Abacavir

also known as ABC · abacavir sulfate · 1592U89 · abacavir succinate · Abacavir sulphate · ABC: abacavir: Ziagen · Ziagen

Other / unclassified

Developed for: HIV infectious disease · AIDS · lipodystrophy · amyotrophic lateral sclerosis · tuberculosis · HIV wasting syndrome · Aicardi-Goutieres syndrome · AIDS dementia complex
+4 more
· disease related to solid organ transplantation · lactic acidosis · systemic lupus erythematosus · Kaposi's sarcoma
Investigated by: National Institute of Allergy and Infectious Diseases (NIAID) · Glaxo Wellcome · ViiV Healthcare · GlaxoSmithKline · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Gilead Sciences
+84 more
· Germans Trias i Pujol Hospital · ANRS, Emerging Infectious Diseases · Fight AIDS and Infectious Diseases Foundation · Macquarie University, Australia · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Fundacion Clinic per a la Recerca Biomédica · Kirby Institute · National Institute of Mental Health (NIMH) · Pfizer · AMS-PHPT Research Platform (Program for HIV Prevention and Treatment) · Abbott · Assistance Publique - Hôpitaux de Paris · Baylor College of Medicine Children's Foundation · Bayside Health · Burroughs Wellcome · CIHR Canadian HIV Trials Network · Calvary Health Care Bethlehem · Catholic University of the Sacred Heart · Central Institute of Epidemiology, Moscow, Russia · Chulalongkorn University · Columbia University · David Garcia Cinca · Drugs for Neglected Diseases · Duke University · Dupont Applied Biosciences · Epcentre Centre Mbarara Research Centre · European and Developing Countries Clinical Trials Partnership (EDCTP) · French National Institute of Health and Medical Research · Fundacion SEIMC-GESIDA · Harvard School of Public Health (HSPH) · Hoffmann-La Roche · Hospices Civils de Lyon · Hospital de Granollers · Imperial College London · Institut de Sante Publique, d'Epidémiologie et de Développement · Institute of Tropical Medicine, Belgium · International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Jan Gerstoft · Janssen Research & Development, LLC · Joint Clinical Research Centre- Kampala · Kibongoto National Tuberculosis Hospital, Tanzania · Kilimanjaro Christian Medical Centre, Tanzania · King's College London · Makerere University · Mater Misericordiae University Hospital · Merck Sharp & Dohme LLC · Mexican Social Security Institute · Ministry of Foreign Affairs, Luxembourg · Ministry of Health, Rwanda · Mylan Inc. · National Heart, Lung, and Blood Institute (NHLBI) · National Institutes of Health (NIH) · Neuroscience Trials Australia · PENTA Foundation · PHPT/AMS Laboratory, Faculty of Associated Medical Sciences, Chiang Mai University · PPD Development, LP · Pharmaceutical Product Development, (PPD) LLC · Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire · Public Research Centre Health, Luxembourg · Queen Fabiola Children's University Hospital · Radboud University Medical Center · SEARCH Research Foundation · Shionogi · St Stephens Aids Trust · St Vincent's Hospital, Sydney · TRICALS Foundation · The HIV Netherlands Australia Thailand Research Collaboration · The University of New South Wales · Triangle Pharmaceuticals · Trimeris · UNITAID · URC-CIC Paris Descartes Necker Cochin · University College Dublin · University of Bordeaux · all 90 on the full record

Regulatory milestones approvals, filings & regulatory actions · 9 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed HIV infectious disease 2 milestones
Filed	US (FDA)	—	HIV infectious disease	2021-10-04	“regulatory submission to the U.S. Food and Drug Administration (FDA) for approval of a new dispersible tablet formulation of the fixed dose combination of abacavir” viivhealthcare.com ↗
Filed	US (FDA)	—	HIV infectious disease	2013-10-22	“ViiV Healthcare today announced the submission of a regulatory application in the United States for its investigational single-tablet regimen (STR) combining dolutegravir,...” gsk.com ↗
Approved Indication not stated 3 milestones
Label expansions (5)	US (FDA)	ZIAGEN	—	2000-12-15 – 2015-03-23	fda.gov ↗
Approved	EU (EMA)	Ziagen	—	1999-07-08	europa.eu ↗
Approved	US (FDA)	ZIAGEN	—	1998-12-17	fda.gov ↗

Trials 115 · started per year

today

US approved 1998

EU approved 1999

1994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT05030025	Aug 2021	HIV infectious disease	Mylan Inc.	Completed	No outcome recorded
Phase 113 trials
Phase 1	NCT04827134	May → Jul 2021	HIV infectious disease	ViiV Healthcare	Completed	No outcome recorded
Phase 1	NCT03441984	Feb → Apr 2018	HIV infectious disease	ViiV Healthcare	Completed	No outcome recorded
Phase 1	NCT02539576	Oct → Nov 2015	HIV infectious disease	ViiV Healthcare	Completed	No outcome recorded
Phase 1	NCT01366547	Jun → Jul 2011	HIV infectious disease	ViiV Healthcare	Completed	No outcome recorded
Phase 1	NCT01220232	Nov 2010 → Jan 2011	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT00320307	Sep 2005 → ?	HIV infectious disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00001968	Jan → Nov 2000	AIDS	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00002141	Jul 1994 → ?	HIV infectious disease	Burroughs Wellcome	Completed	No outcome recorded
Phase 1	NCT00000864	? → Jan 2001	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00002183	—	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
Phase 1	NCT00002388	—	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
Phase 1	NCT00011479	? → Aug 2002	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00002198	—	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded

Phase 1/22 trials
Phase 1/2	NCT03760458	Sep 2020 → Dec 2021	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1/2	NCT03836833	Jun → Nov 2019	HIV infectious disease	Drugs for Neglected Diseases	Unknown	No outcome recorded
Phase 224 trials · 1 missed
Phase 2	NCT06356740	Sep 2024 → Nov 2028 expected	systemic lupus erythematosus	Hospices Civils de Lyon	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	NCT02868580	Oct 2016 → Dec 2017	amyotrophic lateral sclerosis	Neuroscience Trials Australia	Completed	No outcome recorded
Phase 2	NCT02363452	Sep 2015 → Jan 2018	Aicardi-Goutieres syndrome	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 2	NCT00958100	Aug 2009 → Nov 2010	AIDS	Catholic University of the Sacred Heart	Completed	No outcome recorded
Phase 2	NCT00820118	May 2009 → May 2012	HIV infectious disease	ANRS, Emerging Infectious Diseases	Completed	No outcome recorded
Phase 2	NCT00270296	Jun 2006 → Mar 2009	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00270556	Jan 2003 → Oct 2004	HIV infectious disease	Gilead Sciences	Completed	No outcome recorded
Phase 2	NCT00001132	Nov 1999 → Apr 2001	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000940	May 1999 → Oct 2006	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00002239	May 1999 → ?	HIV infectious disease	Hoffmann-La Roche	Completed	No outcome recorded
Phase 2	NCT00001758	Nov 1997 → Aug 2003	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000885	? → Jun 2003	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Missed primary
Phase 2	NCT00102206	? → May 2007	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00002419	—	HIV infectious disease	Gilead Sciences	Completed	No outcome recorded
Phase 2	NCT00002390	—	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
Phase 2	NCT00002213	—	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
Phase 2	NCT00002233	—	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
Phase 2	NCT00021463	? → Feb 2002	HIV infectious disease, lipodystrophy	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00001086	? → Sep 1999	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000872	? → Jan 2005	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00002364	—	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
Phase 2	NCT00002440	—	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
Phase 2	NCT00006152	? → Aug 2002	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded

Phase 2/35 trials · 3 missed
Phase 2/3	NCT01656122	Jul 2012 → Jul 2015	HIV infectious disease	The HIV Netherlands Australia Thailand Research Collaboration	Completed	No outcome recorded
Phase 2/3	NCT01127204	Jun 2011 → Apr 2015	HIV infectious disease	ANRS, Emerging Infectious Diseases	Completed	Missed primary
Phase 2/3	NCT00624195	Mar 2007 → Feb 2012	HIV infectious disease	University of California, San Diego	Completed	Missed primary
Phase 2/3	NCT00039741	Aug 2002 → Aug 2009	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Missed primary
Phase 2/3	NCT00143702	Aug 2001 → Aug 2006	lactic acidosis	University of British Columbia	Completed	No outcome recorded
Phase 329 trials · 5 met primary · 2 missed
Phase 3	NCT06658977	Nov 2024 → Jun 2025	amyotrophic lateral sclerosis	Macquarie University, Australia	Terminated	No outcome recorded
Phase 3	NCT05193994	Feb 2022 → Jun 2025	amyotrophic lateral sclerosis	Macquarie University, Australia	Terminated	No outcome recorded
Phase 3	NCT02588820	Apr 2016 → Nov 2018	HIV infectious disease	David Garcia Cinca	Unknown	No outcome recorded
Phase 3	NCT02075593	Dec 2014 → Oct 2018	HIV infectious disease, arthropathy	ViiV Healthcare	Completed	No outcome recorded
Phase 3	NCT02105987	Apr 2014 → Apr 2015	HIV infectious disease	ViiV Healthcare	Completed	Met primary
Phase 3	NCT01910402	Aug 2013 → Sep 2015	HIV infectious disease	ViiV Healthcare	Completed	Met primary
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	NCT01440569	Sep 2011 → Aug 2012	AIDS	Gilead Sciences	Completed	No outcome recorded
Phase 3	NCT01146873	Jul 2010 → Dec 2014	AIDS	Columbia University	Completed	Met primary
Phase 3	NCT01153217	Jul 2010 → Jun 2012	HIV infectious disease	Germans Trias i Pujol Hospital	Completed	No outcome recorded
Phase 3	NCT00796263	May 2009 → Jun 2033 expected	HIV infectious disease	SEARCH Research Foundation	Recruiting	No outcome recorded
Phase 3	NCT00118898	Sep 2005 → Nov 2009	HIV infectious disease	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	Completed	No outcome recorded
Phase 3	NCT00102960	Jul 2005 → Sep 2012	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Met primary
Phase 3	NCT00338390	Apr 2005 → Feb 2007	HIV infectious disease	Hospital de Granollers	Completed	No outcome recorded
Phase 3	NCT00314626	Nov 2004 → Feb 2007	HIV infectious disease	Germans Trias i Pujol Hospital	Completed	No outcome recorded
Phase 3	NCT00078247	Oct 2004 → ?	HIV infectious disease, tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Missed primary
Phase 3	NCT00086359	Jul 2004 → Sep 2007	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 3	NCT00094367	Jul 2004 → Oct 2005	HIV infectious disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00053638	Feb 2003 → Oct 2004	HIV infectious disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00046176	Aug 2002 → May 2004	HIV infectious disease	ViiV Healthcare	Completed	No outcome recorded
Phase 3	NCT00044577	Jul 2002 → May 2004	HIV infectious disease	ViiV Healthcare	Completed	No outcome recorded
Phase 3	NCT00002362	Aug 1999 → ?	HIV infectious disease	Triangle Pharmaceuticals	Suspended	No outcome recorded
Phase 3	NCT00002245	Apr 1999 → ?	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
Phase 3	NCT00013520	? → Jun 2005	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Missed primary
Phase 3	NCT00002163	—	AIDS dementia complex, HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
Phase 3	NCT00006154	—	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 3	NCT00002199	—	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
Phase 3	NCT00002389	—	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
Phase 3	NCT00002391	—	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded

Phase 427 trials · 5 met primary · 1 missed
Phase 4	NCT06337032	Aug 2024 → Mar 2034 expected	HIV infectious disease	Gilead Sciences	Recruiting	No outcome recorded
Phase 4	NCT06602622	Aug 2024 → Nov 2025 overdue	HIV wasting syndrome	Mexican Social Security Institute	Recruiting	No outcome recorded
Phase 4	NCT03360682	Apr 2018 → May 2020	HIV infectious disease, disease related to solid organ transplantation	Fundacion Clinic per a la Recerca Biomédica	Completed	No outcome recorded
Phase 4	NCT02659761	Nov 2016 → Sep 2021	HIV infectious disease	University College Dublin	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT02509195	Aug 2015 → Feb 2017	HIV infectious disease	St Stephens Aids Trust	Completed	No outcome recorded
Phase 4	NCT02246998	Dec 2014 → Jan 2016	HIV infectious disease	Gilead Sciences	Completed	No outcome recorded
Phase 4	NCT02093585	Jan 2014 → Apr 2016	HIV infectious disease	Jan Gerstoft	Completed	No outcome recorded
Phase 4	NCT01886638	Aug 2013 → Jun 2014	HIV infectious disease, cardiovascular disorder	Bayside Health	Completed	No outcome recorded
Phase 4	NCT01367236	Jan 2013 → Oct 2015	HIV infectious disease, cognitive disorder	Imperial College London	Completed	Missed primary
Phase 4	NCT01059422	Oct 2010 → Mar 2013	HIV infectious disease, tuberculosis	Central Institute of Epidemiology, Moscow, Russia	Completed	No outcome recorded
Phase 4	NCT01102972	Apr 2010 → Jun 2012	HIV infectious disease	ViiV Healthcare	Completed	Met primary
Phase 4	NCT00865475	Dec 2008 → Mar 2013	HIV infectious disease	Fundacion SEIMC-GESIDA	Completed	No outcome recorded
Phase 4	NCT00335322	Feb 2007 → Mar 2011	HIV infectious disease	Kirby Institute	Completed	Met primary
Phase 4	NCT00337922	Jul 2006 → ?	HIV infectious disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00340080	Apr 2006 → ?	HIV infectious disease	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT00356616	Sep 2005 → Jun 2007	HIV infectious disease	Germans Trias i Pujol Hospital	Terminated	No outcome recorded
Phase 4	NCT00244712	Jul 2005 → Apr 2008	HIV infectious disease	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT00335192	Jan → Sep 2005	HIV infectious disease	Germans Trias i Pujol Hospital	Completed	No outcome recorded
Phase 4	NCT00851630	Jun 2004 → Sep 2007	HIV infectious disease, tuberculosis	Duke University	Completed	No outcome recorded
Phase 4	NCT00082394	Apr 2004 → Mar 2006	HIV infectious disease	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT00192660	Feb 2003 → Oct 2006	cardiovascular disorder, lipodystrophy	Kirby Institute	Completed	No outcome recorded
Phase 4	NCT00038506	Mar 2002 → Aug 2004	HIV infectious disease	ViiV Healthcare	Completed	No outcome recorded
Phase 4	NCT00011895	Feb 2001 → ?	HIV infectious disease	GlaxoSmithKline	Unknown	No outcome recorded
Phase 4	NCT00005764	May 2000 → ?	HIV infectious disease, lipodystrophy	Glaxo Wellcome	Completed	No outcome recorded
Phase 4	NCT00004585	Oct 1999 → ?	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
Phase 4	NCT00005106	Sep 1999 → ?	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
Phase 4	NCT00005018	Jul 1999 → Oct 2000	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded

Phase not applicable14 trials · 1 missed
—	NCT02384395	Sep 2015 → Mar 2020	HIV infectious disease	University of North Carolina, Chapel Hill	Completed	No outcome recorded
—	NCT00087945	Jul → Dec 2004	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
—	NCT00028314	Mar 2002 → Mar 2005	HIV wasting syndrome, lipodystrophy	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
—	NCT00001119	Oct 1999 → Jun 2004	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
—	NCT00002217	—	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
—	NCT00002200	—	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
—	NCT00002197	—	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
—	NCT00000919	? → Nov 2002	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
—	NCT00006578	—	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Withdrawn	No outcome recorded
—	NCT00000922	? → Jan 2003	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Missed primary
—	NCT00002216	—	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
—	NCT00004855	? → Apr 2005	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
—	NCT00006617	? → Jun 2007	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
—	NCT00002205	—	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded

Comparator or background therapy68 trials
Phase 1	NCT06428045 Background	Apr 2025 → Apr 2029 expected	malignant glioma	University of Miami	Recruiting	No outcome recorded
Phase 1	NCT02556268 Background	Feb → Dec 2016	—	Bayer	Completed	No outcome recorded
Phase 1	NCT01052701 Comparator	Dec 2009 → Sep 2012	HIV infectious disease, hepatitis C virus infection	Johns Hopkins University	Completed	No outcome recorded
Phase 1	NCT00765271 Comparator	May → Oct 2008	HIV infectious disease	St Stephens Aids Trust	Completed	No outcome recorded
Phase 1	NCT01982396 Comparator	Jan 2003 → Feb 2004	HIV infectious disease	PENTA Foundation	Completed	No outcome recorded
Phase 1	NCT02182765 Comparator	Apr 1999 → Jul 2001	HIV infectious disease	Boehringer Ingelheim	Terminated	No outcome recorded
Phase 1	NCT00001766 Background	Aug 1998 → Aug 2003	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00000865 Background	? → Apr 1998	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	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	NCT04731103 Comparator	Aug 2022 → Mar 2024	Aicardi-Goutieres syndrome	University of Edinburgh	Completed	No outcome recorded
Phase 2	NCT04012931 Background	Jul 2019 → Feb 2023	HIV infectious disease	Janssen Research & Development, LLC	Completed	No outcome recorded
Phase 2	NCT02120352 Comparator	Apr 2014 → Aug 2015	HIV infectious disease	ViiV Healthcare	Completed	No outcome recorded
Phase 2	NCT01641809 Background	Aug 2012 → Oct 2013	HIV infectious disease	ViiV Healthcare	Completed	No outcome recorded
Phase 2	NCT00799864 Background	Jan 2011 → Aug 2022	—	Janssen Sciences Ireland UC	Completed	No outcome recorded
Phase 2	NCT00915655 Background	Jul 2009 → Sep 2010	HIV infectious disease	Tibotec Pharmaceuticals, Ireland	Completed	No outcome recorded
Phase 2	NCT00214890 Comparator	Dec 2004 → Jun 2008	HIV infectious disease	University of California, San Diego	Completed	No outcome recorded
Phase 2	NCT00084149 Background	Feb 2004 → Jan 2008	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00647946 Comparator	Feb 2003 → Oct 2004	lipodystrophy	Gilead Sciences	Completed	No outcome recorded
Phase 2	NCT00002423 Background	Mar 1999 → ?	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
Phase 2	NCT00000912 Background	? → May 2000	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00021489 Background	—	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Withdrawn	No outcome recorded
Phase 2	NCT00031070 Background	? → Dec 2006	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2/3	NCT02016924 Background	Jan 2014 → Jun 2025 overdue	AIDS	Gilead Sciences	Active not recruiting	No outcome recorded
Phase 2/3	NCT00834457 Comparator	Jun 2007 → Jul 2009	Kaposi's sarcoma	Parirenyatwa Hospital	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	NCT04155554 Comparator	Jan → Aug 2020	HIV infectious disease	University Hospital of Siena	Unknown	No outcome recorded
Phase 3	NCT03631732 Comparator	Aug 2018 → Aug 2019	HIV infectious disease	Gilead Sciences	Completed	Met primary
Phase 3	NCT03256422 Background	Sep 2017 → Aug 2019	HIV infectious disease	ANRS, Emerging Infectious Diseases	Completed	No outcome recorded
Phase 3	NCT02938520 Comparator	Oct 2016 → Aug 2018 overdue	HIV infectious disease	ViiV Healthcare	Active not recruiting	Met primary
Phase 3	NCT02596334 Comparator	Dec 2015 → Jun 2017	HIV infectious disease	Centre Hospitalier Régional d'Orléans	Terminated	No outcome recorded
Phase 3	NCT02603107 Background	Nov 2015 → May 2017	HIV infectious disease	Gilead Sciences	Completed	Met primary
Phase 3	NCT02469246 Comparator	Jun 2015 → Dec 2017	HIV infectious disease	Gilead Sciences	Completed	Met primary
Phase 3	NCT02275780 Background	Dec 2014 → Sep 2016	—	Merck Sharp & Dohme LLC	Completed	Met primary
Phase 3	NCT02157311 Background	Jul 2014 → Jan 2016	HIV infectious disease	ANRS, Emerging Infectious Diseases	Completed	No outcome recorded
Phase 3	NCT01605084 Background	Jun 2012 → Aug 2014	HIV infectious disease	Bristol-Myers Squibb	Withdrawn	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	NCT00928187 Comparator	Nov 2009 → Sep 2013	HIV infectious disease	ANRS, Emerging Infectious Diseases	Completed	No outcome recorded
Phase 3	NCT00978068 Comparator	Sep 2009 → Jan 2013	HIV infectious disease, malaria	University of California, San Francisco	Completed	No outcome recorded
Phase 3	NCT00727597 Background	Jul 2008 → Aug 2010	HIV infectious disease	Georgetown University	Completed	No outcome recorded
Phase 3	NCT00708162 Background	Jul 2008 → Dec 2010	HIV infectious disease	Gilead Sciences	Completed	Met primary
Phase 3	NCT00427297 Background	Sep 2007 → May 2009	HIV infectious disease	University of Washington	Terminated	No outcome recorded
Phase 3	NCT00440947 Background	Mar 2007 → Jul 2010	HIV infectious disease	ViiV Healthcare	Completed	Met primary
Phase 3	NCT00234091 Comparator	Apr 2006 → Sep 2011	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 3	NCT00085943 Background	May 2004 → ?	HIV infectious disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT00318123 Background	Apr 2004 → Apr 2007	HIV infectious disease	Germans Trias i Pujol Hospital	Completed	No outcome recorded
Phase 3	NCT00405925 Comparator	Mar 2003 → Aug 2009	HIV infectious disease	Rijnstate Hospital	Completed	No outcome recorded
Phase 3	NCT00009061 Background	Nov 2000 → ?	HIV infectious disease	Glaxo Wellcome	Unknown	No outcome recorded
Phase 3	NCT00008554 Background	Nov 2000 → ?	HIV infectious disease	Glaxo Wellcome	Unknown	No outcome recorded
Phase 3	NCT00004981 Background	—	HIV infectious disease	Glaxo Wellcome	Unknown	No outcome recorded
Phase 3	NCT00002409 Background	—	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
Phase 4	NCT07138144 Comparator	Jul 2025 → Feb 2026 overdue	HIV infectious disease	José Antonio Mata Marín	Recruiting	No outcome recorded
Phase 4	NCT03447873 Comparator	Jun 2017 → Sep 2020	HIV infectious disease	Hospitales Universitarios Virgen del Rocío	Completed	No outcome recorded
Phase 4	NCT02957864 Comparator	Oct 2016 → Jun 2020	HIV infectious disease, chronic kidney disease, poisoning	Erasmus Medical Center	Unknown	No outcome recorded
Phase 4	NCT02159599 Comparator	Jul 2014 → Apr 2016	HIV infectious disease	Fundacion SEIMC-GESIDA	Completed	Met primary
Phase 4	NCT01637259 Comparator	Jun 2012 → Dec 2015	HIV infectious disease, proteinuria	Kirby Institute	Completed	No outcome recorded
Phase 4	NCT00865007 Comparator	Dec 2008 → Jun 2012	HIV infectious disease, lipodystrophy	Fundacion SEIMC-GESIDA	Completed	No outcome recorded
Phase 4	NCT00772902 Comparator	Oct 2008 → Sep 2009	—	Gilead Sciences	Completed	No outcome recorded
Phase 4	NCT00724711 Comparator	Jul 2008 → Mar 2011	HIV infectious disease	Gilead Sciences	Completed	Met primary
Phase 4	NCT00647244 Comparator	Jun 2008 → Aug 2010	HIV infectious disease	Aarhus University Hospital	Completed	No outcome recorded
Phase 4	NCT00544128 Comparator	Oct 2007 → Feb 2012	HIV infectious disease	International Medical Center of Japan	Completed	No outcome recorded
Phase 4	NCT02028676 Comparator	Mar 2007 → Mar 2012	HIV infectious disease	Medical Research Council	Completed	No outcome recorded
Phase 4	NCT00335270 Background	Mar 2006 → Dec 2007	HIV infectious disease	Duke University	Completed	No outcome recorded
Phase 4	NCT00192634 Comparator	Dec 2005 → Aug 2008	HIV infectious disease	Kirby Institute	Completed	No outcome recorded
Phase 4	NCT00386659 Background	—	HIV infectious disease	Hospital Clinic of Barcelona	Terminated	No outcome recorded
Phase 4	NCT00005017 Background	—	HIV infectious disease	Glaxo Wellcome	Unknown	No outcome recorded
—	NCT00428116 Comparator	Sep 2007 → Jul 2013	HIV infectious disease	University of Washington	Terminated	No outcome recorded
—	NCT00051090 Background	—	HIV infectious disease, hepatitis B virus infection	National Institute of Allergy and Infectious Diseases (NIAID)	Withdrawn	No outcome recorded

News releases announcing trial results or a regulatory action · 26

Date	Issuer	Release
2023-09-05	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Regulatory Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC), a Once-daily Treatment for Children Living with HIV viatris.com ↗ The FDA's tentative approval through the President's Emergency Plan for AIDS Relief (PEPFAR) program means the formulation meets all the agency's quality, safety, and efficacy standards.
2022-06-14	Drugs for Neglected Diseases	Regulatory Cipla and DNDi launch child-friendly 4-in-1 antiretroviral treatment for young children living with HIV in South Africa dndi.org ↗ The South African Health Products Regulatory Authority (SAHPRA) has approved a sweet-tasting, heat-stable, ‘4-in-1’ fixed-dose combination of four antiretroviral (ARV) treatments composed of abacavir, lamivudine, lopinavir, and ritonavir that is specifically designed for infants and young children with HIV.
2022-03-30	GlaxoSmithKline	Regulatory ViiV Healthcare announces US FDA approval of Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV gsk.com ↗
2022-03-30	ViiV Healthcare	Regulatory ViiV HEALTHCARE ANNOUNCES US FDA APPROVAL OF TRIUMEQ PD, THE FIRST DISPERSIBLE SINGLE TABLET REGIMEN CONTAINING DOLUTEGRAVIR, A ONCE-DAILY TREATMENT FOR CHILDREN LIVING WITH HIV viivhealthcare.com ↗
2021-10-04	GlaxoSmithKline	Regulatory ViiV Healthcare submits FDA application for first dispersible single tablet regimen containing dolutegravir (DTG) for children living with HIV gsk.com ↗
2021-10-04	ViiV Healthcare	Regulatory ViiV Healthcare submits FDA application for first dispersible single tablet regimen containing dolutegravir (DTG) for children living with HIV viivhealthcare.com ↗
2020-10-21	Gilead Sciences	Results Gilead Announces New Data on Biktarvy® for the Treatment of HIV in Black Americans gilead.com ↗ After one year, those who switched from TDF to TAF (n=828) and those who switched from abacavir (ABC) to TAF (n=142) experienced a mean unadjusted weight gain of 1.4 kg and 0.2 kg, respectively (p=0.039).
2020-03-11	Janssen Research & Development, LLC	Results Janssen Announces Results of Phase 3 Study Demonstrating the Safety and Efficacy of Long-Acting Injectable HIV Treatment Regimen of Rilpivirine And Cabotegravir through 96 Weeks jnj.com ↗ The study – First Long-Acting Injectable Regimen (FLAIR) trial – demonstrated positive 96-week results in long-term safety and efficacy of rilpivirine and cabotegravir.
2019-11-06	Gilead Sciences	Results Gilead’s Biktarvy Maintained High Efficacy With No Cases of Treatment-Emergent Resistance Through Three Years in Phase 3 HIV Clinical Trials gilead.com ↗ Across all treatment groups no participants developed treatment failure with treatment-emergent resistance.
2019-03-07	GlaxoSmithKline	Results ViiV Healthcare presents positive, 48-week data from two pivotal phase III studies showing long-acting, injectable two-drug regimen of cabotegravir and rilpivirine has similar efficacy to daily, three-drug oral treatment in adults living with HIV-1 infection gsk.com ↗ The study found virologic suppression rates (HIV-1 RNA <50 c/mL) at Week 48 were similar between treatment arms (cabotegravir + rilpivirine: 265/283 [93.6%], Triumeq: 264/283 [93.3%], adjusted difference: 0.4%. 95% CI: -3.7, 4.5).
2019-03-07	ViiV Healthcare	Results ViiV HEALTHCARE PRESENTS POSITIVE, 48-WEEK DATA FROM TWO PIVOTAL PHASE III STUDIES SHOWING LONG-ACTING, INJECTABLE TWO-DRUG REGIMEN OF CABOTEGRAVIR AND RILPIVIRINE HAS SIMILAR EFFICACY TO DAILY, THREE-DRUG ORAL TREATMENT IN ADULTS LIVING WITH HIV-1 INFECTION viivhealthcare.com ↗ The study found virologic suppression rates (HIV-1 RNA <50 c/mL) at Week 48 were similar between treatment arms (cabotegravir + rilpivirine: 265/283 [93.6%], Triumeq: 264/283 [93.3%], adjusted difference: 0.4%. 95% CI: -3.7, 4.5).
2018-10-30	GlaxoSmithKline	Results ViiV Healthcare reports positive 48-week results for second phase III study for novel, long-acting, injectable HIV-treatment regimen gsk.com ↗ The study showed long-acting cabotegravir and rilpivirine, injected once a month, had similar efficacy to Triumeq at Week 48 based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre [c/mL] using the FDA Snapshot algorithm.
2018-10-03	Gilead Sciences	Results Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy gilead.com ↗ In the ongoing study, Biktarvy was found to be statistically non-inferior to a regimen of abacavir/dolutegravir/lamivudine (600/50/300mg, ABC /DTG/3TC) through 96 weeks of therapy.
2018-03-05	Gilead Sciences	Results Gilead Presents Results from Phase 3 Study Evaluating Patients Who Switched to Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) from Regimen Containing Abacavir, Dolutegravir and Lamivudine gilead.com ↗ Through Week 48, Biktarvy was found to be statistically non-inferior to ABC /DTG/3TC with a numerically lower incidence of mild or moderate study drug-related adverse events and no treatment-emergent resistance.
2017-10-04	Gilead Sciences	Results Gilead Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide From Boosted Protease Inhibitor-Based Regimens gilead.com ↗ In the ongoing study, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing bPIs and demonstrated no treatment-emergent resistance at 48 weeks.
2017-07-24	Gilead Sciences	Results Gilead Announces Phase 3 Results for Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV gilead.com ↗ At Week 48, 92.4 percent (n=290/314) of patients taking BIC/FTC/TAF and 93.0 percent (n=293/315) of patients taking ABC /DTG/3TC achieved the primary endpoint
2016-07-18	GlaxoSmithKline	Results ARIA study shows superior efficacy of Triumeq® for treatment-naïve women living with HIV gsk.com ↗ ViiV Healthcare today presented 48-week data from the phase IIIb, open-label, international, multi-centre ARIA study which showed superior efficacy for Triumeq® (dolutegravir/abacavir/lamivudine) compared with atazanavir boosted with ritonavir (ATV/r) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 495 treatment-naïve women living with HIV.
2015-09-23	GlaxoSmithKline	Results New Phase IIIb/IV data show switching to once-daily Triumeq® maintains HIV viral suppression gsk.com ↗ Furthermore, statistically, the treatment satisfaction score improved significantly more for those patients switching to once-daily abacavir/dolutegravir/lamivudine from their established regimen, as assessed by the HIV Treatment Satisfaction Questionnaire (adjusted difference 2.4, 95% CI: 1.3, 3.5; p<0.001).
2014-09-03	GlaxoSmithKline	Regulatory ViiV Healthcare receives EU marketing authorisation for Triumeq® (dolutegravir/abacavir/lamivudine), a new once-daily single-pill regimen for the treatment of HIV gsk.com ↗ We are delighted with today’s approval that offers people living with HIV in Europe the first single-pill regimen containing dolutegravir.
2014-08-22	GlaxoSmithKline	Regulatory ViiV Healthcare receives FDA approval for Triumeq® (abacavir, dolutegravir and lamivudine), a new single-pill regimen for the treatment of HIV-1 infection gsk.com ↗ ViiV Healthcare announced today that the US Food and Drug Administration (FDA) has approved Triumeq® (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection.
2014-06-27	GlaxoSmithKline	Regulatory Triumeq® (dolutegravir/abacavir/lamivudine) single-tablet regimen receives positive CHMP opinion in Europe for the treatment of HIV gsk.com ↗ the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Triumeq® (dolutegravir/abacavir/lamivudine)
2013-10-25	GlaxoSmithKline	Regulatory ViiV Healthcare announces European regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV gsk.com ↗ ViiV Healthcare today announced the submission of a regulatory application in Europe for its investigational single-tablet regimen (STR) combining dolutegravir (DTG), abacavir (ABC) and lamivudine (3TC) for the treatment of people living with HIV.
2013-10-22	GlaxoSmithKline	Regulatory ViiV Healthcare announces US regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV gsk.com ↗ ViiV Healthcare today announced the submission of a regulatory application in the United States for its investigational single-tablet regimen (STR) combining dolutegravir, abacavir and lamivudine for the treatment of people living with HIV-1.
2005-02-28	Gilead Sciences	Results 48-Week Data Comparing Viread Versus Abacavir as Replacement for Thymidine Analogue in Lipoatraphic HIV Patients Presented at the 12th Conference on Retroviruses and Opportunistic Infections gilead.com ↗ Gilead Sciences (Nasdaq:GILD) today announced the presentation of preliminary 48-week data from the RAVE (Randomized Abacavir Viread Evaluation) study at the 12th Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.
2003-07-14	Gilead Sciences	Results Phase III Trial of Emtriva, New Once-Daily Capsule for HIV, Shows Continued Response Through 60 Weeks gilead.com ↗ At 24 weeks, Emtriva showed comparable efficacy to abacavir, with 83 percent of patients taking Emtriva (n=18) experiencing a reduction in HIV RNA to under 50 copies/mL, compared with 63 percent of patients receiving abacavir (n=19).
1998-09-23	Gilead Sciences	Results Gilead Sciences Provides Update on PREVEON® Clinical Program for the Treatment of HIV gilead.com ↗ These data suggest that treatment with PREVEON, abacavir and efavirenz, a regimen that does not contain a protease inhibitor, resulted in viral load reductions in patients who have failed treatment with other antiretrovirals.

All press releases naming this drug 26 releases

Date	Issuer	Release
2023-09-05	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC), a Once-daily Treatment for Children Living with HIV viatris.com ↗
2022-06-14	Drugs for Neglected Diseases	Cipla and DNDi launch child-friendly 4-in-1 antiretroviral treatment for young children living with HIV in South Africa dndi.org ↗
2022-03-30	GlaxoSmithKline	ViiV Healthcare announces US FDA approval of Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV gsk.com ↗
2022-03-30	ViiV Healthcare	ViiV HEALTHCARE ANNOUNCES US FDA APPROVAL OF TRIUMEQ PD, THE FIRST DISPERSIBLE SINGLE TABLET REGIMEN CONTAINING DOLUTEGRAVIR, A ONCE-DAILY TREATMENT FOR CHILDREN LIVING WITH HIV viivhealthcare.com ↗
2021-10-04	GlaxoSmithKline	ViiV Healthcare submits FDA application for first dispersible single tablet regimen containing dolutegravir (DTG) for children living with HIV gsk.com ↗
2021-10-04	ViiV Healthcare	ViiV Healthcare submits FDA application for first dispersible single tablet regimen containing dolutegravir (DTG) for children living with HIV viivhealthcare.com ↗
2020-10-21	Gilead Sciences	Gilead Announces New Data on Biktarvy® for the Treatment of HIV in Black Americans gilead.com ↗
2020-03-11	Janssen Research & Development, LLC	Janssen Announces Results of Phase 3 Study Demonstrating the Safety and Efficacy of Long-Acting Injectable HIV Treatment Regimen of Rilpivirine And Cabotegravir through 96 Weeks jnj.com ↗
2019-11-06	Gilead Sciences	Gilead’s Biktarvy Maintained High Efficacy With No Cases of Treatment-Emergent Resistance Through Three Years in Phase 3 HIV Clinical Trials gilead.com ↗
2019-03-07	GlaxoSmithKline	ViiV Healthcare presents positive, 48-week data from two pivotal phase III studies showing long-acting, injectable two-drug regimen of cabotegravir and rilpivirine has similar efficacy to daily, three-drug oral treatment in adults living with HIV-1 infection gsk.com ↗
2019-03-07	ViiV Healthcare	ViiV HEALTHCARE PRESENTS POSITIVE, 48-WEEK DATA FROM TWO PIVOTAL PHASE III STUDIES SHOWING LONG-ACTING, INJECTABLE TWO-DRUG REGIMEN OF CABOTEGRAVIR AND RILPIVIRINE HAS SIMILAR EFFICACY TO DAILY, THREE-DRUG ORAL TREATMENT IN ADULTS LIVING WITH HIV-1 INFECTION viivhealthcare.com ↗
2018-10-30	GlaxoSmithKline	ViiV Healthcare reports positive 48-week results for second phase III study for novel, long-acting, injectable HIV-treatment regimen gsk.com ↗
2018-10-03	Gilead Sciences	Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy gilead.com ↗
2018-03-05	Gilead Sciences	Gilead Presents Results from Phase 3 Study Evaluating Patients Who Switched to Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) from Regimen Containing Abacavir, Dolutegravir and Lamivudine gilead.com ↗
2017-10-04	Gilead Sciences	Gilead Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide From Boosted Protease Inhibitor-Based Regimens gilead.com ↗
2017-07-24	Gilead Sciences	Gilead Announces Phase 3 Results for Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV gilead.com ↗
2016-07-18	GlaxoSmithKline	ARIA study shows superior efficacy of Triumeq® for treatment-naïve women living with HIV gsk.com ↗
2015-09-23	GlaxoSmithKline	New Phase IIIb/IV data show switching to once-daily Triumeq® maintains HIV viral suppression gsk.com ↗
2014-09-03	GlaxoSmithKline	ViiV Healthcare receives EU marketing authorisation for Triumeq® (dolutegravir/abacavir/lamivudine), a new once-daily single-pill regimen for the treatment of HIV gsk.com ↗
2014-08-22	GlaxoSmithKline	ViiV Healthcare receives FDA approval for Triumeq® (abacavir, dolutegravir and lamivudine), a new single-pill regimen for the treatment of HIV-1 infection gsk.com ↗
2014-06-27	GlaxoSmithKline	Triumeq® (dolutegravir/abacavir/lamivudine) single-tablet regimen receives positive CHMP opinion in Europe for the treatment of HIV gsk.com ↗
2013-10-25	GlaxoSmithKline	ViiV Healthcare announces European regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV gsk.com ↗
2013-10-22	GlaxoSmithKline	ViiV Healthcare announces US regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV gsk.com ↗
2005-02-28	Gilead Sciences	48-Week Data Comparing Viread Versus Abacavir as Replacement for Thymidine Analogue in Lipoatraphic HIV Patients Presented at the 12th Conference on Retroviruses and Opportunistic Infections gilead.com ↗
2003-07-14	Gilead Sciences	Phase III Trial of Emtriva, New Once-Daily Capsule for HIV, Shows Continued Response Through 60 Weeks gilead.com ↗
1998-09-23	Gilead Sciences	Gilead Sciences Provides Update on PREVEON® Clinical Program for the Treatment of HIV gilead.com ↗

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 193 sources stand behind the page.

Field	Value	Cited text
Known as	abacavir	“Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine,...” NCT00624195 ↗ 176 “This study will compare the ability of fosamprenavir 700 mg with ritonavir 100 mg twice a day or lopinavir 400 mg with ritonavir 100 mg twice a day both combined with a fixed...” NCT00085943 ↗ “Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC,...” NCT01363011 ↗ “Antiretroviral therapy, administered orally may include regimens such as: bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir...” NCT05729568 ↗ “Second generation integrase inhibitor 1) Bictegravir 50 mg/ alafenamide tenofovir 25 mg/ emtricitabine 200 mg (BIC/TAF/FTC); 2) Dolutegravir 50 mg/ abacavir 600 mg/ lamivudine...” NCT06602622 ↗ “NRTIs included abacavir, emtricitabine, Combivir (lamivudine/zidovudine, coformulated), Epzicom (abacavir/lamivudine, coformulated), lamivudine, stavudine, tenofovir DF,...” NCT01252940 ↗ “Bictegravir 50 mg / tenofovir alafenamide 25 mg / emtricitabine 200 mg or dolutegravir 50 mg / lamivudine 300 mg / abacavir 600 mg, both combinations in a single tablet, will...” NCT07138144 ↗ “adult FDC of abacavir/dolutegravir/lamivudine and adult FDC of dolutegravir/lamivudine with their respective pediatric FDC formulations, taken as dispersion immediately or...” PMID 34817414 ↗ Mar 2022 “The preferentially recommended treatment of the study is atazanavir boosted with ritonavir, associated with a fixed combination of abacavir and lamivudine or emtricitabine + tenofovir” NCT00820118 ↗ “The abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) 600 milligrams (mg)/50 mg/300 mg fixed-dose combination (FDC) tablet is currently approved in the United States (US) and Europe.” NCT02539576 ↗ “the dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) fixed dose combination (FDC) tablet is being made available to women who become pregnant while participating in study ING117172” NCT02075593 ↗ Show 166 more sources
Known as	1592U89	“A Study to Test the Safety, Tolerance, and Metabolism of Abacavir (1592U89, ABC) With Standard Zidovudine (ZDV) Therapy in Newborn Infants Born to HIV-1 Infected Women” NCT00000864 ↗ 6 “In this open-label study antiretroviral-experienced patients receive Combivir (3TC/AZT tablet) plus 1592U89 (abacavir) and 141W94 twice daily for 48 weeks.” NCT00002217 ↗ “To assess the safety of single oral doses of 1592U89 (abacavir succinate, ABC) administered to HIV-positive individuals.” NCT00002141 ↗ “1592U89 (abacavir [ABC])” NCT00006617 ↗ “abacavir (ABC, 1592U89)” NCT00001086 ↗ “Abacavir (1592U89)” NCT00002419 ↗ “1592U89 (abacavir)” NCT00002216 ↗
Known as	abacavir succinate	“To assess the safety of single oral doses of 1592U89 (abacavir succinate, ABC) administered to HIV-positive individuals.” NCT00002141 ↗
Known as	abacavir sulfate	“The investigator selects either TRUVADA™, a tablet containing 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate p.o. q.d. or EPZICOM™/KIVEXA™, a tablet containing...” NCT02275780 ↗ 8 “Abacavir sulfate/lamivudine (ABC/3TC) and tenofovir DF/emtricitabine (TDF/FTC) are widely used nucleoside reverse transcriptase inhibitors for initial HIV-1 treatment.” PMID 19542866 ↗ Jul 2009 “ABC/3TC fixed dose combination (FDC) oral tablet, containing 600 mg of ABC (as abacavir sulfate) and 300 mg of 3TC” NCT02120352 ↗ “abacavir sulfate (ABC), lamivudine (3TC), and zidovudine (AZT)” NCT00084149 ↗ “Accepted NRTIs: abacavir sulfate (ABC)” NCT00039741 ↗ NCT00002217 ↗ NCT00102206 ↗ NCT00102960 ↗ NCT00006154 ↗
Known as	Abacavir sulphate	“containing 702 mg Abacavir sulphate which is equivalent to 600 mg ABC” NCT02105987 ↗
Known as	ABC	“Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC,...” NCT01363011 ↗ 62 “The investigators propose to evaluate the safety of combination therapy comprising the three nucleoside analog reverse-transcriptase inhibitors (NRTIs) zidovudine (AZT),...” NCT02363452 ↗ “The aim of this study was to investigate the effect on fasting lipid parameters of switching to tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC) from abacavir (ABC)...” PMID 22910324 ↗ Aug 2012 “The purpose of this study is to see if it is safe and effective to give HIV-positive patients a combination of anti-HIV drugs (abacavir \[ABC\] plus efavirenz \[EFV\] plus...” NCT00005018 ↗ “the presence of low level nucleoside reverse-transcriptase inhibitor-resistant human immunodeficiency virus in subjects receiving failing first-line regimens consisting of...” PMID 19032103 ↗ Jan 2009 “bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) or dolutegravir/lamivudine/abacavir (DTG/3TC/ABC), are associated with metabolic, renal, and cardiovascular adverse effects” NCT07138144 ↗ “The abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) 600 milligrams (mg)/50 mg/300 mg fixed-dose combination (FDC) tablet is currently approved in the United States (US) and Europe.” NCT02539576 ↗ “the dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) fixed dose combination (FDC) tablet is being made available to women who become pregnant while participating in study ING117172” NCT02075593 ↗ “NRTIs may include emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), zidovudine+FTC/TDF, abacavir (ABC)+TDF, ABC+FTC/TDF, ABC+lamivudine (3TC), or didanosine (DDI)+FTC.” NCT01440569 ↗ “A Study to Test the Safety, Tolerance, and Metabolism of Abacavir (1592U89, ABC) With Standard Zidovudine (ZDV) Therapy in Newborn Infants Born to HIV-1 Infected Women” NCT00000864 ↗ “Abacavir sulfate/lamivudine (ABC/3TC) and tenofovir DF/emtricitabine (TDF/FTC) are widely used nucleoside reverse transcriptase inhibitors for initial HIV-1 treatment.” PMID 19542866 ↗ Jul 2009 Show 52 more sources
Known as	ABC: abacavir: Ziagen	“ABC: abacavir: Ziagen” NCT02028676 ↗
Known as	Ziagen	“Ziagen (Abacavir) 300mg BID” NCT00004585 ↗
Action	Inhibit	“HIV nucleoside reverse transcriptase inhibitors (NRTI)” PMID 16103764 ↗ Sep 2005
Modality	Other / unclassified	“dual nucleosides” NCT00000919 ↗
Route	Oral	“abacavir 300 mg po BID” NCT00001766 ↗