Drugs / Dolutegravir
Dolutegravir
also known as
DTG · GSK1349572 · Tivicay · Dolutegravir Sodium · DOVATO · 14C-GSK1349572 · Dolutegravir free acid
Regulatory milestones approvals, filings & regulatory actions · 21 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed HIV infectious disease 12 milestones | |||||
| Filed | US (FDA) | Tivicay PD | HIV infectious disease | 2026-06-22 | “FDA has accepted the supplemental New Drug Application (sNDA) to extend the use of Tivicay PD (dolutegravir (DTG)) to newborns from birth.” viivhealthcare.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2020-11-13 | “Mylan and Macleods have both submitted a new drug application for a scored dolutegravir 10mg dispersible tablet for tentative approval under the FDA” viivhealthcare.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2019-12-13 | “ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir (DTG) for children living with HIV” viivhealthcare.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2019-12-13 | “ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir (DTG) for children living with HIV” viivhealthcare.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2018-10-18 | “New two-drug regimen dolutegravir (DTG) and lamivudine (3TC) for HIV filed in US and Europe” gsk.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2018-09-14 | “New two-drug regimen dolutegravir (DTG) and lamivudine (3TC) for HIV filed in US and Europe” gsk.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2017-06-01 | “today announced regulatory submissions to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for a single-tablet, two-drug regimen of dolutegravir” gsk.com ↗ “regulatory submissions were made to both the European Medicines Agency and the FDA for a single-tablet, two-drug regimen of dolutegravir and rilpivirine” jnj.com ↗ “HIV two drug regimen (dolutegravir and rilpivirine) filed for approval in US and EU” gsk.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2017-06-01 | “today announced regulatory submissions to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for a single-tablet, two-drug regimen of dolutegravir” gsk.com ↗ “regulatory submissions were made to both the European Medicines Agency and the FDA for a single-tablet, two-drug regimen of dolutegravir and rilpivirine” jnj.com ↗ “HIV two drug regimen (dolutegravir and rilpivirine) filed for approval in US and EU” gsk.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2013-10-25 | “ViiV Healthcare today announced the submission of a regulatory application in Europe for its investigational single-tablet regimen (STR) combining dolutegravir (DTG), abacavir...” gsk.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2013-10-22 | “ViiV Healthcare today announced the submission of a regulatory application in the United States for its investigational single-tablet regimen (STR) combining dolutegravir,...” gsk.com ↗ |
| Filed | EU (EMA) | Triumeq | HIV infectious disease | 2012-12-17 | “an application to approve the new dispersible tablet of the fixed dose combination of abacavir, dolutegravir and lamivudine for the treatment of paediatric patients with human...” viivhealthcare.com ↗ “ViiV Healthcare submitted a Marketing Authorisation Application (MAA) for dolutegravir to the European Medicines Agency (EMA) on 17 December, 2012.” gsk.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2012-12-17 | “ViiV Healthcare and CHAI collaboration delivers second milestone with first filing with the FDA of generic dolutegravir by Aurobindo Pharma for the treatment of HIV.” viivhealthcare.com ↗ “Mylan submitted a new drug application for a scored dolutegravir 10mg dispersible tablet for tentative approval under the FDA” viivhealthcare.com ↗ “The new drug application (NDA) for dolutegravir was received by the FDA on 17 December 2012” gsk.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| 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
today
US approved 2013
EU approved 2014
1
5
9
8
16
5
4
13
22
19
14
12
17
5
18
10
6
11
8
3
200820092010201120122013201420152016201720182019202020212022202320242025202620272028
| 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 | NCT01498861 | Dec 2011 → Mar 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 | NCT01467531 | Nov 2011 → Feb 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 | 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 | NCT01353716 | Jun 2011 → Apr 2012 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01366547 | Jun → Jul 2011 | 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 | NCT00774111 | Oct → Dec 2008 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00774735 | Oct → Dec 2008 | HIV infectious disease | 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 · 2 met primary | ||||||
| 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 Stop: Business |
| 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 | Met primary |
| 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 Stop: Enrollment |
| 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 | Met primary |
| Phase 2/37 trials · 2 met primary | ||||||
| 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 | Met primary |
| Phase 2/3 | NCT02383108 | Jun 2016 → Aug 2020 | HIV infectious disease | PENTA Foundation | Completed | Met primary |
| 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 Stop: Business |
| Phase 354 trials · 18 met primary · 2 missed | ||||||
| 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 | Met primary |
| 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 | Missed primary |
| 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 Stop: Enrollment |
| Phase 3 | NCT04021290 | Nov 2019 → Apr 2021 | HIV infectious disease | ViiV Healthcare | Completed | Met primary |
| 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 | Met primary |
| 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 | Mixed |
| Phase 3 | NCT03446573 | Jan 2018 → May 2019 | HIV infectious disease | ViiV Healthcare | Completed | Met primary |
| 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 | Missed primary |
| 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 | Met primary |
| Phase 3 | NCT02831764 | Jul 2016 → Apr 2018 | HIV infectious disease | ViiV Healthcare | Completed | Met primary |
| Phase 3 | NCT02777229 | Jul 2016 → Jul 2018 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT02429791 | Apr 2015 → Sep 2016 | HIV infectious disease | ViiV Healthcare | Completed | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT01568892 | Apr → Oct 2012 | HIV infectious disease | ViiV Healthcare | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT01328041 | May 2011 → May 2012 | HIV infectious disease | ViiV Healthcare | Completed | Met primary |
| Phase 3 | NCT01263015 | Feb 2011 → May 2012 | HIV infectious disease | ViiV Healthcare | Completed | Met primary |
| Phase 3 | NCT01231516 | Oct 2010 → Feb 2013 | HIV infectious disease | ViiV Healthcare | Completed | Met primary |
| Phase 3 | NCT01227824 | Oct 2010 → Feb 2012 | HIV infectious disease | ViiV Healthcare | Completed | Met primary |
| Phase 3 | NCT00796263 | May 2009 → Jun 2033 expected | HIV infectious disease | SEARCH Research Foundation | Recruiting | No outcome recorded |
| Phase 444 trials · 5 met primary · 3 missed | ||||||
| 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 | Missed primary |
| Phase 4 | NCT04884139 | Jul 2021 → Feb 2024 | HIV infectious disease | Fundacion SEIMC-GESIDA | Completed | Met primary |
| 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 Stop: Enrollment |
| Phase 4 | NCT04229290 | Feb 2020 → Sep 2021 | HIV infectious disease | University of Nairobi | Completed | Met primary |
| 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 Stop: Enrollment |
| Phase 4 | NCT03683524 | Nov 2018 → Aug 2021 | HIV infectious disease | Fight AIDS and Infectious Diseases Foundation | Completed | Missed primary |
| 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 | Met primary |
| 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 Stop: Enrollment |
| Phase 4 | NCT02924389 | Sep 2016 → Sep 2019 | HIV infectious disease | Emory University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02519777 | Apr 2016 → Dec 2019 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| 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 | NCT02401828 | Mar 2015 → Jun 2017 | HIV infectious disease | Erasmus Medical Center | Completed | Met primary |
| Phase 4 | NCT02351908 | Mar 2015 → Apr 2016 | HIV infectious disease | St Stephens Aids Trust | 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 | Met primary |
| 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 |
| Comparator or background therapy59 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 1/2 | 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 2 | NCT07816250 Comparator | Oct 2026 → Jun 2032 expected | HIV infectious disease | ViiV Healthcare | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05652478 Comparator | Sep 2026 → Jan 2028 expected | — | 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 Stop: Business |
| 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 | tuberculosis | The HIV Netherlands Australia Thailand Research Collaboration | Completed | 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 2/3 | 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 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 | Met primary |
| Phase 3 | NCT05154747 Comparator | Jun 2023 → Mar 2025 | HIV infectious disease | University College, London | Unknown | Met primary |
| Phase 3 | NCT05546242 Comparator | Dec 2022 → Apr 2025 | HIV infectious disease | MRC/UVRI and LSHTM Uganda Research Unit | Completed | 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 | Met primary |
| Phase 3 | NCT03547908 Comparator | May 2018 → Feb 2022 | — | Gilead Sciences | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT02616783 Comparator | Dec 2015 → Feb 2018 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02605954 Comparator | Nov 2015 → Jun 2017 | HIV infectious disease | Gilead Sciences | Completed | Missed primary |
| Phase 3 | NCT02607956 Comparator | Nov 2015 → May 2017 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02469246 Background | Jun 2015 → Dec 2017 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| 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 | Met primary |
| Phase 4 | NCT07673965 Comparator | Oct 2026 → Aug 2027 expected | HIV infectious disease | University of Witwatersrand, South Africa | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07616739 Comparator | Sep 2026 → Oct 2028 expected | HIV infectious disease | Fundación Huésped | 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 | Met primary |
| 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 | Missed primary |
| Phase 4 | NCT04553081 Comparator | May 2020 → Mar 2026 | HIV infectious disease | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT04295460 Background | Mar 2020 → Jan 2022 | HIV infectious disease | Hospitales Universitarios Virgen del Rocío | Unknown | Missed primary |
| Phase 4 | NCT04054089 Comparator | Jan 2020 | HIV infectious disease | Cristina Mussini | Completed | Missed primary |
| 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 |
| — | 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 |
| — | NCT02028819 Background | Jan 2012 → Feb 2014 | HIV infectious disease | University of Colorado, Denver | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 109
| Date | Issuer | Release |
|---|---|---|
| 2026-08-26 | ViiV Healthcare | Regulatory U.S. FDA APPROVES ViiV HEALTHCARE’S TIVICAY PD, HELPING CLOSE A CRITICAL HIV TREATMENT GAP FOR YOUNG CHILDREN viivhealthcare.com ↗
Approval makes Tivicay PD the first second-generation integrase inhibitor approved for children living with HIV weighing at least 2 kg, including eligible newborns |
| 2026-07-29 | GlaxoSmithKline | Results Cabenuva demonstrates superiority to daily oral therapy in adolescents living with HIV, as ViiV Healthcare highlights new long-acting injectable data at AIDS 2026 gsk.com ↗
Confirmed viral rebound occurred in 0.9% (n=2/235) of adolescents receiving CAB+RPV LA versus 6.4% (n=15/241) receiving daily oral therapy. |
| 2026-07-29 | ViiV Healthcare | Results CABENUVA DEMONSTRATES SUPERIORITY TO DAILY ORAL THERAPY IN ADOLESCENTS LIVING WITH HIV, AS ViiV HEALTHCARE HIGHLIGHTS NEW LONG-ACTING INJECTABLE DATA AT AIDS 2026 viivhealthcare.com ↗
Week 96 results from the LATA trial, led by University College London, showed CAB+RPV LA dosed every two months was superior to daily oral dolutegravir/tenofovir disoproxil fumarate/lamivudine (DTG/TDF/3TC) in 476 virologically suppressed adolescents aged 12 to 19 years living with HIV in Kenya, South Africa, Uganda and Zimbabwe. |
| 2026-07-27 | GlaxoSmithKline | Results ViiV Healthcare’s 2-drug regimen Dovato is as effective as 3-drug regimen Biktarvy in first-of-its-kind head-to-head study in treatment-naïve adults living with HIV gsk.com ↗
Data show that Dovato (dolutegravir/lamivudine (DTG/3TC)) demonstrated non-inferior efficacy to Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)) in treatment-naïve adults living with HIV, including people with high viral loads or a low CD4+ cell count1. |
| 2026-07-27 | ViiV Healthcare | Results ViiV HEALTHCARE’S 2-DRUG REGIMEN DOVATO IS AS EFFECTIVE AS 3-DRUG REGIMEN BIKTARVY IN FIRST-OF-ITS-KIND HEAD-TO-HEAD STUDY IN TREATMENT-NAÏVE ADULTS LIVING WITH HIV viivhealthcare.com ↗
Data show that Dovato (dolutegravir/lamivudine (DTG/3TC)) demonstrated non-inferior efficacy to Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF)) in treatment-naïve adults living with HIV, including people with high viral loads or a low CD4+ cell count. |
| 2026-07-21 | ViiV Healthcare | Results ViiV HEALTHCARE TO PRESENT PHASE IIIB DATA COMPARING DOVATO WITH BIKTARVY IN TREATMENT-NAÏVE ADULTS; ALONGSIDE INSTI-POWERED LONG-ACTING INJECTABLE INNOVATION AT AIDS 2026 viivhealthcare.com ↗
Dolutegravir Markedly Improves 6- and 12-Month Viral Suppression in Children ≤5 Years, South Africa |
| 2026-06-22 | ViiV Healthcare | Regulatory ViiV HEALTHCARE ADVANCES PAEDIATRIC HIV REGULATORY SUBMISSIONS WITH FDA PRIORITY REVIEW FOR TIVICAY PD AND EMA VALIDATION OF MARKETING APPLICATION FOR TIVICAY viivhealthcare.com ↗
The FDA has granted Priority Review for this application and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 25, 2026. |
| 2026-05-11 | ViiV Healthcare | Regulatory ViiV HEALTHCARE AIMS TO CLOSE TREATMENT GAPS FOR CHILDREN LIVING WITH HIV WITH PAEDIATRIC DOVATO MARKETING APPLICATIONS TO THE EMA AND FDA viivhealthcare.com ↗
A New Drug Application was also submitted to the U.S. Food and Drug Administration (FDA) as part of ViiV Healthcare’s commitment to help address longstanding gaps in HIV treatment options for children living with HIV. |
| 2026-02-23 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES DATA SHOWING SWITCHING TO DOVATO WAS ASSOCIATED WITH A LOWER PROPORTION OF STEATOTIC LIVER DISEASE VERSUS BIKTARVY FOR HIV-1 TREATMENT viivhealthcare.com ↗
Steatotic liver disease, an increasingly recognised comorbidity in people living with HIV, was reported in 49% (n=26/53) of participants switching to BIC/FTC/TAF versus 29% (n=17/58) switching to DTG/3TC |
| 2025-07-14 | GlaxoSmithKline | Results ViiV Healthcare data show 89% of treatment-naïve people with HIV choose to switch to long-acting injectable Vocabria + Rekambys from daily pills after achieving rapid viral suppression gsk.com ↗ |
| 2025-07-14 | ViiV Healthcare | Results ViiV HEALTHCARE DATA SHOW 89% OF TREATMENT-NAÏVE PEOPLE WITH HIV CHOOSE TO SWITCH TO LONG-ACTING INJECTABLE VOCABRIA + REKAMBYS FROM DAILY PILLS AFTER ACHIEVING RAPID VIRAL SUPPRESSION viivhealthcare.com ↗ |
| 2025-03-09 | ViiV Healthcare | Results ViiV HEALTHCARE CONTINUES TO DELIVER LONG-ACTING INJECTABLE HIV INNOVATION WITH LATE-BREAKING DATA AND REAL-WORLD INSIGHTS ACROSS PIPELINE AND PORTFOLIO AT CROI 2025 viivhealthcare.com ↗
Dolutegravir Does Not Reduce Levonorgestrel or Medroxyprogesterone Acetate Concentrations in WLWH |
| 2024-11-12 | Gilead Sciences | Results Scientific Leadership Spotlighted as Gilead Presents Research Data Across Its Broad and Innovative HIV Treatment Portfolio and Pipeline gilead.com ↗
Major INSTI resistance mutations were selected in 33 cases (26.6%): 28 cases with DTG failure, 3 with BIC and 2 with CAB. |
| 2024-11-11 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES DATA DEMONSTRATING DOVATO (DTG/3TC) IS HIGHLY EFFECTIVE IN TREATMENT-NAIVE PEOPLE WITH ADVANCED HIV viivhealthcare.com ↗
A post-hoc analysis of the study showed DTG/3TC was non-inferior to 3-drug therapy regardless of the participant’s baseline viral load. |
| 2024-11-07 | ViiV Healthcare | Results ViiV HEALTHCARE EXPANDS ON REAL-WORLD DATA SUPPORTING USE OF LONG-ACTING THERAPIES IN DIVERSE PATIENT POPULATIONS AT HIV GLASGOW viivhealthcare.com ↗
Dolutegravir-based antiretroviral therapy does not reduce plasma levonorgestrel or medroxyprogesterone acetate concentrations among contraceptive users living with HIV compared with HIV-negative controls |
| 2024-10-10 | ViiV Healthcare | Results GSK AND ViiV HEALTHCARE TO SHOWCASE ADVANCES ACROSS INDUSTRY-LEADING INFECTIOUS DISEASE PORTFOLIO AT IDWEEK 2024 viivhealthcare.com ↗
Similar Efficacy, Safety and CD4 T-cell Increase up to Week 96 Observed with Fostemsavir (FTR)-Based Regimens in the BRIGHTE Study and Dolutegravir (DTG)-Based Regimens in the VIKING-3 Study in Individuals with Multidrug-Resistant (MDR) HIV-1 |
| 2024-07-23 | GlaxoSmithKline | Results ViiV Healthcare announces positive data demonstrating 2-drug regimen Dovato is as effective as 3-drug regimen Biktarvy for maintenance therapy of HIV-1 gsk.com ↗
Findings showed that switching to DTG/3TC in virologically suppressed adults living with HIV demonstrated non-inferior efficacy in maintaining viral suppression compared with switching to BIC/FTC/TAF. |
| 2024-07-23 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES POSITIVE DATA DEMONSTRATING 2-DRUG REGIMEN DOVATO IS AS EFFECTIVE AS 3-DRUG REGIMEN BIKTARVY FOR MAINTENANCE THERAPY OF HIV-1 viivhealthcare.com ↗
Findings showed that switching to DTG/3TC in virologically suppressed adults living with HIV demonstrated non-inferior efficacy in maintaining viral suppression compared with switching to BIC/FTC/TAF. |
| 2024-02-28 | GlaxoSmithKline | Results ViiV Healthcare to present data for its next generation of ultra long-acting treatments for HIV gsk.com ↗
A single once-daily ABC/DTG/3TC tablet predicts safe and effective exposures in children 3 to <6kg |
| 2023-09-14 | Halcygen Pharmaceuticals Limited | Regulatory Strides receives tentative USFDA approval for Dolutegravir tablets strides.com ↗ |
| 2023-09-05 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Regulatory 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 ↗
The FDA's tentative approval through the President's Emergency Plan for AIDS Relief (PEPFAR) program means the formulation meets all the agency's quality, safety, and efficacy standards. |
| 2023-07-04 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Dolutegravir Tablets for Oral Suspension lupin.com ↗ |
| 2022-03-30 | GlaxoSmithKline | Regulatory ViiV Healthcare announces US FDA approval of Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV gsk.com ↗ |
| 2022-03-30 | ViiV Healthcare | Regulatory ViiV HEALTHCARE ANNOUNCES US FDA APPROVAL OF TRIUMEQ PD, THE FIRST DISPERSIBLE SINGLE TABLET REGIMEN CONTAINING DOLUTEGRAVIR, A ONCE-DAILY TREATMENT FOR CHILDREN LIVING WITH HIV viivhealthcare.com ↗ |
| 2021-10-04 | GlaxoSmithKline | Regulatory ViiV Healthcare submits FDA application for first dispersible single tablet regimen containing dolutegravir (DTG) for children living with HIV gsk.com ↗ |
| 2021-10-04 | ViiV Healthcare | Regulatory ViiV Healthcare submits FDA application for first dispersible single tablet regimen containing dolutegravir (DTG) for children living with HIV viivhealthcare.com ↗ |
| 2021-09-29 | GlaxoSmithKline | Results ViiV Healthcare presents three-year switch data for Dovato (dolutegravir/lamivudine) confirming long-term, non-inferior efficacy with no virologic failure versus continuation of TAF-based regimens of at least three drugs gsk.com ↗
At three years, no participants on dolutegravir/lamivudine (0% [0/369]) met confirmed protocol-defined virologic failure, versus three participants (<1% [3/372]) on the TAF-based regimen. |
| 2021-09-29 | ViiV Healthcare | Results ViiV Healthcare presents three-year switch data for Dovato (dolutegravir/lamivudine) confirming long-term, non-inferior efficacy with no virologic failure versus continuation of TAF-based regimens of at least three drugs viivhealthcare.com ↗
At three years, no participants on dolutegravir/lamivudine (0% [0/369]) met confirmed protocol-defined virologic failure, versus three participants (<1% [3/372]) on the TAF-based regimen. |
| 2021-07-17 | GlaxoSmithKline | Results ViiV Healthcare to present new data from diverse portfolio and pipeline of 2-drug and long-acting regimens for HIV treatment and prevention at IAS 2021 gsk.com ↗
After three years of therapy, dolutegravir/lamivudine maintained non-inferior virologic efficacy compared with a TBR, with no confirmed virologic withdrawals or resistance development noted in the dolutegravir/lamivudine treatment arm. |
| 2021-07-17 | GlaxoSmithKline | Results ViiV Healthcare presents data from second Dovato (dolutegravir/lamivudine) switch study confirming non-inferior efficacy and no virologic failure versus a broad range of regimens of at least 3 drugs gsk.com ↗
The 2-drug regimen (2DR) Dovato (dolutegravir/lamivudine) demonstrated non-inferior efficacy compared to continuation of a current antiretroviral regimen (CAR) of at least three drugs*, with zero cases of virologic failure and no development of resistance |
| 2021-07-17 | ViiV Healthcare | Results ViiV Healthcare to present new data from diverse portfolio and pipeline of 2-drug and long-acting regimens for HIV treatment and prevention at IAS 2021 viivhealthcare.com ↗
The occurrence of any elevated viral loads above 50 copies/mL was lower in the dolutegravir/lamivudine arm (6%) versus the TBR arm (10%). |
| 2021-07-17 | ViiV Healthcare | Results ViiV Healthcare presents data from second Dovato (dolutegravir/lamivudine) switch study confirming non-inferior efficacy and no virologic failure versus a broad range of regimens of at least 3 drugs viivhealthcare.com ↗
The 48-week data from the phase III SALSA study represent a diverse patient population, and demonstrate comparable safety for 2-drug regimen Dovato versus continuation of a current antiretroviral regimen of at least 3 drugs, reinforcing its use in a switch setting |
| 2021-01-13 | GlaxoSmithKline | Regulatory ViiV Healthcare receives EU Marketing Authorisation for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in Europe gsk.com ↗ |
| 2021-01-13 | ViiV Healthcare | Regulatory ViiV Healthcare receives EU Marketing Authorisation for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in Europe viivhealthcare.com ↗
ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Commission has granted Marketing Authorisation for Tivicay (dolutegravir) 5mg dispersible tablets, which are used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in paediatric patients (treatment-naïve or -experienced but INSTI-naïve) aged at least four weeks and weighing at least 3kg. |
| 2020-11-23 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Regulatory Viatris Inc. Announces FDA Tentative Approval of a Pediatric Formulation of Dolutegravir (DTG) Under PEPFAR viatris.com ↗
Viatris Inc. (NASDAQ: VTRS), a new kind of healthcare company, today announced tentative approval from the U.S. Food and Drug Administration (FDA) for a New Drug Application for pediatric dolutegravir tablets for oral suspension, 10 mg. |
| 2020-11-13 | GlaxoSmithKline | Regulatory ViiV Healthcare announces CHMP positive opinion for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in Europe gsk.com ↗ |
| 2020-11-13 | ViiV Healthcare | Regulatory ViiV Healthcare announces CHMP positive opinion for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in Europe viivhealthcare.com ↗
This CHMP positive opinion paves the way to expand the use of dolutegravir in a younger population because this tablet can be dispersed in water, making it much easier for a child to take their medication. |
| 2020-10-08 | GlaxoSmithKline | Results ViiV Healthcare presents long-term switch data for Dovato demonstrating non-inferior efficacy in adults with HIV-1 and zero cases of virologic failure versus continuation of a 3-drug TAF-based regimen gsk.com ↗
Data from the study revealed that no participants on Dovato (0/369, 0%) and three participants (3/372, <1%) on the TAF-based regimen met protocol-defined virologic failure, and no participants developed resistance mutations upon failure. |
| 2020-10-08 | ViiV Healthcare | Results ViiV HEALTHCARE PRESENTS LONG-TERM SWITCH DATA FOR DOVATO DEMONSTRATING NON-INFERIOR EFFICACY IN ADULTS WITH HIV-1 AND ZERO CASES OF VIROLOGIC FAILURE VERSUS CONTINUATION OF A 3-DRUG TAF-BASED REGIMEN viivhealthcare.com ↗
Data from the study revealed that no participants on Dovato (0/369, 0%) and three participants (3/372, <1%) on the TAF-based regimen met protocol-defined virologic failure, and no participants developed resistance mutations upon failure. |
| 2020-10-05 | GlaxoSmithKline | Results ViiV Healthcare announces dolutegravir plus lamivudine three-year data confirming long-term viral suppression non-inferior to a 3-drug regimen for treatment-naïve adults with HIV-1 gsk.com ↗
Dolutegravir plus lamivudine continues to demonstrate long-term non-inferior efficacy compared to dolutegravir plus TDF/FTC with benefits beyond viral suppression. |
| 2020-10-05 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES DOLUTEGRAVIR PLUS LAMIVUDINE THREE-YEAR DATA CONFIRMING LONG-TERM VIRAL SUPPRESSION NON-INFERIOR TO A 3-DRUG REGIMEN FOR TREATMENT-NAÏVE ADULTS WITH HIV-1 viivhealthcare.com ↗
Dolutegravir plus lamivudine continues to demonstrate long-term non-inferior efficacy compared to dolutegravir plus TDF/FTC with benefits beyond viral suppression. |
| 2020-08-20 | ViiV Healthcare | Results ViiV Healthcare announces data demonstrating the feasibility of Dovato (dolutegravir/lamivudine) as a treatment option for rapid initiation after diagnosis in adults with HIV-1 viivhealthcare.com ↗
Dovato was found to be effective and well tolerated in this setting, indicating the feasibility of its use in Test and Treat strategies. |
| 2020-07-02 | GlaxoSmithKline | Results ViiV Healthcare to present new data on long-acting regimens for HIV prevention and treatment, alongside extensive insights into the evolving needs of people living with HIV at 23rd International AIDS Conference (AIDS 2020: Virtual) gsk.com ↗
Improved metabolic parameters after switching from TAF-based 3- or 4-drug regimen to the 2-drug regimen of DTG/3TC (dolutegravir/lamivudine): the TANGO study |
| 2020-07-02 | ViiV Healthcare | Results ViiV Healthcare to present new data on long-acting regimens for HIV prevention and treatment, alongside extensive insights into the evolving needs of people living with HIV at 23rd International AIDS Conference (AIDS 2020: Virtual) viivhealthcare.com ↗
Improved metabolic parameters after switching from TAF-based 3- or 4-drug regimen to the 2-drug regimen of DTG/3TC (dolutegravir/lamivudine): the TANGO study |
| 2020-06-12 | GlaxoSmithKline | Regulatory ViiV Healthcare announces US FDA approval of the first-ever dispersible tablet formulation of dolutegravir, Tivicay PD, a once-daily treatment for children living with HIV gsk.com ↗ |
| 2020-06-12 | ViiV Healthcare | Regulatory ViiV Healthcare announces US FDA approval of the first-ever dispersible tablet formulation of dolutegravir, Tivicay PD, a once-daily treatment for children living with HIV viivhealthcare.com ↗
The FDA approval is testament to the commitments of global stakeholders spanning regulators, industry and non-profit organisations to develop new and innovative HIV medicines for children, most of whom live in resource-poor settings. |
| 2020-03-11 | Janssen Research & Development, LLC | Results Janssen Announces Results of Phase 3 Study Demonstrating the Safety and Efficacy of Long-Acting Injectable HIV Treatment Regimen of Rilpivirine And Cabotegravir through 96 Weeks jnj.com ↗
The study – First Long-Acting Injectable Regimen (FLAIR) trial – demonstrated positive 96-week results in long-term safety and efficacy of rilpivirine and cabotegravir. |
| 2020-01-15 | GlaxoSmithKline | Regulatory Dovato (dolutegravir/lamivudine), the once-daily, single-pill, 2-drug regimen for the treatment of HIV-1 infection, granted marketing approval by Japan Ministry of Health, Labour and Welfare gsk.com ↗
With the authorisation of Dovato, people living with HIV in Japan can - for the first time - start treatment on a once-daily, single-pill, 2-drug regimen with the knowledge that efficacy is non-inferior to a three-drug regimen. |
| 2020-01-15 | ViiV Healthcare | Regulatory Dovato (dolutegravir/lamivudine), the once-daily, single-pill, 2-drug regimen for the treatment of HIV-1 infection, granted marketing approval by Japan Ministry of Health, Labour and Welfare viivhealthcare.com ↗
The authorisation of Dovato in Japan marks a significant development for people living with HIV. |
| 2019-12-13 | GlaxoSmithKline | Regulatory ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir (DTG) for children living with HIV gsk.com ↗ |
| 2019-12-13 | ViiV Healthcare | Regulatory ViiV Healthcare files submissions to the FDA and EMA for the first-ever dispersible formulation of dolutegravir (DTG) for children living with HIV viivhealthcare.com ↗ |
| 2019-11-06 | Gilead Sciences | Results Gilead’s Biktarvy Maintained High Efficacy With No Cases of Treatment-Emergent Resistance Through Three Years in Phase 3 HIV Clinical Trials gilead.com ↗
Across all treatment groups no participants developed treatment failure with treatment-emergent resistance. |
| 2019-07-24 | GlaxoSmithKline | Results ViiV Healthcare presents GEMINI 1 & 2 studies through Week 96 showing 2-drug regimen of dolutegravir plus lamivudine continues to demonstrate high efficacy rates and no cases of treatment emergent resistance gsk.com ↗
Both the GEMINI 1 & 2 studies showed that dolutegravir plus lamivudine continued to offer non-inferior efficacy to dolutegravir plus TDF/FTC at Week 96. |
| 2019-07-24 | GlaxoSmithKline | Results ViiV Healthcare announces positive Week 48 results in first study to evaluate treatment switch from TAF-containing regimen with three or more drugs to 2-drug regimen of dolutegravir/lamivudine for HIV-1 infection gsk.com ↗
Today ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced that data from the phase III TANGO study showed that the 2-drug regimen (2DR) of Dovato▼ (dolutegravir/lamivudine) has similar efficacy to a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs in virally supressed and stable adults with HIV-1. |
| 2019-07-24 | ViiV Healthcare | Results ViiV HEALTHCARE PRESENTS GEMINI 1 & 2 STUDIES THROUGH WEEK 96 SHOWING 2-DRUG REGIMEN OF DOLUTEGRAVIR PLUS LAMIVUDINE CONTINUES TO DEMONSTRATE HIGH EFFICACY RATES AND NO CASES OF TREATMENT EMERGENT RESISTANCE viivhealthcare.com ↗
Both the GEMINI 1 & 2 studies showed that dolutegravir plus lamivudine continued to offer non-inferior efficacy to dolutegravir plus TDF/FTC at Week 96. |
| 2019-07-24 | ViiV Healthcare | Results ViiV Healthcare announces positive Week 48 results in first study to evaluate treatment switch from TAF-containing regimen with three or more drugs to 2-drug regimen of dolutegravir/lamivudine for HIV-1 infection viivhealthcare.com ↗
Today ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced that data from the phase III TANGO study showed that the 2-drug regimen (2DR) of Dovato▼ (dolutegravir/lamivudine) has similar efficacy to a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs in virally suppressed adults with HIV-1. |
| 2019-07-10 | GlaxoSmithKline | Results ViiV Healthcare announces phase III study meets primary endpoint, demonstrating the ability to control HIV-1 with a 2-drug regimen of dolutegravir plus lamivudine in virally suppressed patients switching from a TAF-containing, 3-drug regimen gsk.com ↗
The study met its primary endpoint for non-inferiority, based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre (c/mL) using the FDA Snapshot algorithm at Week 48. |
| 2019-07-10 | ViiV Healthcare | Results ViiV Healthcare announces phase III study meets primary endpoint, demonstrating the ability to control HIV-1 with a 2-drug regimen of dolutegravir plus lamivudine in virally suppressed patients switching from a TAF-containing, 3-drug regimen viivhealthcare.com ↗
The study met its primary endpoint for non-inferiority, based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre (c/mL) using the FDA Snapshot algorithm at Week 48. |
| 2019-07-03 | GlaxoSmithKline | Regulatory ViiV Healthcare receives EU Marketing Authorisation for Dovato (dolutegravir/lamivudine), a new once-daily, single-pill, two-drug regimen for the treatment of HIV-1 infection gsk.com ↗ |
| 2019-07-03 | ViiV Healthcare | Regulatory ViiV HEALTHCARE RECEIVES EU MARKETING AUTHORISATION FOR DOVATO (DOLUTEGRAVIR/LAMIVUDINE), A NEW ONCE-DAILY, SINGLE-PILL, TWO-DRUG REGIMEN FOR THE TREATMENT OF HIV-1 INFECTION viivhealthcare.com ↗
London, UK, 3 July 2019 – ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Commission has granted Marketing Authorisation for Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine. |
| 2019-04-27 | ViiV Healthcare | Regulatory ViiV HEALTHCARE ANNOUNCES CHMP POSITIVE OPINION FOR DOVATO® (DOLUTEGRAVIR/LAMIVUDINE) AS A ONCE-DAILY, SINGLE-PILL, TWO-DRUG REGIMEN FOR THE TREATMENT OF HIV INFECTION viivhealthcare.com ↗ |
| 2019-04-26 | GlaxoSmithKline | Regulatory ViiV Healthcare announces CHMP Positive Opinion for Dovato® (dolutegravir/lamivudine) as a once-daily, single-pill, two-drug regimen for the treatment of HIV infection gsk.com ↗
Today’s CHMP Positive Opinion for Dovato is an important step towards providing treatment-naïve people living with HIV in Europe the first once-daily, single-pill, complete 2-drug regimen for the treatment of HIV. |
| 2019-04-09 | ViiV Healthcare | Regulatory US FDA APPROVES ViiV HEALTHCARE’S DOVATO (DOLUTEGRAVIR/LAMIVUDINE), THE FIRST, ONCE-DAILY, SINGLE-TABLET, TWO-DRUG REGIMEN FOR TREATMENT-NAÏVE HIV-1 ADULTS viivhealthcare.com ↗ |
| 2019-04-08 | GlaxoSmithKline | Regulatory US FDA approves ViiV Healthcare’s Dovato (dolutegravir/lamivudine), the first, once-daily, single-tablet, two-drug regimen for treatment-naïve HIV-1 adults gsk.com ↗
ViiV Healthcare today announced that the US Food and Drug Administration (FDA) approved Dovato, a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either DTG or 3TC. |
| 2019-04-04 | ViiV Healthcare | Results ViiV HEALTHCARE ANNOUNCES JULUCA (DOLUTEGRAVIR/RILPIVIRINE) MAINTAINS HIV VIRAL SUPPRESSION AT 148-WEEKS viivhealthcare.com ↗
With the SWORD data we now have three year data showing the excellent effectiveness and tolerability of Juluca, the first approved dolutegravir-based 2-drug regimen. |
| 2019-04-03 | GlaxoSmithKline | Results ViiV Healthcare announces Juluca (dolutegravir/rilpivirine) maintains HIV viral suppression at 148-weeks gsk.com ↗
ViiV Healthcare today presented three year results from the SWORD 1 & 2 studies, demonstrating that 84% (432/513) of participants who switched from their current three- or four-drug antiretroviral regimen to a 2-drug regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen Sciences Ireland UC, part of the Janssen Pharmaceutical Companies of Johnson & Johnson) maintained viral suppression (viral load ≤50 copies/mL). |
| 2019-03-07 | GlaxoSmithKline | Results ViiV Healthcare presents positive, 48-week data from two pivotal phase III studies showing long-acting, injectable two-drug regimen of cabotegravir and rilpivirine has similar efficacy to daily, three-drug oral treatment in adults living with HIV-1 infection gsk.com ↗
The study found virologic suppression rates (HIV-1 RNA <50 c/mL) at Week 48 were similar between treatment arms (cabotegravir + rilpivirine: 265/283 [93.6%], Triumeq: 264/283 [93.3%], adjusted difference: 0.4%. 95% CI: -3.7, 4.5). |
| 2019-03-07 | ViiV Healthcare | Results ViiV HEALTHCARE PRESENTS POSITIVE, 48-WEEK DATA FROM TWO PIVOTAL PHASE III STUDIES SHOWING LONG-ACTING, INJECTABLE TWO-DRUG REGIMEN OF CABOTEGRAVIR AND RILPIVIRINE HAS SIMILAR EFFICACY TO DAILY, THREE-DRUG ORAL TREATMENT IN ADULTS LIVING WITH HIV-1 INFECTION viivhealthcare.com ↗
The study found virologic suppression rates (HIV-1 RNA <50 c/mL) at Week 48 were similar between treatment arms (cabotegravir + rilpivirine: 265/283 [93.6%], Triumeq: 264/283 [93.3%], adjusted difference: 0.4%. 95% CI: -3.7, 4.5). |
| 2018-11-26 | GlaxoSmithKline | Regulatory Juluca (dolutegravir/rilpivirine), the first single pill, 2-drug regimen, for the maintenance treatment of HIV, granted marketing approval by Japan Ministry of Health, Labour and Welfare gsk.com ↗
This regulatory approval demonstrates our commitment to bringing new medicines for people living with HIV, as they now have the opportunity to maintain their viral suppression with only two drugs within a single-pill. |
| 2018-11-16 | GlaxoSmithKline | Regulatory ViiV Healthcare receives CHMP Positive Opinion for Tivicay EU label update with GEMINI study data for the 2-drug regimen of Tivicay + lamivudine gsk.com ↗
This CHMP Positive Opinion provides further support for the efficacy of dolutegravir in treating HIV as a 2-drug regimen (2DR). |
| 2018-10-30 | GlaxoSmithKline | Results ViiV Healthcare reports positive 48-week results for second phase III study for novel, long-acting, injectable HIV-treatment regimen gsk.com ↗
The study showed long-acting cabotegravir and rilpivirine, injected once a month, had similar efficacy to Triumeq at Week 48 based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre [c/mL] using the FDA Snapshot algorithm. |
| 2018-10-30 | Gilead Sciences | Results Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy gilead.com ↗
In the ongoing study, Biktarvy was found to be statistically non-inferior to a regimen of dolutegravir and emtricitabine/tenofovir alafenamide (50 mg) (DTG+FTC/TAF) through 96 weeks of therapy. |
| 2018-10-18 | GlaxoSmithKline | Regulatory ViiV Healthcare submits New Drug Application to US FDA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV gsk.com ↗
ViiV Healthcare today announced it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for a single-tablet, two-drug regimen of dolutegravir (DTG) and lamivudine (3TC) for the treatment of HIV-1 infection. |
| 2018-10-03 | Gilead Sciences | Results Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy gilead.com ↗
In the ongoing study, Biktarvy was found to be statistically non-inferior to a regimen of abacavir/dolutegravir/lamivudine (600/50/300mg, ABC /DTG/3TC) through 96 weeks of therapy. |
| 2018-09-14 | GlaxoSmithKline | Regulatory ViiV Healthcare submits regulatory application to European Medicines Agency for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV gsk.com ↗
London, UK ViiV Healthcare today announced submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for a single-tablet, two-drug regimen of dolutegravir (DTG) and lamivudine (3TC) for the treatment of HIV-1 infection. |
| 2018-07-24 | GlaxoSmithKline | Results ViiV Healthcare presents phase III data at AIDS 2018 from landmark GEMINI studies showing two-drug regimen of dolutegravir and lamivudine has similar efficacy to a three-drug regimen in treatment naïve HIV patients, with no emergence of resistance gsk.com ↗
The studies met their primary endpoint for non-inferiority based on plasma HIV-1 RNA <50c/mL, a standard measure of HIV control, at Week 48. |
| 2018-07-24 | GlaxoSmithKline | Results ViiV Healthcare announces SWORD 100-week data for Juluca (dolutegravir/rilpivirine) at AIDS 2018 gsk.com ↗
The results confirm the ability of Juluca to maintain efficacy over a 100-week period and importantly support that the long-term safety profile of this regimen is consistent with the respective labels of the component medicines. |
| 2018-06-14 | GlaxoSmithKline | Results ViiV Healthcare reports landmark phase III studies for dolutegravir and lamivudine, demonstrating the ability to control HIV with a two-drug regimen in treatment naïve patients gsk.com ↗
The studies met their primary endpoint for non-inferiority based on plasma HIV-1 RNA <50 copies per millilitre (c/mL), a standard measure of HIV control, at Week 48. |
| 2018-05-21 | GlaxoSmithKline | Regulatory ViiV Healthcare receives EU marketing authorisation for Juluca (dolutegravir/rilpivirine), the first 2-drug regimen, once-daily, single-pill for the treatment of HIV gsk.com ↗
This approval brings another treatment option to the estimated 810,000 PLHIV in Europe. |
| 2018-03-23 | GlaxoSmithKline | Regulatory ViiV Healthcare gains CHMP positive opinion for Juluca (dolutegravir/rilpivirine) in Europe gsk.com ↗
today announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a Positive Opinion recommending marketing authorisation for Juluca (dolutegravir/rilpivirine) |
| 2018-03-05 | GlaxoSmithKline | Results ViiV Healthcare announces positive new dolutegravir data for the treatment of people living with HIV co-infected with tuberculosis gsk.com ↗
Results presented today at the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, show that dolutegravir when administered at 50mg twice-daily with dual nucleoside reverse transcriptase inhibitors (NRTI), was effective and well-tolerated in HIV/TB co-infected adults receiving rifampin-based TB therapy. |
| 2018-03-05 | Gilead Sciences | Results 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 ↗
Through Week 48, Biktarvy was found to be statistically non-inferior to ABC /DTG/3TC with a numerically lower incidence of mild or moderate study drug-related adverse events and no treatment-emergent resistance. |
| 2017-11-21 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of First and Only Complete, Single-Pill, Two-Drug Regimen, JULUCA® (Dolutegravir and Rilpivirine), for the Treatment of HIV-1 In jnj.com ↗
“Today’s approval of JULUCA® marks a significant milestone in the treatment of HIV,” said Brian Woodfall, Global Head of Late Development, Janssen Research & Development. |
| 2017-11-21 | GlaxoSmithKline | Regulatory Juluca® (dolutegravir and rilpivirine) approved in US as first 2-drug regimen, once-daily, single pill - a complete regimen for the maintenance treatment of virologically suppressed HIV-1 infection gsk.com ↗
The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care. |
| 2017-07-25 | GlaxoSmithKline | Results ViiV Healthcare announces superior efficacy of dolutegravir versus lopinavir/ritonavir in second-line HIV treatment in resource-limited settings gsk.com ↗
The 24-week interim data showed an 82% response rate in the dolutegravir arm versus 69% for lopinavir/ritonavir (p<0.001). |
| 2017-07-25 | GlaxoSmithKline | Results Switching to a dolutegravir regimen from a boosted protease inhibitor regimen maintained viral suppression and improved lipid fractions in patients with HIV and high cardiovascular risk gsk.com ↗
The study demonstrated that switching to a dolutegravir-based regimen in virologically suppressed HIV-infected patients with high CVD risk was non-inferior compared with continuing a boosted PI-based regimen, with no emergent resistance mutations in any of the groups. |
| 2017-07-24 | Gilead Sciences | Results Gilead Announces Phase 3 Results for Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV gilead.com ↗
In the ongoing studies, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing dolutegravir (50mg) (DTG) in combination with a dual-NRTI backbone. |
| 2017-06-01 | GlaxoSmithKline | Regulatory ViiV Healthcare submits regulatory applications for the first HIV maintenance regimen comprising only two medicines gsk.com ↗ |
| 2017-02-13 | GlaxoSmithKline | Results ViiV Healthcare announces detailed positive phase III results for investigational two-drug regimen of dolutegravir and rilpivirine for HIV treatment gsk.com ↗
Virologic suppression rates were similar between treatment arms. |
| 2017-02-13 | Gilead Sciences | Results Gilead Presents New Phase 2 Data on Bictegravir, an Investigational Integrase Strand Transfer Inhibitor for the Treatment of HIV gilead.com ↗
Results found that the BIC+FTC/TAF and DTG+FTC/TAF regimens both demonstrated high virologic response rates at Week 24 and Week 48. |
| 2016-12-19 | GlaxoSmithKline | Results ViiV Healthcare announces positive results from first phase III studies of two-drug HIV treatment regimen gsk.com ↗ |
| 2016-12-16 | GlaxoSmithKline | Regulatory ViiV Healthcare Announces CHMP positive opinion to lower the age and weight limit for Tivicay® (dolutegravir) in children and adolescents living with HIV in Europe gsk.com ↗ |
| 2016-07-18 | GlaxoSmithKline | Results ARIA study shows superior efficacy of Triumeq® for treatment-naïve women living with HIV gsk.com ↗
ViiV Healthcare today presented 48-week data from the phase IIIb, open-label, international, multi-centre ARIA study which showed superior efficacy for Triumeq® (dolutegravir/abacavir/lamivudine) compared with atazanavir boosted with ritonavir (ATV/r) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 495 treatment-naïve women living with HIV. |
| 2016-06-10 | GlaxoSmithKline | Regulatory ViiV Healthcare announces FDA approval to lower the weight limit for dolutegravir in children and adolescents living with HIV gsk.com ↗ |
| 2015-09-23 | GlaxoSmithKline | Results New Phase IIIb/IV data show switching to once-daily Triumeq® maintains HIV viral suppression gsk.com ↗
Furthermore, statistically, the treatment satisfaction score improved significantly more for those patients switching to once-daily abacavir/dolutegravir/lamivudine from their established regimen, as assessed by the HIV Treatment Satisfaction Questionnaire (adjusted difference 2.4, 95% CI: 1.3, 3.5; p<0.001). |
| 2014-09-03 | GlaxoSmithKline | Regulatory ViiV Healthcare receives EU marketing authorisation for Triumeq® (dolutegravir/abacavir/lamivudine), a new once-daily single-pill regimen for the treatment of HIV gsk.com ↗
We are delighted with today’s approval that offers people living with HIV in Europe the first single-pill regimen containing dolutegravir. |
| 2014-08-22 | GlaxoSmithKline | Regulatory ViiV Healthcare receives FDA approval for Triumeq® (abacavir, dolutegravir and lamivudine), a new single-pill regimen for the treatment of HIV-1 infection gsk.com ↗
ViiV Healthcare announced today that the US Food and Drug Administration (FDA) has approved Triumeq® (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection. |
| 2014-06-27 | GlaxoSmithKline | Regulatory Triumeq® (dolutegravir/abacavir/lamivudine) single-tablet regimen receives positive CHMP opinion in Europe for the treatment of HIV gsk.com ↗
the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Triumeq® (dolutegravir/abacavir/lamivudine) |
| 2014-01-21 | GlaxoSmithKline | Regulatory ViiV Healthcare’s new HIV medicine TivicayTM (dolutegravir) is approved in Europe gsk.com ↗
ViiV Healthcare today announced that the European Commissionhas approved TivicayTM (dolutegravir), an integrase inhibitor, for use in combination with other anti-retroviral medicinal products for the treatment of HIV infected adults and adolescents above 12 years of age. |
| 2013-11-22 | GlaxoSmithKline | Regulatory Tivicay® (dolutegravir) receives positive CHMP opinion in Europe for the treatment of HIV gsk.com ↗
“We welcome the CHMP’s positive opinion on dolutegravir – it puts us a step closer to offering this new treatment option to people across Europe who are living with HIV,” |
| 2013-10-25 | GlaxoSmithKline | Regulatory ViiV Healthcare announces European regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV gsk.com ↗
ViiV Healthcare today announced the submission of a regulatory application in Europe for its investigational single-tablet regimen (STR) combining dolutegravir (DTG), abacavir (ABC) and lamivudine (3TC) for the treatment of people living with HIV. |
| 2013-10-22 | GlaxoSmithKline | Regulatory ViiV Healthcare announces US regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV gsk.com ↗
ViiV Healthcare today announced the submission of a regulatory application in the United States for its investigational single-tablet regimen (STR) combining dolutegravir, abacavir and lamivudine for the treatment of people living with HIV-1. |
| 2013-09-12 | GlaxoSmithKline | Results ViiV Healthcare Presents Positive Data from Phase IIIb/IV Study of Dolutegravir vs Darunavir in Treatment-Naïve Adults with HIV-1 gsk.com ↗
ViiV Healthcare today announced initial results from the Phase IIIb/IV FLAMINGO (ING114915) study. |
| 2013-08-13 | GlaxoSmithKline | Regulatory ViiV Healthcare announces U.S. approval of Tivicay® (dolutegravir) for the treatment of HIV-1 gsk.com ↗
ViiV Healthcare is pleased to announce today that the U.S. Food and Drug Administration (FDA) has approved Tivicay® (dolutegravir) 50-mg tablets. |
| 2013-03-06 | GlaxoSmithKline | Results ViiV Healthcare presents data from Phase III study of dolutegravir vs raltegravir in treatment-experienced adults with HIV-1 gsk.com ↗
Differences in treatment outcome in favour of the dolutegravir arm were driven by greater virologic response: at Week 24, 15% of patients receiving the dolutegravir regimen had virologic non-response vs. 24% of patients receiving the raltegravir regimen. |
| 2013-02-15 | GlaxoSmithKline | Regulatory ViiV Healthcare announces FDA priority review designation for dolutegravir as a potential treatment for HIV infection gsk.com ↗
ViiV Healthcare today announced that the U.S. Food and Drug Administration (FDA) has granted a priority review designation to dolutegravir submitted for the treatment of HIV infection, in combination with other antiretroviral agents, in adults and adolescents. |
| 2012-07-11 | GlaxoSmithKline | Results Shionogi-ViiV Healthcare announces positive initial data from phase III study of dolutegravir-based regimen vs Atripla in HIV gsk.com ↗
The study demonstrated superiority of the dolutegravir-based regimen compared to the single tablet regimen Atripla®. |
| 2012-04-02 | GlaxoSmithKline | Results Shionogi-ViiV Healthcare announces initial data from pivotal phase III study of dolutegravir in HIV gsk.com ↗
The study met its primary objective, demonstrating non-inferiority of dolutegravir to raltegravir. |
| 2009-07-20 | GlaxoSmithKline | Results Antiviral activity of S/GSK1349572, the only once-daily, unboosted integrase inhibitor in clinical development, evaluated in phase 2 study gsk.com ↗
On day 11, a mean decrease from baseline in plasma HIV-1 RNA levels of 1.5 to 2.5 log10 copies/mL was observed across the doses tested (2mg – 50mg). |
All press releases naming this drug 126 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 126 releases opens the full record — a long page | ||
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 279 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dolutegravir | “Participants on any stable second-generation integrase strand transfer inhibitor-based 3DR regimen with HIV-1 RNA < 50 copies/mL plasma for at least 3 months were randomized to...” PMID 39226296 ↗ Feb 2025235“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 ↗ “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 ↗ |
| 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 ↗ |
| 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 ↗10“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 ↗ “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 ↗ |