Darunavir

also known as DRV · TMC114 · PREZISTA · darunavir/r · DRV/r · DAR · darunavir = TMC114 · TMC41629

Developed for: HIV infectious disease · AIDS · cognitive disorder · COVID-19 · amyotrophic lateral sclerosis · immunodeficiency disease · immunodeficiency-related disorder · viral infectious disease
Investigated by: Tibotec Pharmaceuticals, Ireland · Gilead Sciences · National Institute of Allergy and Infectious Diseases (NIAID) · Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA · ViiV Healthcare · ANRS, Emerging Infectious Diseases
+121 more
· Janssen Scientific Affairs, LLC · Tibotec, Inc · Janssen Research & Development, LLC · Merck Sharp & Dohme LLC · Pfizer · St Stephens Aids Trust · Tibotec Pharmaceutical Limited · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Bristol-Myers Squibb · Fight AIDS and Infectious Diseases Foundation · French National Institute of Health and Medical Research · Janssen Pharmaceutica · Janssen Sciences Ireland UC · GlaxoSmithKline · Imperial College London · Kirby Institute · Makerere University · National Institutes of Health Clinical Center (CC) · University of Liverpool · Boehringer Ingelheim · French National Agency for Research on AIDS and Viral Hepatitis · Germans Trias i Pujol Hospital · IrsiCaixa · Janssen Pharmaceutica N.V., Belgium · Janssen Pharmaceutical K.K. · Janssen Pharmaceuticals · Janssen-Cilag International NV · Janssen-Cilag Ltd. · PENTA Foundation · UNITAID · University of Colorado, Denver · University of Nebraska · University of North Carolina, Chapel Hill · University of Pittsburgh · A.O. Ospedale Papa Giovanni XXIII · ADRIANO LAZZARIN, MD · AMS-PHPT Research Collaboration · ASST Fatebenefratelli Sacco · Aaron Diamond AIDS Research Center · AbbVie · Baylor College of Medicine · Catholic University of Louvain · Catholic University of the Sacred Heart · Centers for Disease Control and Prevention · Centre Hospitalier National d'Enfants Albert Royer · Centre Mère et Enfant de la Fondation Chantal Biya · Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida · Centre de Sante de Ziguinchor, Casamance, Senegal · Chantal Biya International Reference Centre for Research on Prevention and Management of HIV/AIDS · Chelsea and Westminster NHS Foundation Trust · Clinique des Maladies Infectieuses, CHNU de Fann, Dakar, Senegal · Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Community Research Initiative of New England · David Garcia Cinca · Desmond Tutu HIV Centre · Dimagi Inc. · East Carolina University · Elisa Colella, M.D. · Emory University · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Frederick National Laboratory for Cancer Research · Fundacion Clinic per a la Recerca Biomédica · Fundacion SEIMC-GESIDA · Fundación Huésped · Giovanni Di Perri · Hoffmann-La Roche · Hospital Universitari Vall d'Hebron Research Institute · Hospitales Universitarios Virgen del Rocío · Infectious Diseases Institute, Uganda · Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba · Instituto de Salud Carlos III · Italian National Institute of Health · Janssen R&D Ireland · Janssen, LP · all 127 on the full record

Regulatory milestones approvals, filings & regulatory actions · 12 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
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

today

US approved 2006

EU approved 2007

200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 142 trials
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	No outcome recorded
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	NCT01323257	Mar → Aug 2011	chronic hepatitis C virus infection	Tibotec Pharmaceuticals, Ireland	Completed	No outcome recorded
Phase 1	NCT01876966	Mar → Jul 2011	HIV infectious disease	Janssen Pharmaceutica N.V., Belgium	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
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	NCT00993148	May 2010 → Apr 2013	HIV infectious disease	Northwestern University	Completed	No outcome recorded
Phase 2	NCT01199939	May 2010 → Oct 2012	HIV infectious disease	Tibotec, Inc	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	No outcome recorded
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
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	No outcome recorded
Phase 2	NCT00071097	Oct 2003 → Feb 2005	HIV infectious disease	Tibotec Pharmaceuticals, Ireland	Completed	No outcome recorded
Phase 2	NCT00964327	Aug 2001 → Oct 2003	HIV infectious disease	Tibotec Pharmaceuticals, Ireland	Completed	No outcome recorded

Phase 2/34 trials
Phase 2/3	NCT02383108	Jun 2016 → Aug 2020	HIV infectious disease	PENTA Foundation	Completed	No outcome recorded
Phase 2/3	NCT02499978	May → Jun 2016	AIDS	Stanford University	Withdrawn	No outcome recorded
Phase 2/3	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	No outcome recorded
Phase 326 trials
Phase 3	NCT04867083	Jun 2021 → Jul 2023	HIV infectious disease	ANRS, Emerging Infectious Diseases	Unknown	No outcome recorded
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	No outcome recorded
Phase 3	NCT03988452	Jul 2019 → Sep 2020	HIV infectious disease	Makerere University	Unknown	No outcome recorded
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	No outcome recorded
Phase 3	NCT02269917	Mar 2015 → Feb 2017	HIV infectious disease	Janssen R&D Ireland	Completed	No outcome recorded
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	No outcome recorded
Phase 3	NCT01516970	Nov 2011 → Aug 2013	HIV infectious disease	Janssen-Cilag GmbH	Completed	No outcome recorded
Phase 3	NCT01281813	Aug 2011 → Jul 2021	HIV infectious disease	Janssen Sciences Ireland UC	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	NCT00811954	May 2009 → Jun 2013	HIV infectious disease	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	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	No outcome recorded
Phase 3	NCT00524368	Oct 2007 → Aug 2009	HIV infectious disease	Tibotec Pharmaceuticals, Ireland	Completed	No outcome recorded
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	No outcome recorded
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	No outcome recorded
Phase 3	NCT00258557	Sep 2005 → Jun 2007	HIV infectious disease	Tibotec Pharmaceuticals, Ireland	Completed	No outcome recorded
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	No outcome recorded

Phase 438 trials
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	No outcome recorded
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	No outcome recorded
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	No outcome recorded
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
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	No outcome recorded
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	No outcome recorded
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	No outcome recorded
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	NCT01343225	May 2011 → May 2014	HIV infectious disease	East Carolina University	Unknown	No outcome recorded
Phase 4	NCT01274780	May 2011 → May 2013	—	Juan A. Arnaiz	Completed	No outcome recorded
Phase 4	NCT01422369	Apr → Jun 2011	—	Kowa Research Institute, Inc.	Completed	No outcome recorded
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	No outcome recorded
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
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	No outcome recorded
Phase 4	NCT00531557	Sep 2007 → Nov 2008	HIV infectious disease	St Stephens Aids Trust	Completed	No outcome recorded

Phase not applicable4 trials
—	NCT03394196	Jul 2018 → May 2020	—	University of Washington	Terminated	No outcome recorded
—	NCT01294761	Feb 2011 → Feb 2012	HIV infectious disease	National Center for Global Health and Medicine, Japan	Completed	No outcome recorded
—	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

Also used as a comparator or background therapy in 62 trials

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 14 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 1/22 trials
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 210 trials
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	No outcome recorded
Phase 2	NCT02116660 Comparator	Sep 2014 → Jul 2017	HIV infectious disease	Merck Sharp & Dohme LLC	Terminated	No outcome recorded
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	No outcome recorded
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 2/33 trials
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 329 trials
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	No outcome recorded
Phase 3	NCT03631732 Comparator	Aug 2018 → Aug 2019	HIV infectious disease	Gilead Sciences	Completed	No outcome recorded
Phase 3	NCT03256422 Background	Sep 2017 → Aug 2019	HIV infectious disease	ANRS, Emerging Infectious Diseases	Completed	No outcome recorded
Phase 3	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	No outcome recorded
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	No outcome recorded
Phase 3	NCT02603107 Background	Nov 2015 → May 2017	HIV infectious disease	Gilead Sciences	Completed	No outcome recorded
Phase 3	NCT02605954 Comparator	Nov 2015 → Jun 2017	HIV infectious disease	Gilead Sciences	Completed	No outcome recorded
Phase 3	NCT02469246 Background	Jun 2015 → Dec 2017	HIV infectious disease	Gilead Sciences	Completed	No outcome recorded
Phase 3	NCT02397096 Background	Jun 2015 → Feb 2018	HIV infectious disease	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 3	NCT02275780 Comparator	Dec 2014 → Sep 2016	—	Merck Sharp & Dohme LLC	Completed	No outcome recorded
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
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	No outcome recorded
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	No outcome recorded
Phase 3	NCT01449929 Comparator	Oct 2011 → Apr 2013	HIV infectious disease	ViiV Healthcare	Completed	No outcome recorded
Phase 3	NCT01345630 Background	Sep 2011 → Aug 2013	—	ViiV Healthcare	Terminated	No outcome recorded
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	No outcome recorded
Phase 3	NCT01033760 Background	Apr 2010 → Jul 2013	HIV infectious disease	ANRS, Emerging Infectious Diseases	Completed	No outcome recorded
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	No outcome recorded

Phase 414 trials
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	No outcome recorded
Phase 4	NCT02470650 Comparator	Jun 2015 → Jul 2017	poisoning	Juan A. Arnaiz	Withdrawn	No outcome recorded
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	No outcome recorded
Phase 4	NCT00765154 Comparator	Oct 2008 → Jul 2010	HIV infectious disease	St Stephens Aids Trust	Terminated	No outcome recorded
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

Press releases naming this drug 3 releases

Date	Issuer	Release
2014-07-22	Pfizer	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 ↗
2011-11-15	Gilead Sciences	Gilead Sciences Finalizes Agreement with Tibotec Pharmaceuticals to Develop and Commercialize a Single-Tablet Regimen of Prezista(R) with Emtriva(R), GS 7340 and Cobicistat gilead.com ↗
2011-06-28	Gilead Sciences	Gilead Sciences Announces Agreement With Tibotec Pharmaceuticals to Develop and Commercialize a New Fixed-Dose Combination of Cobicistat and Prezista(R) gilead.com ↗

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 ↗ “Tenofovir+Emtricitabine+Third agent (Including a ritonavir-boosted protease inhibitor : saquinavir or indinavir or fosamprenavir or tipranavir or darunavir or atazanavir or lopinavir” NCT02302547 ↗ “Any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir ; consistent with the most recent prescribing information documents” NCT02556268 ↗ “(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 “Darunavir - prevents the formation of mature infective viral particles, indicated for the treatment of the human immunodeficiency virus (HIV), which causes AIDS.” NCT06676410 ↗ “Likely consisting of an Nucleoside reverse-transcriptase inhibitor (NRTI) backbone i.e. Truvada plus a ritonavir-boosted protease inhibitor (PI) e.g. Darunavir” NCT02336074 ↗ “Protease inhibitors (PIs) included amprenavir, atazanavir, darunavir, fosamprenavir, Kaletra (lopinavir/ritonavir, coformulated), ritonavir, and saquinavir.” NCT01252940 ↗ “Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV” NCT02016924 ↗ “Lersivirine 750 mg tablets PO taken once daily + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI” NCT01254656 ↗ “A FDC tablet containing darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir alafenamide 10 mg will be administered once daily.” NCT04442737 ↗ “Darunavir 800 milligram (mg)/ Cobicistat 150 mg/ Emtricitabine 200 mg/ Tenofovir Alafenamide 10 mg (D/C/F/TAF) fixed-dose combination (FDC)” NCT03227861 ↗ “darunavir and ritonavir concentrations in plasma will be determined by high performance liquid chromatography using a validated method.” NCT01346982 ↗ “Combination single tablet anti-retroviral therapy: darunavir 800mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg” NCT04653194 ↗ “Safety and efficacy of darunavir (TMC114) with low-dose ritonavir in treatment-experienced patients: 24-week results of POWER 3.” PMID 17621237 ↗ Sep 2007 “Once-daily darunavir/ritonavir vs. lopinavir/ritonavir in treatment-naive, HIV-1-infected patients: 96-week analysis.” PMID 19487905 ↗ Aug 2009 “Participants will receive oral tablet of fixed dose combination (FDC) containing darunavir (DRV)/ cobicistat (COBI).” NCT04208061 ↗ “allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)” NCT01475838 ↗ “Darunavir (DRV) is an inhibitor of the dimerization and of the catalytic activity of the HIV-1 protease.” NCT05197075 ↗ “TMC114 (Darunavir) With a Low Dose of Ritonavir as Monotherapy (no Other Anti-HIV Drugs Will be Given)” NCT00513513 ↗ “The ritonavir-boosted PIs include either ATV, darunavir, fosamprenavir, LPV (Kaletra®), or tipranavir” NCT00708162 ↗ “Prezista® (darunavir)/ Norvir® (ritonavir) (switch for a drug with a higher genetic barrier)” NCT02247687 ↗ “darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)” NCT01565850 ↗ “once daily integrase inhibitor plus boosted darunavir is non-inferior to standard of care” PMID 37304494 ↗ Jun 2023 “It is a combination of two anti-HIV medicines called darunavir (DRV) and ritonavir (RTV).” NCT06139796 ↗ “Either Once Daily Atazanavir/Ritonavir (ATV/r) or Once Daily Darunavir/Ritonavir (DRV/r)” NCT00756730 ↗ “allowed boosted 3rd ARV agents: lopinavir (LPV), atazanavir (ATV), darunavir (DRV)” NCT02285114 ↗ “Darunavir/rit 800/100 mg every 24 hours + Raltegravir 400 mg every 12 hours” NCT01480713 ↗ “Darunavir (DRV) 800 mg (2 × 400 mg tablets) administered orally once daily” NCT01565889 ↗ “Bioequivalence of Darunavir 600 mg in the Presence of Cobicistat 90 mg” NCT05378906 ↗ “alternatively darunavir 800 mg 1 cp/day+ritonavir 100 mg 1 cp/day” NCT04475120 ↗ “ritonavir (RTV)-boosted atazanavir (ATV) or darunavir (DRV)” PMID 25397568 ↗ Nov 2014 “800, 1600, 2400 or 3600 mg TMC114 (Darunavir) for 13 Days” NCT00964327 ↗ “rilpivirine 25mg plus darunavir 800mg/ritonavir 100mg QD” NCT01792570 ↗ “darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD” NCT00827112 ↗ “Darunavir/ritonavir (400/100mg) q 12 hours for 5 days” NCT04435587 ↗ “3. Darunavir/r 800mg/100mg / Lamivudine 300mg per day” NCT04867083 ↗ “darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC” NCT02469246 ↗ “darunavir 800 mg/cobicistat 150 mg once daily” NCT03094507 ↗ “boosted atazanavir (ATV) or darunavir (DRV)” NCT02603107 ↗ “TMC114, is also known as Darunavir.” NCT00854204 ↗ “ritonavir-boosted darunavir (DRV/r)” NCT02121795 ↗ “darunavir 800mg + cobicistat 150mg” NCT02589158 ↗ “PI/r = atazanavir/r ou darunavir/r” NCT06338826 ↗ “darunavir (DRV; Prezista®) + COBI” NCT02616783 ↗ “darunavir (DRV; Prezista®) + RTV” NCT02605954 ↗ “boosted darunavir (DRV)+TXF/FTC” NCT06630299 ↗ “Darunavir 800mg+Ritonavir 100mg” NCT06799650 ↗ “4. Darunavir 800 mg once a day” NCT02588820 ↗ “darunavir 600 mg. p.o. b.i.d.” NCT00782301 ↗ “TMC114; darunavir; Prezista” NCT00650832 ↗ “boosted darunavir (DRV)” NCT06337032 ↗ “darunavir 800 mg daily” NCT01367236 ↗ “darunavir [DRV]” NCT00665847 ↗ “darunavir (DRV)” NCT03631732 ↗ “darunavir” NCT01637259 ↗ NCT02277600 ↗ NCT06747507 ↗ NCT01900106 ↗ NCT02404233 ↗ NCT01391013 ↗ NCT03589027 ↗ NCT02499978 ↗ NCT04661397 ↗ NCT02470650 ↗ NCT02818348 ↗ NCT00838760 ↗ NCT00867152 ↗ NCT02503462 ↗ NCT04236453 ↗ NCT02159599 ↗ NCT01516970 ↗ NCT00994344 ↗ NCT01905059 ↗ NCT00775125 ↗ NCT02097381 ↗ NCT01138605 ↗ NCT02159352 ↗ NCT03163277 ↗ NCT00993148 ↗ NCT00744887 ↗ NCT03892161 ↗ NCT00855413 ↗ NCT00936793 ↗ NCT00855335 ↗ NCT00421551 ↗ NCT00855088 ↗ NCT03589040 ↗ NCT00531557 ↗ NCT00525733 ↗ NCT00524368 ↗ NCT01869634 ↗ NCT01810887 ↗ NCT04388904 ↗ NCT04064632 ↗ NCT02771249 ↗ NCT01294761 ↗ NCT00517192 ↗ NCT00458302 ↗ NCT01013987 ↗ NCT01519336 ↗ NCT00307502 ↗ NCT03675815 ↗ NCT00534352 ↗ NCT02475135 ↗ NCT01258439 ↗ NCT03602690 ↗ NCT01449929 ↗ NCT03864406 ↗ NCT00783484 ↗ NCT07678268 ↗ NCT01374802 ↗ NCT03101644 ↗ NCT04252274 ↗ NCT01066962 ↗ NCT01047995 ↗ NCT01400412 ↗ NCT00752310 ↗ NCT00877591 ↗ NCT01033760 ↗ NCT00630734 ↗ NCT00830804 ↗ NCT00920088 ↗ NCT03683524 ↗ NCT00919854 ↗ NCT02116660 ↗ NCT02671383 ↗ NCT00537394 ↗ NCT02984852 ↗ NCT02275780 ↗ NCT01199939 ↗ NCT00460382 ↗ NCT04183738 ↗ NCT02987530 ↗ NCT01423812 ↗ NCT02431247 ↗ NCT02770508 ↗ NCT00811954 ↗ NCT01343225 ↗ NCT02063360 ↗ NCT02155101 ↗ NCT01323257 ↗ NCT01422369 ↗ NCT04718805 ↗ NCT01073761 ↗ NCT02489487 ↗ NCT03842488 ↗ NCT03123848 ↗ NCT00928187 ↗ NCT01345630 ↗ NCT00849160 ↗ NCT00460746 ↗ NCT02203461 ↗ NCT01736761 ↗ NCT00757783 ↗ NCT01448707 ↗ NCT02384967 ↗ NCT01118871 ↗ NCT01928407 ↗ NCT01281813 ↗ NCT00260078 ↗ NCT02738502 ↗ NCT01695954 ↗ NCT00915655 ↗ NCT01348763 ↗ NCT01876966 ↗ NCT01641367 ↗ NCT04630002 ↗ NCT00543101 ↗ NCT00381303 ↗ NCT03988452 ↗ NCT01367210 ↗ NCT02475915 ↗ NCT03447873 ↗ NCT00885495 ↗ NCT00765271 ↗ NCT03017872 ↗ NCT03394196 ↗ NCT00765154 ↗ NCT00677300 ↗ NCT01274780 ↗ NCT02251795 ↗ NCT00611039 ↗ NCT01605084 ↗ NCT02437110 ↗ NCT03472963 ↗
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 ↗ NCT02337322 ↗ NCT02025868 ↗
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 ↗ “allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)” NCT01475838 ↗ “Darunavir (DRV), emtricitabine (FTC), and tenofovir alafenamide (TAF) in the presence of cobicistat (COBI)” NCT04236453 ↗ “boosted lopinavir (LPV/rtv 200/50 mg 2 tbs BID) or boosted darunavir (DRV 400 mg 2 tbs plus RTV 100 mg QD)” NCT01905059 ↗ “Darunavir (DRV) is an inhibitor of the dimerization and of the catalytic activity of the HIV-1 protease.” NCT05197075 ↗ “Darunavir (DRV): type = exact number, unit = mg, number = 800, form = tablet, route = oral use” NCT01448707 ↗ “It is a combination of two anti-HIV medicines called darunavir (DRV) and ritonavir (RTV).” NCT06139796 ↗ “PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg twice a day” NCT00381303 ↗ “Darunavir (DRV) type=exact number, unit=mg, number=800, form=tablet, route=oral use.” NCT01516970 ↗ “allowed boosted 3rd ARV agents: lopinavir (LPV), atazanavir (ATV), darunavir (DRV)” NCT02285114 ↗ “Darunavir (DRV) 800 mg (2 × 400 mg tablets) administered orally once daily” NCT01565889 ↗ “A tablet containing Darunavir (DRV) 800 mg will be administered.” NCT02475135 ↗ “steady-state darunavir/ritonavir (DRV/rtv) 600/100 mg b.i.d.” NCT00775125 ↗ “Dolutegravir (DTG) plus Darunavir/cobicistat (DRV/cobi).” NCT03683524 ↗ “Darunavir (DRV) in the presence of Cobicistat (COBI)” NCT05378906 ↗ “darunavir (DRV, administered with ritonavir [RTV])” PMID 22288567 ↗ Aug 2012 “BMS-663068 with darunavir (DRV)/cobicistat (COBI)” NCT02277600 ↗ “darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC” NCT02469246 ↗ “Darunavir (DRV) 800 milligram (MG) Oral Tablet” NCT03675815 ↗ “boosted atazanavir (ATV) or darunavir (DRV)” NCT02603107 ↗ “darunavir/ low-dose ritonavir (DRV/rtv)” NCT01281813 ↗ “darunavir (DRV; Prezista®) + COBI” NCT02616783 ↗ “darunavir (DRV; Prezista®) + RTV” NCT02605954 ↗ “Darunavir (DRV)+Ritonavir (rtv)” NCT00919854 ↗ “Darunavir (DRV) 800 mg, 1x/day” NCT06676410 ↗ “Darunavir/Ritonavir (DRV/RTV)” NCT04630002 ↗ “darunavir (DRV, TMC114)” NCT00458302 ↗ “darunavir [DRV]” NCT00665847 ↗ “Darunavir (DRV)” NCT02984852 ↗ “Darunavir (DRV)” NCT02063360 ↗ “darunavir (DRV)” NCT03631732 ↗ “Darunavir (DRV)” NCT00524368 ↗ NCT06337032 ↗ NCT01565850 ↗ NCT01363011 ↗
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 2025 2 “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 2015 9 “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 (PREZISTA™)/ Ritonavir” NCT00534352 ↗ “darunavir (DRV; Prezista®) + RTV” NCT02605954 ↗ “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 2007 12 “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 ↗ NCT00115050 ↗ NCT01702090 ↗ NCT00071097 ↗ NCT00245739 ↗ NCT00854204 ↗ NCT02187107 ↗ NCT00355524 ↗ NCT00650832 ↗ NCT00964327 ↗ NCT00513513 ↗
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 ↗