide tenofovir 25 mg/ emtricitabine 200 mg (BIC/TAF/FTC); 2) Dolutegravir 50 mg/ abacavir 600 mg/ lamivudine...” NCT06602622 ↗ “We randomly assigned (1:1) participants to receive dolutegravir 50 mg plus lamivudine 300 mg or a three-drug regimen including dolutegravir 50 mg plus tenofovir disoproxil...” PMID 39826566 ↗ Jan 2025 “The three antiretroviral drugs have been chosen because they are the only ones that allow administration at higher doses without causing increased toxicity: dolutegravir 50...” NCT06640192 ↗ “The pharmacokinetics (PK) of dolutegravir (DTG) and rilpivirine (RPV), the components of JULUCA, in patients with end stage renal disease (ESRD) requiring hemodialysis (HD)...” NCT04431518 ↗ “Bictegravir 50 mg / tenofovir alafenamide 25 mg / emtricitabine 200 mg or dolutegravir 50 mg / lamivudine 300 mg / abacavir 600 mg, both combinations in a single tablet, will...” NCT07138144 ↗ “Relative Bioavailability Study to Investigate a Potential Interaction Between Dolutegravir (DTG) and Tenofovir Alafenamide Fumarate/Emtricitabine (F/TAF) Administered as...” NCT05489406 ↗ “The abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) 600 milligrams (mg)/50 mg/300 mg fixed-dose combination (FDC) tablet is currently approved in the United States (US) and Europe.” NCT02539576 ↗ “The integrase (INI) inhibitors (for example, bictegravir, dolutegravir, elvitegravir/cobicistat, and raltegravir) will be administered in combination with TAF/FTC, as appropriate.” NCT04442737 ↗ “the dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) fixed dose combination (FDC) tablet is being made available to women who become pregnant while participating in study ING117172” NCT02075593 ↗ “Antiretroviral treatment consisting in Dolutegravir (Tivicay) (50mg) + Tenofovir alafenamide (TAF) (25mg) / Emtricitabina (FTC) (200mg) (Descovy), once daily during 24 weeks.” NCT03577782 ↗ “Doravirine 100 mg (Pifeltro®) will be administered once daily in combination with co-formulated dolutegravir/lamivudine 50/300 mg (Dovato®) for a duration of 48 weeks.” NCT06037564 ↗ “The following agents are allowed as part of the ART regimen: nucleoside reverse transcriptase inhibitors, raltegravir, dolutegravir (DTG), rilpivirine, and maraviroc.” NCT03060447 ↗ “Ritonavir-boosted darunavir (DRV/r) and dolutegravir (DTG) are affected by induction of metabolizing enzymes and efflux transporters caused by rifampicin (RIF).” PMID 35583344 ↗ May 2022 “film-coated tablet contains abacavir sulphate equivalent to 600 mg of abacavir, dolutegravir sodium equivalent to 50 mg dolutegravir, and 300 mg of lamivudine.” NCT02938520 ↗ “SBRs include medicines like bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) or dolutegravir (DTG)+ tenofovir alafenamide (TAF)+ emtricitabine (FTC).” NCT07683000 ↗ “An Open-Label, Single Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of GSK1349572 (Dolutegravir, DTG) in Healthy Japanese Subjects” NCT01332565 ↗ “Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs).” NCT03332095 ↗ “Dolutegravir SE study compared conventional dolutegravir 50 and 25 mg with equivalent conventional 10-mg and dispersible 5-mg tablets, respectively.” PMID 34817414 ↗ Mar 2022 “Dolutegravir 50 mg BID throughout the study period ensured participants remained protected from subtherapeutic atazanavir concentrations.” PMID 37982585 ↗ May 2024 “Participants elected to switch to either CAB+RPV long-acting Q2M or daily oral dolutegravir/RPV for maintenance of virologic suppression.” PMID 34652287 ↗ Feb 2022 “Triumeq, a combination of dolutegravir, abacavir and lamivudine is an anti-retroviral therapy indicated for people with HIV-1 infection.” NCT02868580 ↗ “Tenofovir+Emtricitabine+Third agent (Including an integrase inhibitor raltegravir or dolutegravir or cobicistat-boosted elvitegravir” NCT02302547 ↗ “Dolutegravir will be supplied as a white, film-coated, round tablet with a unit dose strength of 50 mg to be administered orally” NCT02373930 ↗ “Immediate Bitherapy (BI) strategy Dolutegravir (DTG, Tivicay® 50 mg QD) plus lamivudine (3TC, 300 mg QD) between D0 and W96.” NCT04051970 ↗ “Dolutegravir (DTG) is a potent INSTI that exhibits rapid and potent viral load reduction and a high barrier to resistance.” NCT05735535 ↗ “Of 93 participants randomised to dolutegravir plus emtricitabine and 94 individuals to combination antiretroviral therapy” PMID 38754068 ↗ Apr 2024 “Generic TAF/E/D (tenofovir alafenamide 25mg/emtricitabine 200mg/dolutegravir 50 mg), a single-tablet once daily regimen” NCT03727152 ↗ “Dual therapy of 2 drugs co-formulated in 1 tablet: Dolutegravir 50 mg/ lamivudine 300 mg, it is the experimental group” NCT07031063 ↗ “Dolutegravir 50 mg once daily with food plus 2NRTIs in HIV/TB co-infected patients receiving RIF based anti-TB therapy” NCT03731559 ↗ “Dolutegravir 50mg oral with tenofovir disoproxil fumarate (245mg) and lamivudine (300mg) in a fixed dose combination” NCT05154747 ↗ “Once-daily dolutegravir 50 mg with tenofovir disoproxil fumarate 300 mg and lamivudine 300 mg was initiated on day 0” PMID 40349709 ↗ May 2025 “Each DTG tablet contained 52.62 mg dolutegravir sodium salt, which was equivalent to 50 mg dolutegravir free acid.” NCT02422797 ↗ “Each DTG tablet contained 52.62 mg dolutegravir sodium salt, which was equivalent to 50 mg dolutegravir free acid.” NCT02429791 ↗ “efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP)” NCT02469246 ↗ “Allowed unboosted 3rd ARV agents: efavirenz (EFV), raltegravir (RAL), dolutegravir (DTG), or nevirapine (NVP)” NCT02285114 ↗ “Pharmacokinetics, Safety, and Efficacy of Dolutegravir Dispersible Tablets in Young Children Living With HIV” NCT05006170 ↗ “This is a fixed-dose combined DTG/3TC pill each containing 50mg of dolutegravir and 300mg of lamivudine” NCT06444620 ↗ “received single once-daily dolutegravir-lamivudine fixed-dose combination tablet orally for 48 weeks” PMID 39988749 ↗ Jun 2025 “Patients will receive the Tenofovir/Lamiduvine NRTI drugs along with the Dolutegravir for 24 weeks.” NCT07618507 ↗ “remain suppressed upon switching to dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC).” NCT04021290 ↗ “Healthy participants received dolutegravir 50 mg once daily (QD) on Days 1-5 in period 1” PMID 33533507 ↗ Mar 2021 “Oral antiretroviral therapy in the form of 2NRTIs + dolutegravir 50mg administered daily” NCT05546242 ↗ “600 mg abacavir, 50 mg dolutegravir, and 300 mg lamivudine, i.e. 1 tablet, once daily” NCT02556268 ↗ “Dolutegravir (DTG) is primarily metabolized by UGT1A1 with CYP3A as a minor route.” PMID 26898568 ↗ Feb 2016 “two-drug regimen of dolutegravir (DTG) 50 milligram (mg) + lamivudine (3TC) 300 mg” NCT03446573 ↗ “Dolutegravir 50 mg QD plus co-formulated emtricitabine 200 mg/tenofovir 300 mg QD.” NCT03033836 ↗ “Switch to dual therapy with Dolutegravir (50 mg) + lamivudine (300 mg) once daily” NCT03447873 ↗ “52.62 mg Dolutegravir sodium which is equivalent to 50 mg Dolutegravir free acid” NCT02105987 ↗ “integrase inhibitors : dolutegravir, elvitegravir/cobicistat ou raltegravir” NCT03256422 ↗ “158 INSTI + DRV/r [153 Dolutegravir (DTG); 5 Elvitegravir (EVG)], 160 SOC.” PMID 37304494 ↗ Jun 2023 “Dolutegravir 50 mg/j + Rilpivirine 25 mg/j qd orally (intake during meal)” NCT02069834 ↗ “Dolutegravir (DTG) is an HIV drug in the integrase inhibitor drug class.” NCT01302847 ↗ “INSTI = bictegravir, dolutegravir, elvitegravir/cobicistat, raltegravir” NCT06338826 ↗ “including bictegravir (BIC), dolutegravir (DTG), or raltegravir (RAL)” NCT04636437 ↗ “early switching to dolutegravir/lamivudine (DTG/3TC) in single-pill” NCT04979468 ↗ “Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen” NCT05917509 ↗ “dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC)” NCT05911360 ↗ “Name of active ingredients:Abacavir/lamivudine/dolutegravir” NCT02509195 ↗ “HIV integrase strand transfer inhibitor dolutegravir (DTG)” PMID 27450277 ↗ Jul 2016 “Dolutegravir 50mg /Lamivudine 300mg/ Tenofovir 300mg” NCT04734652 ↗ “switch to dolutegravir/lamivudine (DTG/3TC, n = 89)” PMID 39226296 ↗ Feb 2025 “dolutegravir (DTG)/abacavir (ABC)/lamivudine (3TC)” NCT06630299 ↗ “Dolutegravir+Emtricitabine/Tenofovir Alafenamide” NCT07711223 ↗ “1. Dolutégravir 50mg / Lamivudine 300mg per day” NCT04867083 ↗ “TRIUMEQ (Dolutegravir/Abacavir/Lamivudine)” NCT04827134 ↗ “dolutegravir(DTG) 50 mg orally once daily” NCT00796263 ↗ “dolutegravir [DTG]/abacavir/lamivudine” PMID 37200995 ↗ May 2023 “3. Dolutegravir 50 mg once a day” NCT02588820 ↗ “unboosted dolutegravir (DTG)” NCT06337032 ↗ “dolutegravir (DTG; Tivicay®)” NCT02605954 ↗ “dolutegravir (DTG;Tivicay®)” NCT02121795 ↗ “dolutegravir (DTG;Tivicay®)” NCT02616783 ↗ “GSK1349572 (dolutegravir)” NCT01227824 ↗ “GSK1349572 (dolutegravir)” NCT01404806 ↗ “dolutegravir/lamivudine” NCT04295460 ↗ “dolutegravir \[DTG\]” NCT04012931 ↗ “Dolutegravir (DTG)” NCT02178592 ↗ “dolutegravir (DTG)” NCT03631732 ↗ |
| Known as | 14C-GSK1349572 | “An Open Label, Non-Randomized, Single Dose, Mass Balance Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK1349572 20 mg, Administered as a Single...” NCT00828763 ↗ |
| Known as | Dolutegravir free acid | “52.62 mg Dolutegravir sodium which is equivalent to 50 mg Dolutegravir free acid” NCT02105987 ↗ |
| Known as | Dolutegravir sodium | “52.62 mg Dolutegravir sodium which is equivalent to 50 mg Dolutegravir free acid” NCT02105987 ↗1“Azvudine tablets(FNC) and Dolutegravir Sodium Tablets (DTG)” NCT07002229 ↗ |
| Known as | DOVATO | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06580873 ↗ |
| Known as | DTG | “The aim of this study is to assess the efficacy and tolerability of a dual combined therapy of Dolutegravir (DTG) 50 mg Once Daily (OD) + Rilpivirine (RPV) 25 mg OD in...” NCT05349838 ↗100“Dolutegravir (DTG), a human immunodeficiency virus (HIV)-1 integrase inhibitor (INI), and Rilpivirine (RPV), a non-nucleoside HIV-1 reverse transcriptase inhibitor (NNRTI), are...” NCT03984838 ↗ “In the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) 2010/VESTED study, pregnant women were randomized to initiate dolutegravir (DTG) +...” PMID 38877762 ↗ Nov 2024 “A Single-arm Study of the Safety, Efficacy and Central Nervous System and Plasma PK of GSK1349572 (Dolutegravir, DTG) 50 mg Once Daily in Combination With the...” NCT01499199 ↗ “This study will be a phase 1, open label, parallel group, three period crossover study to evaluate the effect of dolutegravir (DTG) on the steady state pharmacokinetics of...” NCT02064374 ↗ “Investigational Product Tenofovir disoproxil fumarate / lamivudine / dolutegravir Dosage Formulation 300 mg / 300 mg / 50 mg fixed dose combination tablet Route of...” NCT06485154 ↗ “Calcium and Iron supplementations are commonly used and both of these have the potential to interact with Dolutegravir (DTG), this study will evaluate the potential of calcium...” NCT01762995 ↗ “The aim of this trial was to compare the immune reconstitution, virologic response, and safety of dolutegravir (DTG) vs. darunavir (DRV) boosted-based antiretroviral (ART)...” PMID 41083105 ↗ Oct 2025 “Participants received one oral tablet of 50 mg DTG daily administered concomitantly with RPV. Each DTG tablet contained 52.62 mg dolutegravir sodium salt, which was equivalent...” NCT02422797 ↗ “Relative Bioavailability Study to Investigate a Potential Interaction Between Dolutegravir (DTG) and Tenofovir Alafenamide Fumarate/Emtricitabine (F/TAF) Administered as...” NCT05489406 ↗ “The study aims to evaluate the virological effectiveness of a third-line regimen combining dolutegravir (DTG), ritonavir-boosted darunavir (DRV/r) and optimized NRTI in...” NCT03602690 ↗ “Here, we intensified the ART regimen by doubling dolutegravir (DTG) dosage and investigated the impact of this strategy on HIV blood and tissue reservoirs, immune activation,...” PMID 41575190 ↗ Jan 2026 “This is an open-label, single-center, single dose, non-randomized, sequential, fixed-sequence study, which will evaluate pharmacokinetics (PK) of dolutegravir (DTG) in healthy...” NCT03921723 ↗ “bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) or dolutegravir/lamivudine/abacavir (DTG/3TC/ABC), are associated with metabolic, renal, and cardiovascular adverse effects” NCT07138144 ↗ “The abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) 600 milligrams (mg)/50 mg/300 mg fixed-dose combination (FDC) tablet is currently approved in the United States (US) and Europe.” NCT02539576 ↗ “Treatment including dolutegravir (DTG 50mg) + tenofovir/emtricitabine (TDF/FTC 245 mg/200 mg) initiated by the referee physician within a maximum of 15 days after diagnosis of PHI” NCT02976259 ↗ “the dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) fixed dose combination (FDC) tablet is being made available to women who become pregnant while participating in study ING117172” NCT02075593 ↗ “Dolutegravir (DTG) and lamivudine (3TC) are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.” NCT02738931 ↗ “using standard adult doses of artemether-lumefantrine or artesunate-amodiaquine given with 50 mg once daily dolutegravir (DTG) to investigate the drug-drug interaction between” PMID 30420479 ↗ Jan 2019 “Increasing evidence suggests that dolutegravir (DTG), endorsed by the WHO since 2018 for first-line antiretroviral therapy (ART), is associated with significant weight gain” PMID 41644158 ↗ Feb 2026 “The DYNAMIC study evaluated the efficacy and safety of the maturation inhibitor GSK3640254 (GSK'254) plus dolutegravir (DTG) in adults naive to antiretroviral therapy.” PMID 41357331 ↗ Oct 2025 “Dolutegravir (DTG, GSK1349572) is an integrase inhibitor currently in Phase 3 clinical trials for the treatment of human immunodeficiency virus (HIV) infection.” NCT01382238 ↗ “Ritonavir-boosted darunavir (DRV/r) and dolutegravir (DTG) are affected by induction of metabolizing enzymes and efflux transporters caused by rifampicin (RIF).” PMID 35583344 ↗ May 2022 “SBRs include medicines like bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) or dolutegravir (DTG)+ tenofovir alafenamide (TAF)+ emtricitabine (FTC).” NCT07683000 ↗ “An Open-Label, Single Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of GSK1349572 (Dolutegravir, DTG) in Healthy Japanese Subjects” NCT01332565 ↗ “Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs).” NCT03332095 ↗ “The integrase inhibitor under investigation in this study, Dolutegravir (DTG), is relatively new to the market only having been approved in 2014.” NCT03199690 ↗ “Randomised, controlled, superiority trial of virologically suppressed PLWH on dolutegravir, abacavir and lamivudine (DTG/ABC/3TC) for ≥6 months.” PMID 37604629 ↗ Aug 2023 “a fixed-dose combination oral tablet of dolutegravir/lamivudine (DTG/3TC) and cabotegravir plus rilpivirine long-acting agents (CAB + RPV LA).” NCT05917509 ↗ “Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3 clinical development for the treatment of HIV infection.” NCT01467518 ↗ “Dolutegravir group (DTG+2 NRTIs) - to make best comparison with standard of care, these NRTIs should be those recommended by national policy.” NCT03249181 ↗ “Immediate Bitherapy (BI) strategy Dolutegravir (DTG, Tivicay® 50 mg QD) plus lamivudine (3TC, 300 mg QD) between D0 and W96.” NCT04051970 ↗ “Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily.” NCT03682848 ↗ “Dolutegravir (DTG) is a potent INSTI that exhibits rapid and potent viral load reduction and a high barrier to resistance.” NCT05735535 ↗ “Each DTG tablet contained 52.62 mg dolutegravir sodium salt, which was equivalent to 50 mg dolutegravir free acid.” NCT02429791 ↗ “efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP)” NCT02469246 ↗ “Allowed unboosted 3rd ARV agents: efavirenz (EFV), raltegravir (RAL), dolutegravir (DTG), or nevirapine (NVP)” NCT02285114 ↗ “Dolutegravir (DTG) is an HIV-1 integrase inhibitor approved in the United States, Canada, Australia and EU.” NCT02185300 ↗ “This is a fixed-dose combined DTG/3TC pill each containing 50mg of dolutegravir and 300mg of lamivudine” NCT06444620 ↗ “Subjects will switch to dolutegravir (DTG) plus lamivudine (3TC) or fixed dose combination DTG/3TC.” NCT05493969 ↗ “remain suppressed upon switching to dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC).” NCT04021290 ↗ “fixed dose combination (FDC) of Dolutegravir (DTG) plus Lamivudine (3TC) as a first line regimen” NCT03945981 ↗ “two-drug regimen of dolutegravir (DTG) 50 milligram (mg) + lamivudine (3TC) 300 mg” NCT03446573 ↗ “50mg dolutegravir (DTG) one tablet orally once daily for 4 wks (Day 14 to Day 42)” NCT05652478 ↗ “dolutegravir (DTG) monotherapy could be used to maintain virological suppression” PMID 30601976 ↗ Oct 2019 “twice-daily dolutegravir exposures together with HP vs. when DTG is given alone” NCT05122767 ↗ “Dolutegravir (DTG) 50MG/lamivudine (3TC) 300MG FIXED DOSE COMBINATION (FDC)” NCT03549689 ↗ “dolutegravir (DTG)/emtricitabine (FTC)/tenofovir alafenamide (TAF) regimen” NCT05993767 ↗ “158 INSTI + DRV/r [153 Dolutegravir (DTG); 5 Elvitegravir (EVG)], 160 SOC.” PMID 37304494 ↗ Jun 2023 “Dolutegravir (DTG) is an HIV drug in the integrase inhibitor drug class.” NCT01302847 ↗ “dolutegravir, DTG (50 mg once daily \[QD\]) administered in combination” NCT03122262 ↗ “Dolutegravir (DTG) plus lamivudine (3TC) is a dual regimen combination” NCT04880785 ↗ “Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets” NCT03760458 ↗ “including bictegravir (BIC), dolutegravir (DTG), or raltegravir (RAL)” NCT04636437 ↗ “Dolutegravir 50 mg/ abacavir 600 mg/ lamivudine 300 mg (DTG/ABC/3TC)” NCT06602622 ↗ “steady-state dolutegravir (DTG) and rifapentine (RPT) concentrations” NCT06281834 ↗ “Dolutegravir (DTG) is an integrase strand transfer inhibitor (INSTI)” NCT02659761 ↗ “Participants will receive a single oral dose of dolutegravir (DTG).” NCT07532304 ↗ “early switching to dolutegravir/lamivudine (DTG/3TC) in single-pill” NCT04979468 ↗ “Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TC” NCT05630872 ↗ “dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC)” NCT05911360 ↗ “Dolutegravir (DTG) 50 mg/day + Rilpivirine (RPV) 25mg per day” NCT05898841 ↗ “Azvudine tablets(FNC) and Dolutegravir Sodium Tablets (DTG)” NCT07002229 ↗ “HIV integrase strand transfer inhibitor dolutegravir (DTG)” PMID 27450277 ↗ Jul 2016 “Dolutegravir (DTG) plus Darunavir/cobicistat (DRV/cobi).” NCT03683524 ↗ “dolutegravir (DTG)-associated drug-resistant mutations” NCT06747507 ↗ “Dolutegravir (DTG), a HIV-1 integrase inhibitor (INI)” NCT02373930 ↗ “switch to dolutegravir/lamivudine (DTG/3TC, n = 89)” PMID 39226296 ↗ Feb 2025 “dolutegravir (DTG, GSK1349572) containing regimen” NCT01568892 ↗ “GSK1349572 (Dolutegravir, DTG) 50 mg Once Daily” NCT01449929 ↗ “Dolutegravir (DTG)/lamivudine dual therapy (DT)” PMID 40874763 ↗ Feb 2026 “Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC)” NCT01910402 ↗ “Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF” NCT04493216 ↗ “dolutegravir(DTG) 50 mg orally once daily” NCT00796263 ↗ “Dolutegravir (DTG) and lamivudine (3TC)” NCT04337450 ↗ “dolutegravir (DTG) containing regimen” NCT01328041 ↗ “Dolutegravir (DTG)/ Lamivudine (3TC)” NCT07393659 ↗ “Dolutegravir / Lamivudine (DTG/3TC)” NCT07202546 ↗ “Dolutegravir + Lamivudine (DTG/3TC)” NCT04022967 ↗ “dolutegravir (DTG; Tivicay®)” NCT02605954 ↗ “unboosted dolutegravir (DTG)” NCT06337032 ↗ “dolutegravir (DTG;Tivicay®)” NCT02616783 ↗ “dolutegravir \[DTG\]” NCT04012931 ↗ “Drug: TIVICAY (DTG)” NCT02893488 ↗ “dolutegravir (DTG)” NCT03631732 ↗ “Dolutegravir (DTG)” NCT03224338 ↗ “Dolutegravir (DTG)” NCT02831673 ↗ “Dolutegravir (DTG)” NCT03016533 ↗ “Dolutegravir (DTG)” NCT04272242 ↗ “Dolutegravir (DTG)” NCT06787976 ↗ “Dolutegravir (DTG)” NCT03539224 ↗ “Dolutegravir (DTG)” NCT02386098 ↗ “Dolutegravir (DTG)” NCT02519777 ↗ “Dolutegravir (DTG)” NCT02178592 ↗ “Dolutegravir (DTG)” NCT02140255 ↗ |
| Known as | GSK1349572 | “A Single-arm Study of the Safety, Efficacy and Central Nervous System and Plasma PK of GSK1349572 (Dolutegravir, DTG) 50 mg Once Daily in Combination With the...” NCT01499199 ↗35“Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3 clinical development for the treatment of human immunodeficiency virus (HIV) infection.” NCT01563328 ↗ “Dolutegravir (DTG, GSK1349572) is an integrase inhibitor currently in Phase 3 clinical trials for the treatment of human immunodeficiency virus (HIV) infection.” NCT01382238 ↗ “Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3 clinical development for the treatment of HIV infection.” NCT01467518 ↗ “Dolutegravir (GSK1349572), a once-daily HIV integrase inhibitor, has shown potent antiviral response and a favourable safety profile.” PMID 23830355 ↗ Jul 2013 “Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine” NCT05030025 ↗ “Subjects will take a GSK1349572 (dolutegravir) 50mg tablet by mouth once daily for 8 days.” NCT01459315 ↗ “Dolutegravir (also known as GSK1349572) 50 mg taken once daily” NCT01263015 ↗ “Dolutegravir (DTG, GSK1349572 is an integrase inhibitor” NCT01498861 ↗ “GSK1349572 (Dolutegravir, DTG) 50 mg Once Daily” NCT01449929 ↗ |
| Known as | Tivicay | “All participants will be administered Tivicay® (dolutegravir 50 mg once daily) for 10 days, then will undergo a nine-day wash out period and then take Stribild® (245 mg of...” NCT02219217 ↗11“They may be administered in combination as 50/25 mg/day tablets (Juluca 50/25) or separately as Dolutegravir 50 mg/d tablets together with Rilpivirine 25 mg/d tablets (Tivicay...” NCT05898841 ↗ “Tenofovir Disoproxil Fumarate TDF/Viread, Tenovovir Alafenamide TAF/Vemlidy, Dolutegravir DTG/Tivicay, or both TAF and DTG taken together for 4 weeks.” NCT05652478 ↗ “Immediate Bitherapy (BI) strategy Dolutegravir (DTG, Tivicay® 50 mg QD) plus lamivudine (3TC, 300 mg QD) between D0 and W96.” NCT04051970 ↗ “Tivicay® (Dolutegravir 50 mg) 1 tablet once a day + Truvada® (FTC & Tenofovir)” NCT02351908 ↗ “switch of the third agent with dolutegravir(Tivicay®) 50 mg once a day.” NCT02527096 ↗ “dolutegravir (DTG; Tivicay®)” NCT02605954 ↗ “dolutegravir (DTG;Tivicay®)” NCT02616783 ↗ “Dolutegravir (Tivicay)” NCT03577782 ↗ |
| Action | Inhibit | “It is in the class of integrase inhibitors.” NCT00708110 ↗ |
| Modality | Other / unclassified | “Integrase inhibitors (INI), such as dolutegravir (DTG)” NCT02178592 ↗ |
| Route | Oral | “dolutegravir(DTG) 50 mg orally once daily” NCT00796263 ↗ |