Drugs / Darunavir
Darunavir
Regulatory milestones approvals, filings & regulatory actions · 16 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed HIV infectious disease 4 milestones | |||||
| Filed | US (FDA) | — | HIV infectious disease | 2017-10-17 | “submitted to the FDA for apalutamide, an oral androgen receptor inhibitor for men with non-metastatic castration-resistant prostate cancer and also for...” jnj.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2016-09-12 | “Janssen Submits Marketing Authorisation Application for Darunavir-Based Single Tablet Regimen for Treatment of HIV-1 to European Medicines Agency” jnj.com ↗ “submitted to the FDA for sirukumab in rheumatoid arthritis, and to EMA for a darunavir-based single tablet regimen” jnj.com ↗ |
| Filed | US (FDA) | — | HIV infectious disease | 2014-04-01 | “a New Drug Application was submitted to the FDA seeking approval for a once -daily fixed-dose antiretroviral combination tablet containing darunavir” jnj.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | 2013-10-15 | “submitted a Marketing Authorisation Application to the European Medicines Agency seeking approval for a once -daily single tablet fixed-dose antiretroviral combination product...” jnj.com ↗ “Also filed with the EMA, was a once -daily single tablet fixed -dose antiretroviral combination product containing darunavir” jnj.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (10) | US (FDA) | PREZISTA | — | 2008-10-21 – 2019-03-21 | fda.gov ↗ |
| Approved | EU (EMA) | Prezista | — | 2007-02-11 | europa.eu ↗ |
| Approved | US (FDA) | PREZISTA | — | 2006-06-23 | fda.gov ↗ |
Trials 141 · started per year
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US approved 2006
EU approved 2007
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 142 trials · 1 met primary | ||||||
| Phase 1 | NCT05197075 | Aug → Sep 2022 | HIV infectious disease | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05378906 | Jun → Sep 2022 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04718805 | Jan → Mar 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04661397 | Jan → Jul 2021 | — | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 1 | NCT04630002 | Oct 2020 → Oct 2021 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT04236453 | Jan → Apr 2020 | — | Janssen Pharmaceutica N.V., Belgium | Terminated | No outcome recorded |
| Phase 1 | NCT04208061 | Dec 2019 → Mar 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03864406 | Jun 2019 → Dec 2022 | — | National Institutes of Health Clinical Center (CC) | 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 | NCT03472963 | Apr 2018 → Mar 2019 | HIV infectious disease | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT03892161 | Apr → Nov 2018 | HIV infectious disease | University of Cape Town | Terminated | No outcome recorded |
| Phase 1 | NCT03094507 | Apr 2017 → Jan 2018 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 1 | NCT02984852 | Dec 2016 → Feb 2017 | — | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02771249 | Jun 2016 → Aug 2021 | latent tuberculosis infection | National Institutes of Health Clinical Center (CC) | Completed | No outcome recorded |
| Phase 1 | NCT02818348 | Jun → Oct 2016 | HIV infectious disease | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 1 | NCT02589158 | Nov 2015 → Mar 2016 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 1 | NCT02475135 | Jun → Aug 2015 | — | Janssen Sciences Ireland UC | Completed | No outcome recorded |
| Phase 1 | NCT02277600 | Nov 2014 → Jan 2015 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT02489487 | Sep → Oct 2014 | HIV infectious disease | Viriom | Completed | No outcome recorded |
| Phase 1 | NCT02203461 | Jul → Oct 2014 | — | Technical University of Munich | Completed | No outcome recorded |
| Phase 1 | NCT02159352 | Jun → Jul 2014 | hepatitis C virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02063360 | Feb → May 2014 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01695954 | May 2012 → Jan 2013 | HIV infectious disease, hyperlipidemia | NYU Langone Health | Completed | No outcome recorded |
| Phase 1 | NCT01519336 | Feb → Mar 2012 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01348763 | Oct 2011 → Feb 2012 | HIV infectious disease | Imperial College London | Completed | No outcome recorded |
| Phase 1 | NCT01374802 | Jun → Jul 2011 | HIV infectious disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01876966 | Mar → Jul 2011 | HIV infectious disease | Janssen Pharmaceutica N.V., Belgium | Completed | No outcome recorded |
| Phase 1 | NCT01323257 | Mar → Aug 2011 | chronic hepatitis C virus infection | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT01073761 | Apr → Jun 2010 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 1 | NCT01052883 | Mar → Jun 2010 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT00936793 | Jul 2009 → Jun 2011 | HIV infectious disease, asthma | National Institutes of Health Clinical Center (CC) | Completed | No outcome recorded |
| Phase 1 | NCT00855088 | Jul 2009 → Feb 2010 | AIDS | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 1 | NCT00920088 | Jun → Nov 2009 | HIV infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00867152 | Apr → May 2009 | — | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT00838760 | Feb → Oct 2009 | — | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT00854204 | Nov 2008 → Jan 2009 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT00783484 | Oct 2008 → May 2009 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00744887 | Aug → Dec 2008 | AIDS | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT00775125 | Jun → Oct 2008 | HIV infectious disease, hepatitis C virus infection | Tibotec BVBA | Completed | No outcome recorded |
| Phase 1 | NCT00752310 | Apr → Aug 2008 | — | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT00877591 | Apr 2008 → Apr 2013 | HIV infectious disease, opiate dependence | University of California, San Francisco | Completed | No outcome recorded |
| Phase 1 | NCT00307502 | Jan 2005 → Dec 2009 | HIV infectious disease | Germans Trias i Pujol Hospital | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06139796 | Feb → Jul 2025 | HIV infectious disease | PENTA Foundation | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT01565889 | Mar 2012 → Aug 2013 | HIV infectious disease, hepatitis C virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 1/2 | NCT00260078 | Feb 2006 → Apr 2009 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 223 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT06338826 | Feb 2025 → Sep 2027 expected | HIV infectious disease | ANRS, Emerging Infectious Diseases | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03602690 | Oct 2018 → Apr 2022 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Unknown | No outcome recorded |
| Phase 2 | NCT03589040 | Sep 2018 → Jun 2019 | HIV infectious disease | Makerere University | Unknown | No outcome recorded |
| Phase 2 | NCT03589027 | Aug 2018 → Jun 2019 | HIV infectious disease | Makerere University | Unknown | No outcome recorded |
| Phase 2 | NCT02738502 | Jul 2016 → Jul 2019 | viral infectious disease | ANRS, Emerging Infectious Diseases | Completed | No outcome recorded |
| Phase 2 | NCT02384967 | Mar 2015 → Oct 2016 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | No outcome recorded |
| Phase 2 | NCT02025868 | Mar 2013 → Aug 2016 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Unknown | No outcome recorded |
| Phase 2 | NCT01138605 | Oct 2010 → Nov 2017 | HIV infectious disease | Janssen Sciences Ireland UC | Completed | No outcome recorded |
| Phase 2 | NCT01199939 | May 2010 → Oct 2012 | HIV infectious disease | Tibotec, Inc | Completed | No outcome recorded |
| Phase 2 | NCT00993148 | May 2010 → Apr 2013 | HIV infectious disease | Northwestern University | Completed | No outcome recorded |
| Phase 2 | NCT00919854 | Sep 2009 → Aug 2010 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 2 | NCT00915655 | Jul 2009 → Sep 2010 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 2 | NCT01391013 | Jun 2009 → Apr 2011 | HIV infectious disease | Janssen-Cilag S.p.A. | Completed | Missed primary |
| Phase 2 | NCT00830804 | Apr 2009 → Feb 2010 | HIV infectious disease | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | No outcome recorded |
| Phase 2 | NCT00534352 | Jan → May 2008 | HIV infectious disease | Tibotec, Inc | Completed | No outcome recorded |
| Phase 2 | NCT00460382 | May 2007 → Mar 2008 | HIV infectious disease | French National Agency for Research on AIDS and Viral Hepatitis | Completed | No outcome recorded |
| Phase 2 | NCT00513513 | Sep 2006 → Sep 2007 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00355524 | Jun 2006 → Aug 2007 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 2 | NCT02187107 | Jan → Sep 2005 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 2 | NCT00081588 | Nov 2003 → Sep 2005 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 2 | NCT00650832 | Oct 2003 → Feb 2005 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | Met primary |
| Phase 2 | NCT00071097 | Oct 2003 → Feb 2005 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | Met primary |
| Phase 2 | NCT00964327 | Aug 2001 → Oct 2003 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 2/34 trials · 1 met primary · 1 missed | ||||||
| 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 | NCT02016924 | Jan 2014 → Jun 2025 overdue | AIDS | Gilead Sciences | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT00624195 | Mar 2007 → Feb 2012 | HIV infectious disease | University of California, San Diego | Completed | Missed primary |
| Phase 326 trials · 8 met primary · 5 missed | ||||||
| Phase 3 | NCT04867083 | Jun 2021 → Jul 2023 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Unknown | Missed primary |
| Phase 3 | NCT04653194 | Sep 2020 → Jul 2023 | HIV infectious disease | Chelsea and Westminster NHS Foundation Trust | Completed | No outcome recorded |
| Phase 3 | NCT04252274 | Jan → Aug 2020 | COVID-19, pneumocystosis | Shanghai Public Health Clinical Center | Unknown | Missed primary |
| Phase 3 | NCT03988452 | Jul 2019 → Sep 2020 | HIV infectious disease | Makerere University | Unknown | Met primary |
| Phase 3 | NCT02588820 | Apr 2016 → Nov 2018 | HIV infectious disease | David Garcia Cinca | Unknown | No outcome recorded |
| Phase 3 | NCT02431247 | Jul 2015 → Mar 2017 | immunodeficiency disease | Janssen Sciences Ireland UC | Completed | Met primary |
| Phase 3 | NCT02269917 | Mar 2015 → Feb 2017 | HIV infectious disease | Janssen R&D Ireland | Completed | Met primary |
| Phase 3 | NCT01792570 | Sep 2014 → Dec 2018 | HIV infectious disease | ASST Fatebenefratelli Sacco | Completed | No outcome recorded |
| Phase 3 | NCT02155101 | May 2014 → Jun 2016 | HIV infectious disease | University of Liverpool | Completed | No outcome recorded |
| Phase 3 | NCT01605084 | Jun 2012 → Aug 2014 | HIV infectious disease | Bristol-Myers Squibb | Withdrawn | No outcome recorded |
| Phase 3 | NCT01448707 | Mar 2012 → Jun 2014 | AIDS | Janssen-Cilag International NV | Completed | Missed primary |
| Phase 3 | NCT01516970 | Nov 2011 → Aug 2013 | HIV infectious disease | Janssen-Cilag GmbH | Completed | Missed primary |
| Phase 3 | NCT01281813 | Aug 2011 → Jul 2021 | HIV infectious disease | Janssen Sciences Ireland UC | Completed | No outcome recorded |
| Phase 3 | NCT00811954 | May 2009 → Jun 2013 | HIV infectious disease | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | No outcome recorded |
| Phase 3 | NCT00849160 | May 2009 → Jun 2011 | HIV infectious disease | Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida | Completed | No outcome recorded |
| Phase 3 | NCT00855335 | Apr 2009 → Aug 2016 | HIV infectious disease, pregnancy disorder | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00537394 | Jan 2008 → May 2012 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 3 | NCT00524368 | Oct 2007 → Aug 2009 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | Met primary |
| Phase 3 | NCT00517192 | Sep 2007 → Sep 2008 | HIV infectious disease | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 3 | NCT00458302 | Jun 2007 → Feb 2009 | HIV infectious disease | Janssen-Cilag International NV | Completed | Met primary |
| Phase 3 | NCT00460746 | May 2007 → Oct 2008 | HIV infectious disease | Tibotec, Inc | Completed | No outcome recorded |
| Phase 3 | NCT00421551 | Mar 2007 → Jun 2010 | HIV infectious disease | French National Agency for Research on AIDS and Viral Hepatitis | Completed | No outcome recorded |
| Phase 3 | NCT00381303 | Nov 2006 → Nov 2008 | HIV infectious disease | Tibotec, Inc | Completed | Missed primary |
| Phase 3 | NCT00258557 | Sep 2005 → Jun 2007 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | Met primary |
| Phase 3 | NCT00115050 | Jun 2005 → Jun 2007 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 3 | NCT00110877 | Apr 2005 → Jan 2007 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | Met primary |
| Phase 438 trials · 3 met primary · 6 missed | ||||||
| Phase 4 | NCT06337032 | Aug 2024 → Mar 2034 expected | HIV infectious disease | Gilead Sciences | Recruiting | No outcome recorded |
| Phase 4 | NCT04388904 | Sep 2021 → Apr 2024 | HIV infectious disease | The Crofoot Research Center, Inc. | Completed | 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 | NCT04435587 | Jul 2020 → Jun 2021 | COVID-19 | Mahidol University | Unknown | No outcome recorded |
| Phase 4 | NCT04442737 | Jul 2020 → Aug 2023 | — | Janssen Scientific Affairs, LLC | Completed | Missed primary |
| Phase 4 | NCT03675815 | Dec 2019 → Jan 2024 | HIV infectious disease | Kirby Institute | Completed | No outcome recorded |
| 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 | NCT03017872 | Nov 2017 → Nov 2022 | HIV infectious disease | Kirby Institute | Unknown | Met primary |
| Phase 4 | NCT03447873 | Jun 2017 → Sep 2020 | HIV infectious disease | Hospitales Universitarios Virgen del Rocío | Completed | No outcome recorded |
| Phase 4 | NCT03163277 | May 2017 → Jun 2020 | HIV infectious disease, cognitive disorder | Giovanni Di Perri | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03123848 | Apr → May 2017 | — | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 4 | NCT03101644 | Mar 2017 → Jun 2019 | HIV infectious disease | Catholic University of Louvain | Completed | No outcome recorded |
| Phase 4 | NCT04064632 | Feb 2017 → Jun 2019 | HIV infectious disease | A.O. Ospedale Papa Giovanni XXIII | Unknown | Met primary |
| Phase 4 | NCT02503462 | Jul 2015 → Jan 2017 | AIDS dementia complex | University Hospital, Basel, Switzerland | Terminated | No outcome recorded |
| Phase 4 | NCT02513147 | Jun 2015 → Nov 2016 | — | Hospital Universitari Vall d'Hebron Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT02404233 | Mar 2015 → Sep 2016 | HIV infectious disease | Therapeutic Concepts | Unknown | No outcome recorded |
| Phase 4 | NCT02199613 | Oct 2014 → Feb 2017 | HIV infectious disease | University of British Columbia | Completed | No outcome recorded |
| Phase 4 | NCT02159599 | Jul 2014 → Apr 2016 | HIV infectious disease | Fundacion SEIMC-GESIDA | Completed | Met primary |
| Phase 4 | NCT01641367 | Feb 2013 → Nov 2016 | HIV infectious disease | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | No outcome recorded |
| Phase 4 | NCT01367236 | Jan 2013 → Oct 2015 | HIV infectious disease, cognitive disorder | Imperial College London | Completed | Missed primary |
| Phase 4 | NCT01736761 | Dec 2012 → Mar 2015 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 4 | NCT01702090 | Feb → Jun 2012 | — | Janssen-Cilag Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT01423812 | Jan 2012 → May 2014 | HIV infectious disease | Ruth M. Rothstein CORE Center | Completed | No outcome recorded |
| Phase 4 | NCT01367210 | Jun 2011 → Jun 2015 | HIV infectious disease | Catholic University of the Sacred Heart | Terminated | No outcome recorded |
| Phase 4 | NCT01274780 | May 2011 → May 2013 | — | Juan A. Arnaiz | Completed | Missed primary |
| Phase 4 | NCT01343225 | May 2011 → May 2014 | HIV infectious disease | East Carolina University | Unknown | No outcome recorded |
| Phase 4 | NCT01422369 | Apr → Jun 2011 | — | Kowa Research Institute, Inc. | Completed | Mixed |
| Phase 4 | NCT01346982 | Mar → Jul 2011 | HIV infectious disease | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 4 | NCT01928407 | Feb → Mar 2011 | HIV infectious disease, immunodeficiency-related disorder | Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba | Completed | Missed primary |
| Phase 4 | NCT01013987 | Feb 2010 → ? | AIDS | Fundación Huésped | Unknown | No outcome recorded |
| Phase 4 | NCT00994344 | Oct 2009 → Oct 2012 | HIV infectious disease | Germans Trias i Pujol Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00855413 | Mar 2009 → Nov 2013 | HIV infectious disease | University of North Carolina, Chapel Hill | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00757783 | Oct 2008 → Aug 2009 | HIV infectious disease | Tibotec, Inc | Completed | No outcome recorded |
| Phase 4 | NCT00756730 | Sep 2008 → Jun 2011 | HIV infectious disease | Community Research Initiative of New England | Completed | No outcome recorded |
| Phase 4 | NCT01810887 | May → Jul 2008 | — | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 4 | NCT00630734 | Feb 2008 → Oct 2009 | HIV infectious disease, hyperlipidemia | University of Colorado, Denver | Completed | Missed primary |
| Phase 4 | NCT00531557 | Sep 2007 → Nov 2008 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase not applicable4 trials · 1 missed | ||||||
| — | NCT03394196 | Jul 2018 → May 2020 | — | University of Washington | Terminated | No outcome recorded Stop: Business |
| — | NCT01294761 | Feb 2011 → Feb 2012 | HIV infectious disease | National Center for Global Health and Medicine, Japan | Completed | Missed primary |
| — | NCT02097381 | Apr 2010 → Mar 2014 | HIV infectious disease | University of Roma La Sapienza | Unknown | No outcome recorded |
| — | NCT00525733 | Oct 2007 → Dec 2013 | HIV infectious disease | Rockefeller University | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT00245739 | — | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Approved for marketing | No outcome recorded |
| Comparator or background therapy62 trials | ||||||
| Phase 1 | NCT02556268 Background | Feb → Dec 2016 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT01047995 Comparator | Jun → Dec 2009 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 1 | NCT00765271 Comparator | May → Oct 2008 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 1 | NCT02251795 Comparator | Aug 2007 → Jun 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1/2 | NCT02475915 Background | Jan → Nov 2015 | — | SEARCH Research Foundation | Completed | No outcome recorded |
| Phase 1/2 | NCT00885495 Comparator | Jan 2009 → Apr 2010 | HIV infectious disease | University of Cincinnati | Completed | No outcome recorded |
| Phase 2 | NCT06799650 Background | Jan → Nov 2025 overdue | post-viral disorder | Federal University of São Paulo | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06676410 Comparator | Jul 2023 → Dec 2024 overdue | HIV infectious disease | Code Pharma | 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 | NCT02336074 Background | Nov 2015 → Nov 2017 | HIV infectious disease | Imperial College London | Completed | Missed primary |
| Phase 2 | NCT02116660 Comparator | Sep 2014 → Jul 2017 | HIV infectious disease | Merck Sharp & Dohme LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01565850 Comparator | Apr 2012 → Jan 2013 | AIDS | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01400412 Background | Jan 2012 → Jun 2014 | HIV infectious disease | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | Met primary |
| Phase 2 | NCT01254656 Background | Feb 2011 → Apr 2013 | — | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT00827112 Background | Mar 2009 → Jul 2010 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 2 | NCT00665847 Background | Nov 2008 → May 2011 | — | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 2/3 | NCT04475120 Comparator | Apr → Jul 2020 | COVID-19 | University of Rome Tor Vergata | Completed | No outcome recorded |
| Phase 2/3 | NCT02285114 Background | Jan 2015 → Nov 2019 | — | Gilead Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT01923311 Background | Aug 2013 → Nov 2017 | AIDS | Gilead Sciences | Terminated | No outcome recorded |
| Phase 3 | NCT06747507 Comparator | Sep 2025 → Dec 2026 expected | HIV infectious disease | University of Nairobi | 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 | NCT03631732 Comparator | Aug 2018 → Aug 2019 | HIV infectious disease | 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 | NCT03227861 Background | Jul 2017 → Jan 2019 | — | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02987530 Comparator | Apr 2017 → Jul 2019 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | Missed primary |
| Phase 3 | NCT02671383 Comparator | Jun 2016 → May 2018 | HIV infectious disease | Willem Daniel Francois Venter | Completed | No outcome recorded |
| Phase 3 | NCT02616783 Comparator | Dec 2015 → Feb 2018 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02603107 Background | Nov 2015 → May 2017 | 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 | NCT02469246 Background | Jun 2015 → Dec 2017 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT02397096 Background | Jun 2015 → Feb 2018 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02275780 Comparator | Dec 2014 → Sep 2016 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02302547 Comparator | Dec 2014 → Aug 2017 | HIV infectious disease | University Hospital, Tours | Completed | No outcome recorded |
| Phase 3 | NCT02247687 Comparator | Dec 2014 → Sep 2015 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02157311 Background | Jul 2014 → Jan 2016 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | No outcome recorded |
| Phase 3 | NCT02121795 Background | May 2014 → Aug 2015 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT01905059 Comparator | Feb 2014 → Apr 2016 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | No outcome recorded |
| Phase 3 | NCT01900106 Comparator | Nov 2013 → Dec 2017 | HIV infectious disease | University of Modena and Reggio Emilia | Completed | No outcome recorded |
| Phase 3 | NCT01480713 Background | May 2012 → May 2014 | HIV infectious disease | IrsiCaixa | Completed | No outcome recorded |
| Phase 3 | NCT01475838 Comparator | Nov 2011 → Nov 2013 | AIDS | Gilead Sciences | Completed | Met primary |
| Phase 3 | NCT01449929 Comparator | Oct 2011 → Apr 2013 | HIV infectious disease | ViiV Healthcare | Completed | Met primary |
| Phase 3 | NCT01345630 Background | Sep 2011 → Aug 2013 | — | ViiV Healthcare | Terminated | Missed primary |
| Phase 3 | NCT01363011 Background | May 2011 → Jan 2013 | AIDS | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01252940 Background | Nov 2010 → Jan 2012 | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 3 | NCT01066962 Background | Aug 2010 → Oct 2013 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | Met primary |
| Phase 3 | NCT01033760 Background | Apr 2010 → Jul 2013 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | Missed primary |
| Phase 3 | NCT00928187 Comparator | Nov 2009 → Sep 2013 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | No outcome recorded |
| Phase 3 | NCT00708162 Background | Jul 2008 → Dec 2010 | HIV infectious disease | Gilead Sciences | Completed | Met primary |
| Phase 4 | NCT07678268 Comparator | Jul 2025 → Jul 2026 overdue | HIV infectious disease | Mexican Social Security Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT03842488 Comparator | Apr 2019 → Mar 2021 | HIV infectious disease | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud | Unknown | No outcome recorded |
| Phase 4 | NCT02770508 Background | Nov 2015 → Jul 2017 | HIV infectious disease | Fundación Huésped | Completed | Met primary |
| Phase 4 | NCT02470650 Comparator | Jun 2015 → Jul 2017 | poisoning | Juan A. Arnaiz | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02337322 Comparator | Mar 2015 → Dec 2019 | HIV infectious disease | Juan A. Arnaiz | Unknown | No outcome recorded |
| Phase 4 | NCT01869634 Comparator | Jun 2013 → Dec 2016 | HIV infectious disease | University of California, Davis | Completed | No outcome recorded |
| Phase 4 | NCT01637259 Comparator | Jun 2012 → Dec 2015 | HIV infectious disease, proteinuria | Kirby Institute | Completed | No outcome recorded |
| Phase 4 | NCT01258439 Comparator | Nov 2010 → Jul 2014 | HIV infectious disease, cardiovascular disorder | St Vincent's Hospital, Sydney | Completed | No outcome recorded |
| Phase 4 | NCT01118871 Comparator | May 2010 → May 2013 | HIV infectious disease | Imperial College London | Terminated | No outcome recorded |
| Phase 4 | NCT00782301 Comparator | Mar 2009 → Feb 2010 | HIV infectious disease, chronic hepatitis C virus infection, hepatitis B virus infection | ViiV Healthcare | Withdrawn | No outcome recorded |
| Phase 4 | NCT00677300 Background | Jan 2009 → Oct 2012 | HIV infectious disease | Dallas VA Medical Center | Completed | Missed primary |
| Phase 4 | NCT00765154 Comparator | Oct 2008 → Jul 2010 | HIV infectious disease | St Stephens Aids Trust | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00611039 Comparator | Feb 2008 → Jul 2009 | HIV infectious disease | Germans Trias i Pujol Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00543101 Comparator | Oct 2007 → Feb 2010 | HIV infectious disease | Community Research Initiative of New England | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2024-06-04 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson Submits Supplemental New Drug Application to U.S. FDA Seeking Expanded Pediatric Indication for HIV-1 Therapy PREZCOBIX® jnj.com ↗
Johnson & Johnson today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of PREZCOBIX®(darunavir/cobicistat) to include the treatment of HIV-1 infection in younger children at least 6 years of age weighing at least 25 kg. |
| 2023-12-15 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Darunavir Tablets 600 mg and 800 mg, and tentative approval for 75 mg and 150 mg tablets zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Darunavir Tablets 600 mg and 800 mg, and tentative approval for 75 mg and 150 mg tablets (USRLD: Prezista® Tablets, 75 mg, 150 mg, 600 mg, and 800 mg). |
| 2022-10-04 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Darunavir Tablets lupin.com ↗ |
| 2020-03-16 | Janssen Research & Development, LLC | Results Lack of evidence to support use of darunavir-based treatments for SARS-CoV-2 jnj.com ↗
DRV showed no activity against SARS-CoV-2 at clinically relevant concentrations (EC50 >100 μM). |
| 2018-07-24 | Merck Sharp & Dohme LLC | Results Merck Announces Week 96 Data from Pivotal Phase 3 DRIVE-FORWARD Study of Its Investigational HIV Therapy Doravirine merck.com ↗
compared to 66.0 percent (248/376) of the group treated with once-daily ritonavir-boosted darunavir (DRV+r) |
| 2017-10-25 | Janssen Research & Development, LLC | Results Investigational Darunavir-Based Single-Tablet Regimen Shows Positive Results in Previously Untreated HIV Patients in Pivotal Phase 3 AMBER Clinical Trial jnj.com ↗ |
| 2017-10-04 | Gilead Sciences | Results Gilead Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide From Boosted Protease Inhibitor-Based Regimens gilead.com ↗
In the ongoing study, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing bPIs and demonstrated no treatment-emergent resistance at 48 weeks. |
| 2017-02-14 | Merck Sharp & Dohme LLC | Results Merck’s Doravirine, an Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) for the Treatment of HIV-1 Infection, Met Primary Efficacy Endpoint in Pivotal Phase 3 Trial merck.com ↗
In addition, a secondary endpoint showed that the DOR-treated group had statistically significant lower levels of fasting low density lipoprotein cholesterol (LDL-C), versus the DRV+r group. |
| 2016-09-12 | Janssen Research & Development, LLC | Regulatory Janssen Submits Marketing Authorisation Application for Darunavir-Based Single Tablet Regimen for Treatment of HIV-1 to European Medicines Agency jnj.com ↗ |
| 2015-01-29 | Janssen Research & Development, LLC | Regulatory PREZCOBIX™ (darunavir/cobicistat) Approved in the U.S. for the Treatment of Adults Living With HIV-1 jnj.com ↗ |
| 2014-11-25 | Janssen Research & Development, LLC | Regulatory European Commission Approves REZOLSTA®▼, A New Once-Daily, Fixed-Dose HIV Therapy Combining Darunavir And Cobicistat jnj.com ↗
Beerse, Belgium, 25 November 2014 - Janssen-Cilag International NV (Janssen) today announced that the European Commission (EC) has approved the use of REZOLSTA® (darunavir/cobicistat) in combination with other antiretroviral (ARV) medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older. |
| 2014-09-29 | Janssen Research & Development, LLC | Regulatory CHMP Announces Positive Opinion For REZOLSTA™, A New Once-Daily, Fixed-Dose HIV Therapy Combining Darunavir And Cobicistat jnj.com ↗
CHMP Announces Positive Opinion For REZOLSTA™, A New Once-Daily, Fixed-Dose HIV Therapy Combining Darunavir And Cobicistat |
| 2014-07-22 | Pfizer | Results ViiV Healthcare presents phase III data comparing once-daily maraviroc in combination with darunavir/ritonavir with emtricitabine/tenofovir plus darunavir/ritonavir in treatment-naïve adults with HIV-1 pfizer.com ↗
The proportion of study participants who were virologically suppressed (HIV-1 RNA <50 copies/mL) at week 48 was 77.3% for MVC+DRV/r compared to 86.8% for FTC /TDF +DRV/r (95% confidence interval -15.0% to -4.4%). |
| 2014-07-22 | GlaxoSmithKline | Results ViiV Healthcare presents phase III data gsk.com ↗
The proportion of study participants who were virologically suppressed (HIV-1 RNA <50 copies/mL) at week 48 was 77.3% for MVC+DRV/r compared to 86.8% for FTC /TDF +DRV/r (95% confidence interval -15.0% to -4.4%). |
| 2014-04-01 | Janssen Research & Development, LLC | Regulatory Janssen Submits New Drug Application to U.S. FDA for a Fixed-Dose Combination Tablet of HIV-1 Medicine Darunavir with Cobicistat as Part of Combination HIV Therapy jnj.com ↗
Janssen Submits New Drug Application to U.S. FDA for a Fixed -Dose Combination Tablet of HIV-1 Medicine Darunavir with Cobicistat as Part of Combination HIV Therapy |
| 2014-03-05 | Merck Sharp & Dohme LLC | Results New 96-Week ACTG Study Results Presented at CROI 2014; First Large Study Comparing ISENTRESS® (raltegravir) Regimen to Two Protease Inhibitor Regimens in Previously Untreated Adults with HIV-1 merck.com ↗
On the other co-primary endpoint of failure due to tolerability, the ISENTRESS and darunavir/r regimens were superior to the atazanavir/r regimen. |
| 2013-10-15 | Janssen Research & Development, LLC | Regulatory Janssen Submits Marketing Authorisation Application to European Medicines Agency for a Fixed-Dose Combination Tablet of HIV-1 Medicine Darunavir with Cobicistat jnj.com ↗ |
| 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 ↗
This open-label study, for the first time, compared once-daily regimens containing 50mg dolutegravir with once-daily regimens containing a protease inhibitor (PI) (800mg darunavir boosted with 100mg ritonavir) in treatment-naïve adults with HIV-1. |
| 2012-07-22 | Eli Lilly and Company | Results Pharmacokinetic Study Results Released Evaluating Interactions Between LIVALO® (pitavastatin) and Protease Inhibitor Combination (darunavir/ritonavir) in Healthy Volunteers lilly.com ↗
The study, presented at the 19th International AIDS Conference in Washington, DC, found that when co-administered, the blood levels for LIVALO and each of the PIs were not significantly affected. |
| 2012-03-06 | Merck Sharp & Dohme LLC | Results Results from Investigational Studies with VICTRELIS™ (boceprevir) Presented at the Conference on Retroviruses and Opportunistic Infections to Understand Potential Use in Patients Coinfected with Chronic Hepatitis C and HIV-1 merck.com ↗
In this study, concomitant administration of VICTRELIS with ritonavir (Norvir ® ) in combination with atazanavir (Reyataz ® ) or darunavir (Prezista ® ), or with lopinavir/ritonavir (Kaletra ® ) resulted in reduced exposures of the HIV medicines and VICTRELIS. |
| 2012-02-08 | Merck Sharp & Dohme LLC | Results Merck Informs U.S. Physicians of Results of Drug Interaction Study of Co-Administration of VICTRELIS™ with Ritonavir-Boosted HIV Protease Inhibitors merck.com ↗
In this study, concomitant administration of VICTRELIS with ritonavir (Norvir®) in combination with atazanavir (Reyataz®) or darunavir (Prezista®),or with lopinavir/ritonavir (Kaletra®) resulted in reduced exposures of the HIV medicines and VICTRELIS. |
All press releases naming this drug 27 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 208 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Darunavir | “Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine,...” NCT00624195 ↗191“Antiretroviral therapy, administered orally may include regimens such as: bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir...” NCT05729568 ↗ “The purpose of this study is to compare the drug levels of darunavir obtained after administration of a single administration of the 800 mg tablet (new formulation) to that...” NCT01052883 ↗ “Eligible, consenting subjects will start open-label darunavir 800mg plus the co-formulated tenofovir DF/FTC/cobicistat/elvitegravir (Stribild) tablet once daily with food,...” NCT02199613 ↗ “Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised...” PMID 17617272 ↗ Jul 2007 “Baseline regimen of antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) administered according to the...” NCT02397096 ↗ “Any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir ; consistent with the most recent prescribing information documents” NCT02556268 ↗ “Tenofovir+Emtricitabine+Third agent (Including a ritonavir-boosted protease inhibitor : saquinavir or indinavir or fosamprenavir or tipranavir or darunavir or atazanavir or lopinavir” NCT02302547 ↗ “(Fosamprenavir, atazanavir, lopinavir or darunavir) boosted with 100 mg of ritonavir, or atazanavir (400 mg / d) not boosted with ritonavir,if the 2 NRTIs are abacavir + Lamivudine” NCT02513147 ↗ “Once-daily single-tablet regimen containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg.” NCT02269917 ↗ “a fixed-dose combination of tenofovir alafenamide fumarate (TAF) 10 mg plus emtricitabine (FTC) 200 mg, darunavir 800 mg, and cobicistat 150 mg once daily (group A)” PMID 37752816 ↗ Sep 2023 |
| Known as | DAR | “Darunavir (DAR) 400 mg tablets” NCT02116660 ↗ |
| Known as | darunavir = TMC114 | “darunavir = TMC114” NCT01047995 ↗ |
| Known as | darunavir/r | “Background regimen may consist of the following ritonavir (RTV)-boosted PIs (PI/r): lopinavir/r (Kaletra), atazanavir/r, darunavir/r, tipranavir/r, or fosamprenavir/r.” NCT01923311 ↗4“protease inhibitors : lopinavir/r, darunavir/r ou atazanavir/r” NCT03256422 ↗ “darunavir/r,” NCT02157311 ↗ |
| Known as | DRV | “The objectives of this trial are in Part 1 to compare the rate and extent of absorption of a single oral dose of 600 mg darunavir (DRV) administered as the suspension...” NCT00752310 ↗44“This is a Phase I, partially randomized, open-label, single-center, two-way, two-period cross-over study to investigate the pharmacokinetic interaction between etravirine (ETR)...” NCT01876966 ↗ “The objectives are to determine the effect of different ritonavir doses on darunavir (DRV) oral exposure following once-daily oral dosing of DRV/rtv for 7 days, in order to...” NCT00744887 ↗ “This study is a Phase II single arm, open-label, multicenter, (all people involved know the identity of the intervention) study of 50 HIV-1 infected adult patients, all of whom...” NCT01199939 ↗ “The purpose of the study is to evaluate the single-dose pharmacokinetics (PK) and pivotal bioequivalence of 3 compounds Darunavir (DRV), emtricitabine (FTC), and tenofovir...” NCT04661397 ↗ “Participants will receive either darunavir (DRV)/ cobicistat (COBI)/emtricitabine (FTC) /tenofovir alafenamide (TAF) fixed dose combination (D/C/F/TAF FDC) or DRV/COBI FDC...” NCT02431247 ↗ “Once-daily single-tablet regimen containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg.” NCT02269917 ↗ “In treatment A you will receive a single dose of darunavir (DRV) two 400 mg commercial formulation in the morning of day 3 after a standard breakfast.” NCT01052883 ↗ “Basing in studies which have related the darunavir (DRV) virtual inhibitory quotient (vIQ) with the virological response” NCT00611039 ↗ “Participants will receive oral tablet of fixed dose combination (FDC) containing darunavir (DRV)/ cobicistat (COBI).” NCT04208061 ↗ “800 mg Darunavir (DRV) on day 7 combined with TMC55844 that has been given for 7 days at 200 mg once daily dosis.” NCT00838760 ↗ |
| Known as | DRV/r | “Participants were randomized to lamivudine (3TC)/abacavir (ABC)/DTG (DTG arm) and 3TC/ABC/DRV + ritonavir (DRV/r arm).” PMID 41083105 ↗ Oct 20252“raltegravir (RAL) plus ritonavir-boosted Darunavir (DRV/r)” PMID 23951362 ↗ Aug 2013 “Darunavir (DRV/r)” NCT00543101 ↗ |
| Known as | pRezista | “The Intelence aNd pRezista Once A Day Study (INROADS): a multicentre, single-arm, open-label study of etravirine and darunavir/ritonavir as dual therapy in HIV-1-infected early...” PMID 25585528 ↗ Jan 20159“Switching From Lopinavir/Ritonavir Plus Tenofovir and Emtricitabine (or Lamivudine) to Darunavir (Prezista) and Raltegravir to Evaluate Renal Function” NCT01294761 ↗ “PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg twice a day” NCT00381303 ↗ “Darunavir/Ritonavir (Prezista) 800 mg/100 mg” NCT01422369 ↗ “darunavir (Prezista®): 800 mg QD.” NCT01033760 ↗ “darunavir (DRV; Prezista®) + COBI” NCT02616783 ↗ “darunavir (DRV; Prezista®) + RTV” NCT02605954 ↗ “darunavir (PREZISTA™)/ Ritonavir” NCT00534352 ↗ “TMC114; darunavir; Prezista” NCT00650832 ↗ “PREZISTA (darunavir) 600 mg” NCT00460746 ↗ |
| Known as | TMC114 | “Safety and efficacy of darunavir (TMC114) with low-dose ritonavir in treatment-experienced patients: 24-week results of POWER 3.” PMID 17621237 ↗ Sep 200712“TMC114 (darunavir) two 300 mg or one 600 mg tablet twice daily up to 12 weeks postpartum in Group 1.” NCT00855335 ↗ “darunavir (DRV, TMC114)” NCT00458302 ↗ |
| Known as | TMC41629 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00854204 ↗ |
| Action | Inhibit | “an investigational protease inhibitor (PI) called TMC114” NCT00071097 ↗ |
| Modality | Small molecule | “Darunavir is a nonpeptidic protease inhibitor with a high genetic barrier to resistance that evolved from a prototype compound synthesized using structure-based design strategies.” NCT01423812 ↗ |
| Route | Oral | “taken orally” NCT00115050 ↗ |