Raltegravir

also known as RAL · ISENTRESS · MK-0518 · Isentress - Raltegravir · Raltegravir (Isentress) · Insentress · Isentress hd · L-000900612 · +9 more

Other / unclassified

Developed for: HIV infectious disease · hepatitis C virus infection · AIDS · tuberculosis · human T-lymphotropic virus 1 infectious disease · hyperlipidemia · adult T-cell leukemia/lymphoma · chronic hepatitis C virus infection
+12 more
· fatty liver disease · fibrotic liver disease · head and neck cancer · hypertriglyceridemia · metabolic syndrome X · osteoporosis · post-viral disorder · primary biliary cholangitis · proteinuria · relapsing-remitting multiple sclerosis · tropical spastic paraparesis · lipodystrophy
Investigated by: Merck Sharp & Dohme LLC · National Institute of Allergy and Infectious Diseases (NIAID) · ANRS, Emerging Infectious Diseases · Gilead Sciences · Abbott · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
+165 more
· Pfizer · Radboud University Medical Center · Fight AIDS and Infectious Diseases Foundation · Bristol-Myers Squibb · Germans Trias i Pujol Hospital · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Hospital Clinic of Barcelona · University of California, San Francisco · Janssen-Cilag Ltd. · Kirby Institute · McGill University Health Centre/Research Institute of the McGill University Health Centre · National Institute of Mental Health (NIMH) · St Stephens Aids Trust · University of California, San Diego · University of Washington · ViiV Healthcare · Boehringer Ingelheim · California HIV/AIDS Research Program · Community Research Initiative of New England · Fundacion Clinic per a la Recerca Biomédica · Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Imperial College London · Judit Pich · National Institute on Drug Abuse (NIDA) · National Institutes of Health (NIH) · Objectif Recherche Vaccins SIDA · Pedro Cahn · St Vincent's Hospital, Sydney · Tibotec Pharmaceuticals, Ireland · University of Maryland, Baltimore · University of North Carolina, Chapel Hill · Washington University School of Medicine · Yale University · Aaron Diamond AIDS Research Center · AbbVie · Adult AIDS Clinical Trials Group · Allina Health System · Almedis · American Cancer Society, Inc. · Andrew Carr · Association Pour la Recherche en Infectiologie · CIHR Canadian HIV Trials Network · Canadian Immunodeficiency Research Collaborative · Centers for Disease Control and Prevention · Centers for Disease Control and Prevention, China · Central Institute of Epidemiology, Moscow, Russia · Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida · Centre de Sante de Ziguinchor, Casamance, Senegal · Clinique des Maladies Infectieuses, CHNU de Fann, Dakar, Senegal · Covance · Cytheris SA · Dallas VA Medical Center · David A Wohl, MD · Denver Infectious Disease Consultants, PLLC · Department for International Development, United Kingdom · Dimagi Inc. · Dr. Axel Baumgarten, Berlin · Dr. Christoph Stephan, Frankfurt/M · Dr. Jörg Gölz , Berlin · Dr. Keikawus Arastéh, Berlin · Dr. Stefan Esser, Essen · Dr. Thomas Lutz, Frankfurt/M · East Carolina University · Emory University · European and Developing Countries Clinical Trials Partnership (EDCTP) · Felipe Garcia · Fenway Community Health · French National Agency for Research on AIDS and Viral Hepatitis · French National Institute of Health and Medical Research · Fundación Huésped · Fundação Bahiana de Infectologia · George Washington University · all 171 on the full record

Regulatory milestones approvals, filings & regulatory actions · 15 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed HIV infectious disease 2 milestones
Filed	US (FDA)	ISENTRESS	HIV infectious disease	2016-10-25	“The FDA accepted for review a supplemental NDA for a once-daily formulation of ISENTRESS (raltegravir)” merck.com ↗
Filed	EU (EMA)	ISENTRESS	HIV infectious disease	2016-07-22	“Medicines Agency (EMA) has accepted the file for the investigational once-daily formulation of ISENTRESS for review.” merck.com ↗
Approved Indication not stated 3 milestones
Label expansions (11)	US (FDA)	ISENTRESS HD	—	2009-01-29 – 2020-07-14	fda.gov ↗
Approved	EU (EMA)	Isentress	—	2007-12-19	europa.eu ↗
Approved	US (FDA)	ISENTRESS HD	—	2007-10-12	fda.gov ↗

Trials 189 · started per year

today

US approved 2007

EU approved 2007

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 04 trials
Phase 0	NCT03174977	Apr 2018 → Nov 2024	HIV infectious disease	University of California, San Francisco	Unknown	No outcome recorded
Phase 0	NCT02655471	Jul 2017 → Mar 2019	tropical spastic paraparesis	Universidad Peruana Cayetano Heredia	Completed	No outcome recorded
Phase 0	NCT01867320	Sep 2013 → Sep 2018	human T-lymphotropic virus 1 infectious disease	National Institute of Neurological Disorders and Stroke (NINDS)	Completed	No outcome recorded
Phase 0	NCT01275183	Dec 2010 → Apr 2015	head and neck cancer	New Mexico Cancer Research Alliance	Completed	No outcome recorded
Phase 130 trials · 1 missed
Phase 1	NCT03537404	Apr → Jun 2017	—	R-Pharm	Completed	No outcome recorded
Phase 1	NCT02473367	Jun → Aug 2015	HIV infectious disease	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 1	NCT02489487	Sep → Oct 2014	HIV infectious disease	Viriom	Completed	No outcome recorded
Phase 1	NCT01780831	Jan 2014 → Dec 2017	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT01978782	Jan → Apr 2014	HIV infectious disease, depressive disorder	Radboud University Medical Center	Completed	No outcome recorded
Phase 1	NCT01930045	Oct → Dec 2013	HIV infectious disease	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 1	NCT01841593	Apr → Sep 2013	HIV infectious disease	St Stephens Aids Trust	Completed	No outcome recorded
Phase 1	NCT01779687	Mar → Jul 2013	HIV infectious disease, hyperlipidemia	Radboud University Medical Center	Completed	No outcome recorded
Phase 1	NCT01785160	Feb → Mar 2013	—	Boehringer Ingelheim	Completed	Missed primary
Phase 1	NCT01622673	Jun → Oct 2012	HIV infectious disease	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 1	NCT01424826	Jan 2012 → Jun 2013	HIV infectious disease, tuberculosis	Helen Reynolds	Completed	No outcome recorded
Phase 1	NCT01531647	Jan → Mar 2012	—	Hoffmann-La Roche	Completed	No outcome recorded
Phase 1	NCT01288417	Aug → Nov 2011	HIV infectious disease, hepatitis C virus infection	Radboud University Medical Center	Completed	No outcome recorded
Phase 1	NCT01288755	Feb → May 2011	HIV infectious disease	Tibotec Pharmaceuticals, Ireland	Completed	No outcome recorded
Phase 1	NCT01253551	Dec 2010 → Apr 2011	hepatitis C virus infection	Tibotec BVBA	Completed	No outcome recorded
Phase 1	NCT01289951	Dec 2010 → Jun 2011	HIV infectious disease, hepatitis C virus infection	Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal	Completed	No outcome recorded
Phase 1	NCT01246804	Nov 2010 → Mar 2011	HIV infectious disease, cognitive impairment with or without cerebellar ataxia, depressive disorder	Radboud University Medical Center	Completed	No outcome recorded
Phase 1	NCT01241773	Oct 2010 → Apr 2011	hepatitis C virus infection	Tibotec Pharmaceuticals, Ireland	Completed	No outcome recorded
Phase 1	NCT01101893	Apr → Jun 2010	HIV infectious disease	ViiV Healthcare	Completed	No outcome recorded
Phase 1	NCT00772720	Mar 2010 → Mar 2011	—	Hospital Clinic of Barcelona	Unknown	No outcome recorded
Phase 1	NCT02182375	Jan → Mar 2010	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT00982553	Sep → Nov 2009	HIV infectious disease	Imperial College London	Completed	No outcome recorded
Phase 1	NCT00944307	Jul → Dec 2009	HIV infectious disease	University of Colorado, Denver	Completed	No outcome recorded
Phase 1	NCT00809718	Feb 2009 → May 2011	—	The University of Texas Health Science Center at San Antonio	Completed	No outcome recorded
Phase 1	NCT00746499	Sep → Nov 2008	—	University of North Carolina, Chapel Hill	Completed	No outcome recorded
Phase 1	NCT00784420	Sep → Nov 2008	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT00667433	Jun 2008 → Dec 2011	HIV infectious disease	David A Wohl, MD	Completed	No outcome recorded
Phase 1	NCT01000818	Jun 2008 → Mar 2009	HIV infectious disease	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 1	NCT00660972	May 2008 → Jan 2009	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00618241	Feb → Oct 2008	HIV infectious disease	Radboud University Medical Center	Completed	No outcome recorded

Phase 1/26 trials
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	NCT01751568	Nov 2014 → Nov 2019	HIV infectious disease, tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	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	NCT01000285	Sep 2010 → May 2014	adult T-cell leukemia/lymphoma	Washington University School of Medicine	Completed	No outcome recorded
Phase 1/2	NCT01022476	May 2010 → May 2013	HIV infectious disease, liver failure	ANRS, Emerging Infectious Diseases	Completed	No outcome recorded
Phase 1/2	NCT00485264	Sep 2007 → Jun 2013	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 229 trials · 5 missed
Phase 2	NCT03954327	Mar 2021 → Oct 2022	primary biliary cholangitis	University of Alberta	Completed	No outcome recorded
Phase 2	NCT04513626	Sep 2020 → Oct 2025 overdue	HIV infectious disease	Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida	Recruiting	No outcome recorded
Phase 2	NCT03195452	Nov 2017 → Oct 2019	HIV infectious disease	Nantes University Hospital	Completed	No outcome recorded
Phase 2	NCT02212379	Jan 2015 → Oct 2017	HIV infectious disease	ANRS, Emerging Infectious Diseases	Completed	No outcome recorded
Phase 2	NCT02116660	Sep 2014 → Jul 2017	HIV infectious disease	Merck Sharp & Dohme LLC	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT02097108	May 2014 → Dec 2015	HIV infectious disease	Study Group of Medical Tumour Therapy (AGMT)	Completed	No outcome recorded
Phase 2	NCT01601626	Jul 2013 → Jan 2017	HIV infectious disease, tuberculosis	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	Terminated	No outcome recorded
Phase 2	NCT01767701	Apr 2013 → Sep 2014	relapsing-remitting multiple sclerosis	Queen Mary University of London	Completed	No outcome recorded
Phase 2	NCT02025868	Mar 2013 → Aug 2016	HIV infectious disease	ANRS, Emerging Infectious Diseases	Unknown	No outcome recorded
Phase 2	NCT01717287	Nov 2012 → Dec 2013	HIV infectious disease	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 2	NCT01605890	Jul 2012 → Dec 2015	—	ANRS, Emerging Infectious Diseases	Completed	No outcome recorded
Phase 2	NCT01620736	Jan 2012 → Dec 2013	human T-lymphotropic virus 1 infectious disease	Washington University School of Medicine	Withdrawn	No outcome recorded Stop: Business
Phase 2	NCT01231685	Dec 2011 → Mar 2016	HIV infectious disease, fibrotic liver disease, hepatitis C virus infection	McGill University Health Centre/Research Institute of the McGill University Health Centre	Completed	No outcome recorded
Phase 2	NCT01420523	Dec 2011 → Apr 2013	HIV infectious disease, localized lipodystrophy	ANRS, Emerging Infectious Diseases	Terminated	Missed primary
Phase 2	NCT01291459	Sep 2011 → Dec 2015	HIV infectious disease	Association Pour la Recherche en Infectiologie	Unknown	No outcome recorded
Phase 2	NCT01019551	Sep 2010 → Jul 2012	HIV infectious disease	Objectif Recherche Vaccins SIDA	Completed	Missed primary
Phase 2	NCT00976404	Nov 2009 → Jul 2013	HIV infectious disease	Robert L. Murphy	Completed	Missed primary
Phase 2	NCT00807443	Sep 2009 → Dec 2011	HIV infectious disease	Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal	Completed	No outcome recorded
Phase 2	NCT00822315	Jul 2009 → Nov 2011	HIV infectious disease, tuberculosis	ANRS, Emerging Infectious Diseases	Completed	No outcome recorded
Phase 2	NCT00943540	Jul 2009 → Dec 2010	HIV infectious disease	Radboud University Medical Center	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	NCT00768989	Nov 2008 → Jan 2010	HIV infectious disease	Bristol-Myers Squibb	Terminated	No outcome recorded
Phase 2	NCT00752856	Aug 2008 → May 2011	HIV infectious disease	University of California, San Diego	Completed	No outcome recorded
Phase 2	NCT00515827	Nov 2007 → Sep 2008	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Missed primary
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	NCT00520897	Apr 2007 → Feb 2009	HIV infectious disease	Canadian Immunodeficiency Research Collaborative	Completed	No outcome recorded
Phase 2	NCT00614458	Apr 2007 → Sep 2008	HIV infectious disease	University of North Carolina, Chapel Hill	Terminated	Missed primary Stop: Business
Phase 2	NCT00105157	Mar 2005 → Oct 2006	AIDS	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 2	NCT00100048	Jan 2005 → Oct 2006	AIDS	Merck Sharp & Dohme LLC	Completed	No outcome recorded

Phase 2/35 trials · 1 met primary · 3 missed
Phase 2/3	NCT02150993	Jan 2016 → May 2019	—	ANRS, Emerging Infectious Diseases	Completed	No outcome recorded
Phase 2/3	NCT01854762	Jun 2015 → Aug 2017	HIV infectious disease, pregnancy disorder	Fundação Bahiana de Infectologia	Terminated	Met primary
Phase 2/3	NCT01154673	Nov 2011 → Sep 2014	—	University of Toronto	Completed	Missed primary
Phase 2/3	NCT00729924	Aug 2008 → Feb 2011	HIV infectious disease	Vanderbilt University	Completed	Missed primary
Phase 2/3	NCT00624195	Mar 2007 → Feb 2012	HIV infectious disease	University of California, San Diego	Completed	Missed primary
Phase 333 trials · 8 met primary · 4 missed
Phase 3	NCT04051970	Nov 2019 → Jun 2022	HIV infectious disease	ANRS, Emerging Infectious Diseases	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT03333083	May 2018 → Jun 2020	HIV infectious disease	Judit Pich	Terminated	No outcome recorded
Phase 3	NCT03311945	May 2018 → Mar 2021	HIV infectious disease	Judit Pich	Completed	No outcome recorded
Phase 3	NCT03029689	Jul 2017 → Apr 2020	HIV infectious disease	Fight AIDS and Infectious Diseases Foundation	Completed	No outcome recorded
Phase 3	NCT02284035	Sep 2015 → Feb 2017	AIDS	Juan A. Arnaiz	Completed	No outcome recorded
Phase 3	NCT02131233	May 2014 → Dec 2015	HIV infectious disease	Merck Sharp & Dohme LLC	Completed	Met primary
Phase 3	NCT01900106	Nov 2013 → Dec 2017	HIV infectious disease	University of Modena and Reggio Emilia	Completed	No outcome recorded
Phase 3	NCT01896921	Sep 2013 → Dec 2018	HIV infectious disease	University of Maryland, Baltimore	Completed	No outcome recorded
Phase 3	NCT01825031	Jun 2013 → Mar 2016	HIV infectious disease	Medical Research Council	Completed	Missed primary
Phase 3	NCT01697046	Nov 2012 → Mar 2014	HIV infectious disease	Projeto Praça Onze	Unknown	No outcome recorded
Phase 3	NCT01480713	May 2012 → May 2014	HIV infectious disease	IrsiCaixa	Completed	No outcome recorded
Phase 3	NCT01352715	Mar 2012 → Oct 2014	HIV infectious disease	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	Completed	Met primary
Phase 3	NCT01453192	Dec 2011 → Nov 2015	HIV infectious disease, chronic renal failure syndrome	ANRS, Emerging Infectious Diseases	Completed	Met primary
Phase 3	NCT01114425	Nov 2010 → Aug 2012	HIV infectious disease	Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux	Completed	No outcome recorded
Phase 3	NCT01195467	Oct 2010 → Jun 2013	HIV infectious disease	St Stephens Aids Trust	Completed	No outcome recorded
Phase 3	NCT00935480	Oct → Nov 2010	HIV infectious disease	Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer	Completed	Missed primary
Phase 3	NCT01066962	Aug 2010 → Oct 2013	HIV infectious disease	ANRS, Emerging Infectious Diseases	Completed	Met primary
Phase 3	NCT01033760	Apr 2010 → Jul 2013	HIV infectious disease	ANRS, Emerging Infectious Diseases	Completed	Missed primary
Phase 3	NCT00988039	Mar 2010 → Jan 2014	HIV infectious disease	Medical Research Council	Completed	Missed primary
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	NCT00887653	May 2009 → Jun 2012	HIV infectious disease, hyperlipidemia, hypertriglyceridemia	The Miriam Hospital	Completed	No outcome recorded
Phase 3	NCT00764946	Oct 2008 → Feb 2011	HIV infectious disease	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 3	NCT00562510	Aug 2008 → Dec 2010	HIV infectious disease	Pedro Cahn	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00711009	Jul 2008 → Nov 2009	HIV infectious disease	Abbott	Completed	Met primary
Phase 3	NCT00528892	Jan 2008 → Mar 2010	HIV infectious disease	Hospital Clinic of Barcelona	Completed	Met primary
Phase 3	NCT00537394	Jan 2008 → May 2012	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Met primary
Phase 3	NCT00554398	Nov 2007 → May 2009	HIV infectious disease	Germans Trias i Pujol Hospital	Completed	No outcome recorded
Phase 3	NCT00529243	Sep 2007 → Jul 2008	HIV infectious disease	Kaiser Permanente	Completed	No outcome recorded
Phase 3	NCT00443729	May 2007 → Oct 2008	HIV infectious disease	Merck Sharp & Dohme LLC	Terminated	No outcome recorded
Phase 3	NCT00443703	May 2007 → Apr 2009	HIV infectious disease	Merck Sharp & Dohme LLC	Terminated	No outcome recorded
Phase 3	NCT00369941	Aug 2006 → May 2009	HIV infectious disease	Merck Sharp & Dohme LLC	Completed	Met primary
Phase 3	NCT00293254	Feb 2006 → Oct 2007	HIV infectious disease	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 3	NCT00293267	Feb 2006 → Aug 2007	HIV infectious disease	Merck Sharp & Dohme LLC	Completed	No outcome recorded

Phase 456 trials · 1 met primary · 5 missed
Phase 4	NCT06337032	Aug 2024 → Mar 2034 expected	HIV infectious disease	Gilead Sciences	Recruiting	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	NCT04258475	Dec 2020 → Jun 2024	—	Ottawa Hospital Research Institute	Unknown	No outcome recorded
Phase 4	NCT03732625	May 2019 → Jan 2020	HIV infectious disease	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud	Unknown	No outcome recorded
Phase 4	NCT03842488	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	NCT03667547	Sep → Oct 2018	HIV infectious disease	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 4	NCT03374358	Jan 2018 → Nov 2019	fatty liver disease, metabolic syndrome X	Helsinki University Central Hospital	Completed	No outcome recorded
Phase 4	NCT02691065	Jan 2017 → Mar 2021	HIV infectious disease	McGill University Health Centre/Research Institute of the McGill University Health Centre	Completed	No outcome recorded
Phase 4	NCT02577042	Oct 2015 → Jun 2018	—	Fight AIDS and Infectious Diseases Foundation	Completed	No outcome recorded
Phase 4	NCT02383355	Mar 2015 → Mar 2016	HIV infectious disease	Radboud University Medical Center	Completed	Missed primary
Phase 4	NCT02351908	Mar 2015 → Apr 2016	HIV infectious disease	St Stephens Aids Trust	Completed	No outcome recorded
Phase 4	NCT02210715	Mar 2015 → Jan 2019	HIV infectious disease, metabolic dysfunction-associated steatohepatitis	McGill University Health Centre/Research Institute of the McGill University Health Centre	Completed	No outcome recorded
Phase 4	NCT01902186	Sep 2014 → Dec 2016	HIV infectious disease	Giovanni Di Perri	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01829802	May 2014 → Oct 2017	HIV infectious disease	Pedro Cahn	Unknown	No outcome recorded
Phase 4	NCT01147107	Feb 2014 → Jun 2016	HIV infectious disease, chronic hepatitis C virus infection	University of Hawaii	Completed	No outcome recorded
Phase 4	NCT01618305	Sep 2013 → Dec 2018	HIV infectious disease	Westat	Completed	Mixed
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	NCT01576731	Jul 2012 → Jul 2014	HIV infectious disease	Hospital Clinic of Barcelona	Completed	Missed primary
Phase 4	NCT01679964	Jul 2012 → Feb 2015	HIV infectious disease	Lin, Hsi-Hsun, M.D.	Completed	No outcome recorded
Phase 4	NCT01529749	Feb → Mar 2012	HIV infectious disease	Felipe Garcia	Completed	No outcome recorded
Phase 4	NCT01332227	Oct 2011 → Sep 2013	—	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 4	NCT01448486	Oct 2011 → Oct 2013	HIV infectious disease, post-viral disorder	St Vincent's Hospital, Sydney	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01214759	May 2011 → Dec 2013	HIV infectious disease	The University of Texas Health Science Center, Houston	Completed	No outcome recorded
Phase 4	NCT01343225	May 2011 → May 2014	HIV infectious disease	East Carolina University	Unknown	No outcome recorded
Phase 4	NCT01270802	Apr 2011 → Oct 2012	HIV infectious disease	Indiana University	Completed	Missed primary
Phase 4	NCT01335620	Apr 2011 → Dec 2012	HIV infectious disease	Imperial College London	Completed	No outcome recorded
Phase 4	NCT01285050	Jan 2011 → Apr 2015	HIV infectious disease, hepatitis C virus infection	Johns Hopkins University	Completed	No outcome recorded
Phase 4	NCT01059422	Oct 2010 → Mar 2013	HIV infectious disease, tuberculosis	Central Institute of Epidemiology, Moscow, Russia	Completed	No outcome recorded
Phase 4	NCT01225705	Oct 2010 → Aug 2012	HIV infectious disease, hepatitis C virus infection	University Hospital, Bonn	Withdrawn	No outcome recorded Stop: Enrollment
Phase 4	NCT01201239	Sep 2010 → May 2012	HIV infectious disease	Shanghai Public Health Clinical Center	Unknown	No outcome recorded
Phase 4	NCT01173510	Aug 2010 → Oct 2012	AIDS	Community Research Initiative of New England	Withdrawn	No outcome recorded
Phase 4	NCT01105611	Aug 2010 → Dec 2012	HIV infectious disease, hepatitis C virus infection	St. James's Hospital, Ireland	Unknown	No outcome recorded
Phase 4	NCT01087840	Jul 2010 → May 2012	HIV infectious disease	Andrew Carr	Completed	No outcome recorded
Phase 4	NCT01121809	Apr → Oct 2010	HIV infectious disease	Hospitales Universitarios Virgen del Rocío	Completed	No outcome recorded
Phase 4	NCT01013987	Feb 2010 → ?	AIDS	Fundación Huésped	Unknown	No outcome recorded
Phase 4	NCT00955968	Jan 2010 → Aug 2016	HIV infectious disease	International Maternal Pediatric Adolescent AIDS Clinical Trials Group	Completed	No outcome recorded
Phase 4	NCT00931801	Dec 2009 → Feb 2012	HIV infectious disease	Community Research Initiative of New England	Completed	No outcome recorded
Phase 4	NCT01025427	Dec 2009 → Nov 2012	HIV infectious disease	University of California, San Francisco	Completed	No outcome recorded
Phase 4	NCT00995241	Nov → Dec 2009	HIV infectious disease	Germans Trias i Pujol Hospital	Completed	No outcome recorded
Phase 4	NCT00939874	Oct 2009 → Jun 2012	HIV infectious disease, osteoporosis	St Vincent's Hospital, Sydney	Completed	No outcome recorded
Phase 4	NCT00931463	Sep 2009 → Sep 2012	HIV infectious disease	Kirby Institute	Completed	Met primary
Phase 4	NCT00773708	Mar 2009 → May 2011	HIV infectious disease	Germans Trias i Pujol Hospital	Completed	No outcome recorded
Phase 4	NCT00772590	Mar 2009 → Mar 2010	HIV infectious disease	Kirby Institute	Completed	No outcome recorded
Phase 4	NCT00781287	Feb 2009 → Feb 2012	HIV infectious disease	University of Washington	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT00677300	Jan 2009 → Oct 2012	HIV infectious disease	Dallas VA Medical Center	Completed	Missed primary
Phase 4	NCT00941083	Jan → Dec 2009	HIV infectious disease	Hospital Carlos III, Madrid	Unknown	No outcome recorded
Phase 4	NCT00752037	Sep 2008 → Apr 2010	HIV infectious disease	Saint Michael's Medical Center	Completed	No outcome recorded
Phase 4	NCT00718536	Aug 2008 → Jan 2009	HIV infectious disease	Germans Trias i Pujol Hospital	Completed	No outcome recorded
Phase 4	NCT00700115	Jun 2008 → Jan 2011	HIV infectious disease	Emory University	Completed	No outcome recorded
Phase 4	NCT00685191	Jun 2008 → Apr 2009	HIV infectious disease	Germans Trias i Pujol Hospital	Completed	No outcome recorded
Phase 4	NCT00740064	May 2008 → Aug 2009	HIV infectious disease	Denver Infectious Disease Consultants, PLLC	Unknown	No outcome recorded
Phase 4	NCT00751153	Mar 2008 → Oct 2009	HIV infectious disease	Peter J. Ruane, M.D., Inc.	Unknown	No outcome recorded
Phase 4	NCT00666705	Feb → Mar 2008	—	ViiV Healthcare	Completed	No outcome recorded
Phase 4	NCT00632970	Feb 2008 → Feb 2010	HIV infectious disease	George Washington University	Terminated	No outcome recorded
Phase 4	NCT00594646	Feb 2008 → Mar 2010	HIV infectious disease	Fenway Community Health	Completed	No outcome recorded
Phase 4	NCT00564772	Nov → Dec 2007	—	Allina Health System	Completed	No outcome recorded

Phase not applicable25 trials · 3 missed
—	NCT03394196	Jul 2018 → May 2020	—	University of Washington	Terminated	No outcome recorded Stop: Business
—	NCT01978743	Jan 2014 → Sep 2016	AIDS dementia complex, HIV infectious disease, poisoning	Massachusetts General Hospital	Completed	No outcome recorded
—	NCT01293123	Dec 2011 → Jun 2013	HIV infectious disease	University of California, San Diego	Terminated	No outcome recorded Stop: Enrollment
—	NCT01327482	Oct 2011 → Dec 2012	HIV infectious disease	University of Washington	Completed	No outcome recorded
—	NCT01318096	Mar 2011 → Jul 2012	HIV infectious disease	Yunnan AIDS Care Center	Unknown	No outcome recorded
—	NCT01294761	Feb 2011 → Feb 2012	HIV infectious disease	National Center for Global Health and Medicine, Japan	Completed	Missed primary
—	NCT01042652	Feb 2011 → Jan 2012	HIV infectious disease	Centers for Disease Control and Prevention, China	Unknown	No outcome recorded
—	NCT01214486	Oct 2010 → Apr 2011	HIV infectious disease	University of Nebraska	Completed	No outcome recorded
—	NCT01164605	Oct 2010 → Jun 2013	HIV infectious disease	Southern California Institute for Research and Education	Unknown	No outcome recorded
—	NCT01204905	Sep 2010 → May 2014	HIV infectious disease	University of Maryland, Baltimore	Completed	No outcome recorded
—	NCT01044771	Jan → Dec 2010	HIV infectious disease, proteinuria	Metropolis Medical	Completed	No outcome recorded
—	NCT00944957	Nov → Dec 2009	HIV infectious disease, sleep disorder	University Hospital, Geneva	Unknown	No outcome recorded
—	NCT00814879	May 2009 → May 2013	AIDS	Yale University	Completed	No outcome recorded
—	NCT00863668	Mar 2009 → Mar 2010	HIV infectious disease	University of Minnesota	Withdrawn	No outcome recorded
—	NCT00858962	Mar → Dec 2009	HIV infectious disease	Yale University	Completed	No outcome recorded
—	NCT00749580	Nov 2008 → Jul 2011	HIV infectious disease	University of South Florida	Completed	No outcome recorded
—	NCT00787774	Nov 2008 → Jan 2010	HIV infectious disease	Hospital Clinic of Barcelona	Unknown	No outcome recorded
—	NCT00884793	Sep 2008 → Dec 2009	HIV infectious disease	University of California, San Francisco	Completed	No outcome recorded
—	NCT00745368	Sep 2008 → Jun 2011	HIV infectious disease	University of Rochester	Completed	No outcome recorded
—	NCT00738569	Jul 2008 → Feb 2011	HIV infectious disease	National Jewish Health	Completed	No outcome recorded
—	NCT00672932	Apr 2008 → Oct 2010	HIV infectious disease	University of California, San Francisco	Completed	Missed primary
—	NCT00641641	Mar 2008 → Mar 2011	HIV infectious disease	Kirby Institute	Completed	No outcome recorded
—	NCT00525733	Oct 2007 → Dec 2013	HIV infectious disease	Rockefeller University	Completed	No outcome recorded
—	NCT00523237	Oct 2007 → Mar 2009	HIV infectious disease	Stanford University	Completed	No outcome recorded
—	NCT00618371	Oct 2007 → Mar 2009	HIV infectious disease	University of Pittsburgh	Completed	Missed primary

Phase not stated1 trial
—	NCT00377065	—	HIV infectious disease	Merck Sharp & Dohme LLC	Approved for marketing	No outcome recorded
Comparator or background therapy62 trials
Phase 1	NCT03060447 Background	May 2017 → Feb 2020	HIV infectious disease	Gilead Sciences	Completed	No outcome recorded
Phase 1	NCT01784302 Comparator	Apr 2014 → Feb 2016	HIV infectious disease	Helen Reynolds	Completed	No outcome recorded
Phase 1	NCT01325051 Comparator	Apr → Nov 2011	—	Angela Kashuba, PharmD	Completed	No outcome recorded
Phase 1	NCT01027182 Comparator	Dec 2009 → Mar 2010	HIV infectious disease	Changi General Hospital	Completed	No outcome recorded
Phase 1	NCT01047995 Comparator	Jun → Dec 2009	HIV infectious disease	St Stephens Aids Trust	Completed	No outcome recorded
Phase 1	NCT00772551 Comparator	Jun → Aug 2008	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	NCT00665717 Comparator	May → Sep 2008	HIV infectious disease	Radboud University Medical Center	Completed	No outcome recorded
Phase 1	NCT00531999 Comparator	Oct 2007 → Aug 2008	HIV infectious disease	St Stephens Aids Trust	Completed	No outcome recorded
Phase 1	NCT00518297 Comparator	Aug → Dec 2007	HIV infectious disease	Bristol-Myers Squibb	Completed	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	NCT06338826 Background	Feb 2025 → Sep 2027 expected	HIV infectious disease	ANRS, Emerging Infectious Diseases	Not yet recruiting	No outcome recorded
Phase 2	NCT04012931 Background	Jul 2019 → Feb 2023	HIV infectious disease	Janssen Research & Development, LLC	Completed	No outcome recorded
Phase 2	NCT02336074 Background	Nov 2015 → Nov 2017	HIV infectious disease	Imperial College London	Completed	Missed primary
Phase 2	NCT01384734 Background	Jul 2011 → Feb 2013	HIV infectious disease	ViiV Healthcare	Completed	No outcome recorded
Phase 2	NCT01159132 Comparator	Apr → Dec 2010	HIV infectious disease	The HIV Netherlands Australia Thailand Research Collaboration	Completed	No outcome recorded
Phase 2	NCT00958100 Background	Aug 2009 → Nov 2010	AIDS	Catholic University of the Sacred Heart	Completed	No outcome recorded
Phase 2	NCT00656175 Comparator	Sep 2008 → Dec 2011	HIV infectious disease, lipodystrophy	University of California, Los Angeles	Completed	No outcome recorded
Phase 2	NCT00654147 Comparator	Apr 2008 → Jan 2012	HIV infectious disease	Margaret A. Fischl, M.D.	Completed	No outcome recorded
Phase 2/3	NCT02285114 Background	Jan 2015 → Nov 2019	—	Gilead Sciences	Completed	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	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	NCT02273765 Comparator	Sep 2015 → Nov 2018	HIV infectious disease, tuberculosis	ANRS, Emerging Infectious Diseases	Completed	Missed 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	NCT02247687 Comparator	Dec 2014 → Sep 2015	HIV infectious disease	ANRS, Emerging Infectious Diseases	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT02219672 Comparator	Jul 2014 → Jul 2016	AIDS	Peking Union Medical College	Unknown	No outcome recorded
Phase 3	NCT02121795 Background	May 2014 → Aug 2015	HIV infectious disease	Gilead Sciences	Completed	Met primary
Phase 3	NCT00984152 Comparator	Jun 2011 → Jun 2013	HIV infectious disease	Rush University Medical Center	Withdrawn	No outcome recorded
Phase 3	NCT01231516 Comparator	Oct 2010 → Feb 2013	HIV infectious disease	ViiV Healthcare	Completed	Met primary
Phase 3	NCT01227824 Comparator	Oct 2010 → Feb 2012	HIV infectious disease	ViiV Healthcare	Completed	Met primary
Phase 3	NCT00874523 Comparator	Jul 2009 → Jul 2011	HIV infectious disease	Kirby Institute	Completed	No outcome recorded
Phase 3	NCT00808002 Background	Feb 2009 → Nov 2011	HIV infectious disease	Germans Trias i Pujol Hospital	Completed	No outcome recorded
Phase 3	NCT00745823 Comparator	Sep 2008 → Oct 2010	HIV infectious disease	Merck Sharp & Dohme LLC	Terminated	No outcome recorded
Phase 3	NCT00708162 Comparator	Jul 2008 → Dec 2010	HIV infectious disease	Gilead Sciences	Completed	Met primary
Phase 3	NCT00440271 Background	Feb 2007 → Oct 2008	HIV infectious disease	Boehringer Ingelheim	Terminated	No outcome recorded
Phase 4	NCT04442737 Comparator	Jul 2020 → Aug 2023	—	Janssen Scientific Affairs, LLC	Completed	Missed primary
Phase 4	NCT03205566 Comparator	Sep 2017 → Sep 2018	HIV infectious disease	Guy's and St Thomas' NHS Foundation Trust	Completed	No outcome recorded
Phase 4	NCT01900015 Comparator	Feb 2014 → Jan 2017	HIV infectious disease, hepatitis C virus infection	Juan Macías	Completed	No outcome recorded
Phase 4	NCT01989910 Comparator	Sep 2013 → Dec 2015	HIV infectious disease	Taipei Veterans General Hospital, Taiwan	Completed	No outcome recorded
Phase 4	NCT01453933 Comparator	Jan 2012 → Oct 2014	HIV infectious disease	UMC Utrecht	Unknown	No outcome recorded
Phase 4	NCT01234116 Comparator	Feb 2011 → May 2013	HIV infectious disease	Henry Ford Health System	Completed	No outcome recorded
Phase 4	NCT01189695 Comparator	Dec 2010 → Dec 2012	AIDS	Bamrasnaradura Infectious Diseases Institute	Completed	No outcome recorded
Phase 4	NCT01245101 Comparator	Nov 2010 → Oct 2012	HIV infectious disease	University of Miami	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01258439 Comparator	Nov 2010 → Jul 2014	HIV infectious disease, cardiovascular disorder	St Vincent's Hospital, Sydney	Completed	No outcome recorded
Phase 4	NCT00808184 Comparator	Apr 2010 → Feb 2012	neoplasm	National University Hospital, Singapore	Completed	No outcome recorded
Phase 4	NCT01513122 Comparator	Feb 2010 → Sep 2012	HIV infectious disease	Kirby Institute	Completed	No outcome recorded
Phase 4	NCT00870363 Comparator	Apr 2009 → Apr 2013	HIV infectious disease	University of California, Davis	Completed	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	NCT00762892 Comparator	Jan 2009 → Dec 2012	HIV infectious disease	The University of Texas Health Science Center, Houston	Completed	No outcome recorded
Phase 4	NCT00843713 Comparator	Jan 2009 → Nov 2013	HIV infectious disease, cardiovascular disorder	University of California, San Francisco	Completed	No outcome recorded
Phase 4	NCT00631449 Comparator	Feb 2008 → Sep 2009	HIV infectious disease	University of California, San Francisco	Completed	No outcome recorded
—	NCT05044962 Comparator	Nov 2021 → Mar 2027 expected	HIV infectious disease	University of Alabama at Birmingham	Recruiting	No outcome recorded
—	NCT01844310 Comparator	May 2013 → Dec 2015	AIDS	Peking Union Medical College	Unknown	No outcome recorded
—	NCT01450189 Comparator	Oct 2011 → Jul 2014	HIV infectious disease	University of North Carolina, Chapel Hill	Completed	No outcome recorded
—	NCT00802074 Comparator	Dec 2008 → Mar 2009	—	Garden State Infectious Disease Associates, PA	Completed	No outcome recorded
—	NCT00734344 Comparator	Sep 2008 → Aug 2012	—	University of Alabama at Birmingham	Completed	No outcome recorded
—	NCT00661960 Comparator	Mar 2008 → Sep 2010	AIDS	University of California, Davis	Completed	No outcome recorded
—	NCT00614991 Comparator	Jan → Mar 2008	—	Garden State Infectious Disease Associates, PA	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 22

Date	Issuer	Release
2025-05-08	Lupin Limited	Regulatory Lupin Receives Approval from U.S. FDA for Raltegravir Tablets USP, 600 mg lupin.com ↗ Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Raltegravir Tablets USP, 600 mg.
2024-11-08	Lupin Limited	Regulatory Lupin Receives Tentative Approval from U.S. FDA for Raltegravir Tablets, USP lupin.com ↗
2017-11-29	Merck Sharp & Dohme LLC	Regulatory Merck Receives FDA Approval for ISENTRESS® (raltegravir), in Combination with Other Antiretroviral Agents, for the Treatment of HIV-1 Infection in Newborns Weighing at Least 2 kg merck.com ↗ With this FDA approval, ISENTRESS becomes the only integrase inhibitor approved in the U.S. for the treatment of HIV-1, in combination with other antiretroviral agents, for neonates weighing at least 2 kg.
2017-07-24	Merck Sharp & Dohme LLC	Results Merck Announces Week 96 Results from ONCEMRK, A Study Evaluating Once-Daily ISENTRESS® HD (raltegravir), in Combination with Other Antiretroviral Agents, for the Treatment of HIV-1 Infection in Appropriate Patients merck.com ↗ The Week 96 results reaffirm the comparable efficacy and safety of ISENTRESS HD.
2017-05-30	Merck Sharp & Dohme LLC	Regulatory Merck Receives FDA Approval of ISENTRESS® HD (raltegravir), a New Once-Daily Option, in Combination with Other Antiretroviral Agents, for the Treatment of HIV-1 Infection in Appropriate Patients merck.com ↗
2017-05-19	Merck Sharp & Dohme LLC	Regulatory Merck Receives CHMP Positive Opinion Recommending Approval of ISENTRESS® (raltegravir) 600 mg in the European Union merck.com ↗
2016-07-22	Merck Sharp & Dohme LLC	Results Data for Merck’s Investigational Once-Daily Formulation of ISENTRESS® (raltegravir) Show That at Week 48, a Regimen Containing the Once-Daily Dosing Formulation… merck.com ↗ Furthermore, the study showed comparable rates of reported drug-related clinical adverse events and rates of discontinuation between the two treatment groups.
2016-02-22	Merck Sharp & Dohme LLC	Results Merck’s Investigational Once-Daily Formulation of ISENTRESS® (raltegravir) Meets Primary and Secondary Endpoints in Pivotal Phase 3 Study merck.com ↗ In addition, the secondary endpoints of tolerability and immunologic efficacy (as measured by change from baseline in CD4 cell counts at Week 48) were comparable.
2014-06-24	Merck Sharp & Dohme LLC	Regulatory FDA Accepts Merck’s NDA for Fixed-Dose Combination of Raltegravir with Lamivudine merck.com ↗ Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for a fixed-dose combination (FDC) of raltegravir with lamivudine for the treatment of HIV-1 infection (MK-0518B) has been accepted for standard review by the U.S. Food and Drug Administration (FDA).
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.
2014-01-08	Merck Sharp & Dohme LLC	Regulatory Merck Receives FDA Approval for ISENTRESS® (raltegravir) for Pediatric Oral Suspension merck.com ↗ With this approval, ISENTRESS is now indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in patients four weeks of age and older.
2013-07-01	Merck Sharp & Dohme LLC	Regulatory FDA Approves New U.S. Labeling for ISENTRESS® (raltegravir) to Include 240-Week Results from STARTMRK Study of ISENTRESS Containing Regimen in Previously Untreated HIV-1 Infected Adult Patients merck.com ↗ The updated prescribing information now includes 240-week results from the STARTMRK study, the longest double-blind Phase III non-inferiority study evaluating an integrase inhibitor in treatment-naïve adult patients with HIV-1 infection.
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.
2012-07-24	Gilead Sciences	Results Gilead’s HIV Integrase Inhibitor Elvitegravir Dosed Once Daily as Effective as Twice-Daily Raltegravir Over Two Years of Therapy in Pivotal Phase 3 Study gilead.com ↗ Gilead Sciences, Inc. (Nasdaq: GILD) today announced two-year Phase 3 clinical trial results showing that the integrase inhibitor elvitegravir dosed once daily is non-inferior to raltegravir dosed twice daily among treatment-experienced HIV patients.
2012-07-22	Merck Sharp & Dohme LLC	Results ISENTRESS® (raltegravir) in Combination Therapy Demonstrated Long-Term Efficacy, Safety and Tolerability in Previously Untreated Adult Patients with HIV-1 for up to 240 Weeks merck.com ↗ In this pre-specified exploratory analysis of ISENTRESS ® (raltegravir) 400 mg Film-coated Tablets in combination therapy in previously untreated (treatment-naïve) adult HIV-1 patients, virologic efficacy was better than the efavirenz-based regimen at 240 weeks.
2012-05-21	Merck Sharp & Dohme LLC	Regulatory FDA Approves New Labeling for ISENTRESS® (raltegravir) to Include 156-Week Data Demonstrating Long-Term Efficacy, Safety and Tolerability with ISENTRESS in Combination Therapy in Previously Untreated Adult Patients Infected with HIV-1 merck.com ↗
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.
2012-01-06	Merck Sharp & Dohme LLC	Regulatory FDA Approves Merck’s ISENTRESS® (raltegravir) for Use in Children Ages Two Years and Older as Part of HIV-1 Combination Therapy merck.com ↗ Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) recently approved the use of ISENTRESS® (raltegravir) in combination with other antiretroviral (ARV) medicines, for the treatment of HIV-1 infection in pediatric patients two years of age and older and weighing at least 10 kg.
2011-10-13	Merck Sharp & Dohme LLC	Results Merck’s ISENTRESS® (raltegravir) in Combination Therapy Demonstrated Virological and Immunological Efficacy Versus the Efavirenz Regimen at 192 Weeks of Treatment in Previously Untreated Adults with HIV-1 merck.com ↗ These results offer further insight into the virologic and immunologic response seen with ISENTRESS in combination therapy when compared to efavirenz at 192 weeks in treatment-naïve adult patients with HIV-1,” said Dr. Jürgen Rockstroh, University of Bonn, Bonn-Venusberg, Germany, who presented the data.
2011-09-19	Merck Sharp & Dohme LLC	Results Merck’s ISENTRESS® (raltegravir) in Combination Therapy Demonstrated Efficacy and Tolerability in an Observational Trial in a Diverse Population of Adults with HIV-1 Regardless of Gender or Race merck.com ↗
2011-07-20	Gilead Sciences	Results Gilead's Investigational Antiretroviral Elvitegravir Once Daily Non-Inferior to Raltegravir Twice Daily at 48 Weeks gilead.com ↗ Discontinuation rates due to adverse events, and safety and resistance profiles were comparable in both arms of the study.
2011-03-23	Gilead Sciences	Results Phase III Clinical Trial of Gilead's Investigational Elvitegravir Meets 48-Week Primary Objective gilead.com ↗ The primary endpoint analysis indicated that 59.0 percent of patients in the elvitegravir arm compared to 57.8 percent in the raltegravir arm (95% CI for the difference: -6.0% to +8.2%) achieved and maintained a viral load of less than 50 copies/mL through week 48.

All press releases naming this drug 26 releases

Date	Issuer	Release
2025-05-08	Lupin Limited	Lupin Receives Approval from U.S. FDA for Raltegravir Tablets USP, 600 mg lupin.com ↗
2024-11-08	Lupin Limited	Lupin Receives Tentative Approval from U.S. FDA for Raltegravir Tablets, USP lupin.com ↗
2017-11-29	Merck Sharp & Dohme LLC	Merck Receives FDA Approval for ISENTRESS® (raltegravir), in Combination with Other Antiretroviral Agents, for the Treatment of HIV-1 Infection in Newborns Weighing at Least 2 kg merck.com ↗
2017-07-24	Merck Sharp & Dohme LLC	Merck Announces Week 96 Results from ONCEMRK, A Study Evaluating Once-Daily ISENTRESS® HD (raltegravir), in Combination with Other Antiretroviral Agents, for the Treatment of HIV-1 Infection in Appropriate Patients merck.com ↗
2017-07-06	Merck Sharp & Dohme LLC	Merck to Present New Data from Clinical Trials Evaluating ISENTRESS® HD (raltegravir) and Investigational HIV Therapies Doravirine and MK-8591 at IAS 2017 merck.com ↗
2017-05-30	Merck Sharp & Dohme LLC	Merck Receives FDA Approval of ISENTRESS® HD (raltegravir), a New Once-Daily Option, in Combination with Other Antiretroviral Agents, for the Treatment of HIV-1 Infection in Appropriate Patients merck.com ↗
2017-05-19	Merck Sharp & Dohme LLC	Merck Receives CHMP Positive Opinion Recommending Approval of ISENTRESS® (raltegravir) 600 mg in the European Union merck.com ↗
2016-07-22	Merck Sharp & Dohme LLC	Data for Merck’s Investigational Once-Daily Formulation of ISENTRESS® (raltegravir) Show That at Week 48, a Regimen Containing the Once-Daily Dosing Formulation… merck.com ↗
2016-02-22	Merck Sharp & Dohme LLC	Merck’s Investigational Once-Daily Formulation of ISENTRESS® (raltegravir) Meets Primary and Secondary Endpoints in Pivotal Phase 3 Study merck.com ↗
2015-02-24	Merck Sharp & Dohme LLC	Merck Announces Collaboration with the Medicines Patent Pool to Expand Access to Pediatric Formulations of Raltegravir in Developing Countries merck.com ↗
2014-06-24	Merck Sharp & Dohme LLC	FDA Accepts Merck’s NDA for Fixed-Dose Combination of Raltegravir with Lamivudine merck.com ↗
2014-06-05	Merck Sharp & Dohme LLC	First Patient Enrolled in New Phase 3 Trial Program Investigating a Once-Daily Dosing Regimen of ISENTRESS® (raltegravir) merck.com ↗
2014-03-05	Merck Sharp & Dohme LLC	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 ↗
2014-01-08	Merck Sharp & Dohme LLC	Merck Receives FDA Approval for ISENTRESS® (raltegravir) for Pediatric Oral Suspension merck.com ↗
2013-10-16	Merck Sharp & Dohme LLC	Merck Presents New Pharmacokinetic Data on ISENTRESS® (raltegravir) at 14th European AIDS Conference merck.com ↗
2013-07-01	Merck Sharp & Dohme LLC	FDA Approves New U.S. Labeling for ISENTRESS® (raltegravir) to Include 240-Week Results from STARTMRK Study of ISENTRESS Containing Regimen in Previously Untreated HIV-1 Infected Adult Patients merck.com ↗
2013-03-06	GlaxoSmithKline	ViiV Healthcare presents data from Phase III study of dolutegravir vs raltegravir in treatment-experienced adults with HIV-1 gsk.com ↗
2012-07-24	Gilead Sciences	Gilead’s HIV Integrase Inhibitor Elvitegravir Dosed Once Daily as Effective as Twice-Daily Raltegravir Over Two Years of Therapy in Pivotal Phase 3 Study gilead.com ↗
2012-07-22	Merck Sharp & Dohme LLC	ISENTRESS® (raltegravir) in Combination Therapy Demonstrated Long-Term Efficacy, Safety and Tolerability in Previously Untreated Adult Patients with HIV-1 for up to 240 Weeks merck.com ↗
2012-05-21	Merck Sharp & Dohme LLC	FDA Approves New Labeling for ISENTRESS® (raltegravir) to Include 156-Week Data Demonstrating Long-Term Efficacy, Safety and Tolerability with ISENTRESS in Combination Therapy in Previously Untreated Adult Patients Infected with HIV-1 merck.com ↗
2012-04-02	GlaxoSmithKline	Shionogi-ViiV Healthcare announces initial data from pivotal phase III study of dolutegravir in HIV gsk.com ↗
2012-01-06	Merck Sharp & Dohme LLC	FDA Approves Merck’s ISENTRESS® (raltegravir) for Use in Children Ages Two Years and Older as Part of HIV-1 Combination Therapy merck.com ↗
2011-10-13	Merck Sharp & Dohme LLC	Merck’s ISENTRESS® (raltegravir) in Combination Therapy Demonstrated Virological and Immunological Efficacy Versus the Efavirenz Regimen at 192 Weeks of Treatment in Previously Untreated Adults with HIV-1 merck.com ↗
2011-09-19	Merck Sharp & Dohme LLC	Merck’s ISENTRESS® (raltegravir) in Combination Therapy Demonstrated Efficacy and Tolerability in an Observational Trial in a Diverse Population of Adults with HIV-1 Regardless of Gender or Race merck.com ↗
2011-07-20	Gilead Sciences	Gilead's Investigational Antiretroviral Elvitegravir Once Daily Non-Inferior to Raltegravir Twice Daily at 48 Weeks gilead.com ↗
2011-03-23	Gilead Sciences	Phase III Clinical Trial of Gilead's Investigational Elvitegravir Meets 48-Week Primary Objective gilead.com ↗

Evidence & citations 21 cited values

Every value below carries the sentence it was read from. 261 sources stand behind the page.

Field	Value	Cited text
Known as	Raltegravir	“Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine,...” NCT00624195 ↗ 243 “Additional ARVs provided for use in this study included fixed dose combination lamivudine/zidovudine (3TC/ZDV), lamivudine (3TC), zidovudine (ZDV), tenofovir (TDF), fixed dose...” NCT00955968 ↗ “ART that concurrently contains combinations of non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as...” NCT05044962 ↗ “The integrase (INI) inhibitors (for example, bictegravir, dolutegravir, elvitegravir/cobicistat, and raltegravir) will be administered in combination with TAF/FTC, as appropriate.” NCT04442737 ↗ “The following agents are allowed as part of the ART regimen: nucleoside reverse transcriptase inhibitors, raltegravir, dolutegravir (DTG), rilpivirine, and maraviroc.” NCT03060447 ↗ “We randomly assigned for 48 weeks 22 patients to continue their current first line regimen of Truvada® plus Kaletra® or intensify it with Maraviroc and Raltegravir.” PMID 25320633 ↗ Oct 2014 “Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs).” NCT03332095 ↗ “28 subjects will change from their normal cART treatment to Raltegravir, which will be given at the standard dose of 400 mg p.o. b.i.d. for 24 months.” NCT02210715 ↗ “Tenofovir+Emtricitabine+Third agent (Including an integrase inhibitor raltegravir or dolutegravir or cobicistat-boosted elvitegravir” NCT02302547 ↗ “change of therapy will include raltegravir which is one of currently recommended medications to treat HIV in Canada.” NCT02691065 ↗ “efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP)” NCT02469246 ↗ Show 233 more sources
Known as	Insentress	“Raltegravir (RAL) 400 mg (Insentress®): twice daily (1 tablet bid), with food” NCT02273765 ↗
Known as	ISENTRESS	“Pilot, Open-label, Randomized, Single-center Study to Asses a Simplification Strategy From Protease Inhibitors to Raltegravir: Once Daily Isentress (ODIS)” NCT00941083 ↗ 19 “Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.” NCT02212379 ↗ “Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers” NCT00772720 ↗ “Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counseling” NCT02247687 ↗ “Multiple Oral Dose Pharmacokinetics of Raltegravir (Isentress®) in Healthy Male and Female Volunteers” NCT02182375 ↗ “Isentress® (Raltegravir 400 mg)1 tablet twice a day + Truvada® (FTC & Tenofovir) 1 tablet” NCT02351908 ↗ “Kaletra (lopinavir/ritonavir 400/100 mg) + Isentress (Raltegravir 400 mg) twice-daily” NCT00752856 ↗ “Raltegravir (RAL) 400 mg (Isentress®): twice daily (1 tablet bid), with food” NCT02273765 ↗ “raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.” NCT01605890 ↗ “Drug: Isentress® (Raltegravir, 400 mg every 12 hours)” NCT01480713 ↗ “or TDF/XTC Gé + Isentress® QD 1200 mg when available” NCT04051970 ↗ Show 9 more sources
Known as	Isentress - Raltegravir	“Isentress - Raltegravir” NCT00809718 ↗ 1 “Isentress (raltegravir)” NCT01902186 ↗
Known as	Isentress hd	ChEMBL registry synonym — accepted as the source's own label CHEMBL254316 ↗
Known as	L-000900612	ChEMBL registry synonym — accepted as the source's own label CHEMBL254316 ↗
Known as	L-000900612 POTASSIUM SALT	ChEMBL registry synonym — accepted as the source's own label CHEMBL254316 ↗
Known as	MK-0518	“Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected,...” NCT02131233 ↗ 13 “Raltegravir (MK-0518) is an HIV-1 integrase inhibitor with potent in vitro activity against HIV-1 strains including those resistant to currently available antiretroviral drugs.” NCT00515827 ↗ “A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)” NCT00293254 ↗ “Raltegravir (MK-0518) 400 mg tablets” NCT02116660 ↗ “Raltegravir (Isentress, MK-0518)” NCT00485264 ↗ “Raltegravir (Isentress/MK-0518)” NCT00781287 ↗ “raltegravir (MK-0518)” NCT00460382 ↗ “Raltegravir, MK-0518” NCT00554398 ↗ “Raltegravir (MK0518)” NCT00520897 ↗ NCT00369941 ↗ NCT00105157 ↗ Show 3 more sources
Known as	MK-0518 POTASSIUM	ChEMBL registry synonym — accepted as the source's own label CHEMBL254316 ↗
Known as	RAL	“Additional ARVs provided for use in this study included fixed dose combination lamivudine/zidovudine (3TC/ZDV), lamivudine (3TC), zidovudine (ZDV), tenofovir (TDF), fixed dose...” NCT00955968 ↗ 31 “To compare changes over 48 weeks in bone mineral density (BMD) between participants randomized to lopinavir/ritonavir (LPV/r) + raltegravir (RAL) or LPV/r + 2-3...” PMID 23921615 ↗ Sep 2013 “The NEAT001/ANRS143 trial demonstrated noninferiority of ritonavir-boosted darunavir combined with either raltegravir (RAL + DRV/r) or tenofovir disoproxil...” PMID 30365452 ↗ Dec 2018 “intensify their therapy with Raltegravir(RAL):1 Protease inhibitor plus 2 nucleoside reverse transcriptase inhibitor plus RAL or 1 non-nucleoside reverse transcriptase...” NCT00773708 ↗ “the objective of this study was to assess the pharmacokinetic (PK) profile in older HIV-infected subjects (>60 years) switching combination antiretroviral therapy (cART) to a...” PMID 25777188 ↗ Jan 2015 “DTG will be replaced by Raltegravir (RAL) 1200 QD, maintaining the other two drugs that constituted the triple therapy established before the inclusion of the patient in the study.” NCT03732625 ↗ “Raltegravir (RAL), the first approved antiretroviral (ARV) in a new class called integrase inhibitors, works by preventing integration of Human Immunodeficiency Virus (HIV).” NCT01173510 ↗ “Participants in Cohort 1 received a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs).” NCT03332095 ↗ “Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.” NCT02212379 ↗ “combination of Raltegravir (RAL) 400mg BID + Atazanavir (ATV) 300 mg BID in Antiretroviral (ARV)-experienced subjects” NCT00814879 ↗ “To assess the safety, tolerability and efficacy of Raltegravir (RAL) when combined with other antiretroviral drugs” NCT01201239 ↗ Show 21 more sources
Known as	Raltegravir (Isentress)	“Raltegravir (Isentress)” NCT01204905 ↗ 1 “raltegravir: Isentress” NCT01318096 ↗
Known as	raltegravir (MK 0518)	“raltegravir (MK 0518)” NCT00614458 ↗
Known as	raltegravir = MK-0518, brand name Isentress	“raltegravir = MK-0518, brand name Isentress” NCT01047995 ↗
Known as	Raltegravir monopotassium salt	ChEMBL registry synonym — accepted as the source's own label CHEMBL254316 ↗
Known as	Raltegravir potassium	“Drug: Raltegravir potassium” NCT01022476 ↗
Known as	Raltegravir potassium component of dutrebis	ChEMBL registry synonym — accepted as the source's own label CHEMBL254316 ↗
Known as	Raltegravir potassium salt	ChEMBL registry synonym — accepted as the source's own label CHEMBL254316 ↗
Known as	RTF	“Raltegravir (RTF) 600 mg two tablets by mouth once per day” NCT03954327 ↗
Action	Inhibit	“Raltegravir is a strong and selective inhibitor of HIV integrase.” NCT00485264 ↗
Modality	Other / unclassified	“Raltegravir is an integrase inhibitor” NCT00870363 ↗
Route	Oral	“MK0518 oral tablets 200 mg b.i.d, for 24 weeks” NCT00105157 ↗