Didanosine

also known as ddI · 2' 3'-Dideoxyinosine · Videx · ddI EC · BMY-40900 · Ddl-EC · didanosine EC

Developed for: HIV infectious disease · AIDS · AIDS dementia complex
Investigated by: National Institute of Allergy and Infectious Diseases (NIAID) · Bristol-Myers Squibb · Glaxo Wellcome · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Gilead Sciences · Triangle Pharmaceuticals
+37 more
· Dupont Applied Biosciences · Merck Sharp & Dohme LLC · ANRS, Emerging Infectious Diseases · Boehringer Ingelheim · French National Agency for Research on AIDS and Viral Hepatitis · Hoffmann-La Roche · Pharmacia and Upjohn · Upjohn · 407 Doctors · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Argus Pharmaceuticals · Botswana Ministry of Health · Chiron Corporation · Clinical Trial Agency of HIV Study Group · Dupont Merck · HIV Prevention Trials Network · Harvard School of Public Health (HSPH) · Hospital de Granollers · ICN Pharmaceuticals · Indian Council of Medical Research · International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Janssen Research & Development, LLC · Kirby Institute · McGill University Health Centre/Research Institute of the McGill University Health Centre · Ministry of Science and Technology of the People´s Republic of China · National AIDS Control Organisation · National Cancer Institute (NCI) · National Heart, Lung, and Blood Institute (NHLBI) · Novum · PPD Development, LP · Peking Union Medical College · PharmaResearch · Princess Marina Hospital, Botswana · Research Institute for Development · St Vincent's Hospital, Sydney · Tuberculosis Research Centre, India · Weill Medical College of Cornell University

Regulatory milestones approvals, filings & regulatory actions · 10 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansions (2)	US (FDA)	VIDEX EC	—	2002-01-29 – 2008-09-29	fda.gov ↗
Label expansions (7)	US (FDA)	VIDEX	—	1992-09-25 – 2002-04-01	fda.gov ↗
Approved	US (FDA)	VIDEX	—	1991-10-09	fda.gov ↗

Trials 103 · started per year

today

US approved 1991

19901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 122 trials · 1 missed
Phase 1	NCT02251873	Sep 2001 → Mar 2002	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT00002360	Mar 1999	HIV infectious disease	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 1	NCT00000742	? → Oct 1993	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00002096	—	HIV infectious disease, cytomegalovirus infection	Hoffmann-La Roche	Completed	No outcome recorded
Phase 1	NCT00000753	? → Feb 1995	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00000833	? → Jul 1998	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00001074	? → Jan 2000	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00000810	? → Jan 1996	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00000902	? → Apr 2002	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00000839	? → Jun 2001	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00001108	? → Jun 2000	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00002014	—	HIV infectious disease	Glaxo Wellcome	Completed	Missed primary
Phase 1	NCT00000954	? → Sep 1996	HIV infectious disease, Kaposi's sarcoma	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00000865	? → Apr 1998	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00000652	? → Nov 1995	HIV infectious disease	National Cancer Institute (NCI)	Completed	No outcome recorded
Phase 1	NCT00000656	? → Nov 1993	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00000772	? → Feb 1995	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00000669	—	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00000710	? → May 1990	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00002313	—	HIV infectious disease	Argus Pharmaceuticals	Completed	No outcome recorded
Phase 1	NCT00001049	? → Jun 1998	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00000814	? → Nov 1998	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded

Phase 1/21 trial
Phase 1/2	NCT00016718	Aug 2001 → Jan 2009	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 233 trials · 1 missed
Phase 2	NCT00109590	Jun 2006 → Oct 2008	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00122538	Feb 2006 → Nov 2008	AIDS	French National Agency for Research on AIDS and Viral Hepatitis	Completed	No outcome recorded
Phase 2	NCT00142337	Dec 2004 → May 2006	HIV infectious disease	Research Institute for Development	Completed	No outcome recorded
Phase 2	NCT00196599	Feb 1999 → Sep 2004	HIV infectious disease	ANRS, Emerging Infectious Diseases	Completed	No outcome recorded
Phase 2	NCT00001045	? → Oct 1998	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000918	? → Feb 2002	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00006339	—	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Withdrawn	No outcome recorded
Phase 2	NCT00002420	—	HIV infectious disease	Bristol-Myers Squibb	Terminated	No outcome recorded
Phase 2	NCT00000671	? → Mar 1992	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000924	? → Jun 2001	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000657	? → Sep 1992	AIDS dementia complex, HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00001066	? → Jan 2001	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000979	? → Oct 1992	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00002418	—	HIV infectious disease	Bristol-Myers Squibb	Terminated	No outcome recorded
Phase 2	NCT00000885	? → Jun 2003	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Missed primary
Phase 2	NCT00000672	? → Feb 1993	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00001063	? → Nov 1997	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00001025	? → May 1995	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000823	? → Feb 2000	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00007202	? → Oct 2006	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00008866	—	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Withdrawn	No outcome recorded
Phase 2	NCT00001029	? → May 1993	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000963	? → Sep 1995	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000781	? → Sep 1996	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00002234	—	HIV infectious disease	Gilead Sciences	Completed	No outcome recorded
Phase 2	NCT00000891	? → May 2004	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000838	? → Mar 1998	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000625	? → Nov 1995	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000916	? → Aug 2004	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000851	? → Oct 1998	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00002225	—	HIV infectious disease	Dupont Merck	Completed	No outcome recorded
Phase 2	NCT00000831	? → May 1998	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00001057	? → May 1995	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded

Phase 316 trials · 2 met primary · 1 missed
Phase 3	NCT01440569	Sep 2011 → Aug 2012	AIDS	Gilead Sciences	Completed	No outcome recorded
Phase 3	NCT00332306	Jun 2006 → Jun 2009	HIV infectious disease, tuberculosis	Tuberculosis Research Centre, India	Unknown	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	NCT00074581	Feb 2005 → May 2015	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Met primary
Phase 3	NCT00158470	Sep 2003 → May 2007	HIV infectious disease	French National Agency for Research on AIDS and Viral Hepatitis	Completed	No outcome recorded
Phase 3	NCT00197613	Dec 2002 → Dec 2007	AIDS	Harvard School of Public Health (HSPH)	Completed	No outcome recorded
Phase 3	NCT00196612	Apr 2001 → Sep 2004	HIV infectious disease	ANRS, Emerging Infectious Diseases	Completed	No outcome recorded
Phase 3	NCT00006397	Aug 2000 → ?	HIV infectious disease	PPD Development, LP	Unknown	No outcome recorded
Phase 3	NCT00002429	Jul 1999 → Jan 2001	HIV infectious disease	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 3	NCT00002224	Mar 1999	HIV infectious disease	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 3	NCT00006154	—	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 3	NCT00000637	? → Sep 1996	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	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	NCT00008489	—	HIV infectious disease	PharmaResearch	Unknown	No outcome recorded
Phase 3	NCT00001022	? → Dec 1995	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded

Phase 410 trials · 1 met primary
Phase 4	NCT06337032	Aug 2024 → Mar 2034 expected	HIV infectious disease	Gilead Sciences	Recruiting	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	NCT00084136	May 2005 → May 2010	HIV infectious disease	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	Completed	Mixed
Phase 4	NCT00618176	Jan 2005 → Sep 2006	HIV infectious disease	Peking Union Medical College	Completed	No outcome recorded
Phase 4	NCT00256828	Jun 2004 → Nov 2006	HIV infectious disease	Clinical Trial Agency of HIV Study Group	Completed	Met primary
Phase 4	NCT00214435	May 2004 → ?	AIDS	407 Doctors	Unknown	No outcome recorded
Phase 4	NCT00192660	Feb 2003 → Oct 2006	cardiovascular disorder, lipodystrophy	Kirby Institute	Completed	No outcome recorded
Phase 4	NCT00005018	Jul 1999 → Oct 2000	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
Phase 4	NCT00002386	—	HIV infectious disease, hemophilia A	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 4	NCT00002376	—	HIV infectious disease	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase not applicable21 trials · 1 missed
—	NCT00091936	Aug 2009 → ?	HIV infectious disease, tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
—	NCT00080522	Feb 2005 → Jan 2007	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
—	NCT00002207	Feb 2004	HIV infectious disease	Bristol-Myers Squibb	Completed	No outcome recorded
—	NCT00116415	Mar 2002 → Nov 2004	AIDS	Bristol-Myers Squibb	Completed	No outcome recorded
—	NCT00002411	Mar 1998 → Sep 1999	HIV infectious disease	Bristol-Myers Squibb	Completed	No outcome recorded
—	NCT00002176	May 1997 → Mar 2000	HIV infectious disease	Bristol-Myers Squibb	Completed	No outcome recorded
—	NCT00002177	May 1997 → Mar 2000	HIV infectious disease	Bristol-Myers Squibb	Completed	No outcome recorded
—	NCT00000969	? → Sep 1992	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
—	NCT00000922	? → Jan 2003	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Missed primary
—	NCT00002168	—	HIV infectious disease	Bristol-Myers Squibb	Completed	No outcome recorded
—	NCT00002028	—	HIV infectious disease	Bristol-Myers Squibb	Completed	No outcome recorded
—	NCT00001997	—	HIV infectious disease	Chiron Corporation	Completed	No outcome recorded
—	NCT00002001	—	HIV infectious disease	Glaxo Wellcome	Completed	No outcome recorded
—	NCT00002035	? → Apr 1992	HIV infectious disease	Bristol-Myers Squibb	Completed	No outcome recorded
—	NCT00002407	—	HIV infectious disease	Weill Medical College of Cornell University	Completed	No outcome recorded
—	NCT00002280	? → Nov 1994	HIV infectious disease	Bristol-Myers Squibb	Completed	No outcome recorded
—	NCT00000919	? → Nov 2002	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
—	NCT00002274	—	HIV infectious disease, progressive multifocal leukoencephalopathy	Bristol-Myers Squibb	Completed	No outcome recorded
—	NCT00002211	—	HIV infectious disease	Pharmacia and Upjohn	Completed	No outcome recorded
—	NCT00001024	? → Jun 2002	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
—	NCT00014937	? → Dec 2004	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded

Comparator or background therapy39 trials
Phase 1	NCT00032669 Background	Mar 2002 → Apr 2006	HIV infectious disease	National Cancer Institute (NCI)	Completed	No outcome recorded
Phase 1	NCT00002427 Background	May 1999 → ?	HIV infectious disease	Research Institute for Genetic and Human Therapy	Completed	No outcome recorded
Phase 1	NCT00002098 Background	—	HIV infectious disease	AJI Pharma USA	Completed	No outcome recorded
Phase 1	NCT00001035 Background	? → Sep 1996	HIV infectious disease, hepatitis C virus infection	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00000760 Background	—	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1	NCT00000971 Background	—	HIV infectious disease, Mycobacterium avium complex disease	Abbott	Completed	No outcome recorded
Phase 1	NCT00000822 Background	? → May 1999	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 1/2	NCT00364793 Background	Feb 2007 → Dec 2011	HIV infectious disease	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 2	NCT00002240 Background	Mar 1999 → Dec 2001	HIV infectious disease	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 2	NCT00002905 Background	Jun 1995 → ?	lymphoma	Centro di Riferimento Oncologico - Aviano	Unknown	No outcome recorded
Phase 2	NCT00001087 Background	? → Jul 2000	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000870 Background	? → Mar 2007	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000770 Background	? → Nov 1994	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000982 Background	? → Sep 1996	HIV infectious disease, brain disorder	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00002099 Background	—	HIV infectious disease	AJI Pharma USA	Unknown	No outcome recorded
Phase 2	NCT00001048 Background	? → Apr 1997	HIV infectious disease, progressive multifocal leukoencephalopathy	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00002162 Background	—	HIV infectious disease	Hoffmann-La Roche	Completed	No outcome recorded
Phase 2	NCT00001114 Background	? → Mar 2000	HIV infectious disease, Kaposi's sarcoma	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00001122 Background	? → Oct 2003	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000939 Background	? → Jan 2000	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00000803 Background	? → Mar 1997	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 2	NCT00002412 Background	—	HIV infectious disease	Triangle Pharmaceuticals	Completed	No outcome recorded
Phase 2/3	NCT02016924 Background	Jan 2014 → Jun 2025 overdue	AIDS	Gilead Sciences	Active not recruiting	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	NCT00928187 Comparator	Nov 2009 → Sep 2013	HIV infectious disease	ANRS, Emerging Infectious Diseases	Completed	No outcome recorded
Phase 3	NCT00708162 Background	Jul 2008 → Dec 2010	HIV infectious disease	Gilead Sciences	Completed	Met primary
Phase 3	NCT00427297 Comparator	Sep 2007 → May 2009	HIV infectious disease	University of Washington	Terminated	No outcome recorded
Phase 3	NCT00398996 Comparator	Jun 2005 → Jul 2010	HIV infectious disease, pulmonary tuberculosis	Centre for the AIDS Programme of Research in South Africa	Completed	No outcome recorded
Phase 3	NCT00006208 Background	Aug 2000 → ?	HIV infectious disease	Triangle Pharmaceuticals	Unknown	No outcome recorded
Phase 3	NCT00002109 Background	—	HIV infectious disease	Immunobiology Research Institute	Completed	No outcome recorded
Phase 3	NCT00002230 Background	—	HIV infectious disease	Northwestern University	Completed	No outcome recorded
Phase 3	NCT00002123 Background	—	HIV infectious disease	Pharmacia and Upjohn	Completed	No outcome recorded
Phase 4	NCT00342355 Comparator	Jan 2004 → Mar 2008	HIV infectious disease	National Institutes of Health Clinical Center (CC)	Completed	No outcome recorded
Phase 4	NCT00005000 Background	Dec 1999 → ?	HIV infectious disease	Agouron Pharmaceuticals	Unknown	No outcome recorded
—	NCT00428116 Comparator	Sep 2007 → Jul 2013	HIV infectious disease	University of Washington	Terminated	No outcome recorded
—	NCT00034086 Background	? → Jun 2006	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
—	NCT00051090 Background	—	HIV infectious disease, hepatitis B virus infection	National Institute of Allergy and Infectious Diseases (NIAID)	Withdrawn	No outcome recorded
—	NCT00000923 Background	? → Aug 2004	HIV infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 2

Date	Issuer	Release
2003-02-11	Gilead Sciences	Results Phase III Data Show Emtricitabine Maintains Viral Load Suppression as Part of Once-Daily, Protease-Sparing Anti-HIV Regimen gilead.com ↗ At 48 weeks, 94 percent of patients receiving the once-daily regimen of emtricitabine, didanosine and efavirenz had HIV RNA levels (viral load) less than 400 copies/mL, compared to 92 percent randomized to continue therapy in the PI-based arm (intent to treat population, assays performed at local laboratories at investigational centers).
2001-06-05	Gilead Sciences	Results Gilead Sciences Presents Data Characterizing Resistance Profile of Tenofovir DF, Investigational Agent for the Treatment of HIV gilead.com ↗ The results demonstrate that chain-terminator removal occurs more readily with nucleosides than nucleotides and may contribute to the higher-level of resistance associated with nucleosides.

All press releases naming this drug 2 releases

Date	Issuer	Release
2003-02-11	Gilead Sciences	Phase III Data Show Emtricitabine Maintains Viral Load Suppression as Part of Once-Daily, Protease-Sparing Anti-HIV Regimen gilead.com ↗
2001-06-05	Gilead Sciences	Gilead Sciences Presents Data Characterizing Resistance Profile of Tenofovir DF, Investigational Agent for the Treatment of HIV gilead.com ↗

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 147 sources stand behind the page.

Field	Value	Cited text
Known as	Didanosine	“It may include one or two nucleoside reverse transcriptase inhibitors, such as zidovudine, didanosine, lamuvidine, zalcitabine, stavudine), a non- nucleoside reverse...” NCT00032669 ↗ 140 “An Open Label, Randomised, Parallel Group Study of the Drug-drug Pharmacokinetic Interaction of Steady State Tipranavir (SEDDS SEC) 500 mg and Ritonavir (Soft Gelatin Capsules)...” NCT02251873 ↗ “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 ↗ “A Randomised, Multi-Centre, Open-Label Study in Well-Controlled Treatment-Experienced HIV-Infected Patients to Assess Compliance With a Once-Daily Regimen of Lamivudine,...” NCT00214435 ↗ “Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC,...” NCT01363011 ↗ “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 ↗ “the additional agents include abacavir (ABC), Combivir® (lamivudine (LAM)/zidovudine (ZDV) coformulated), didanosine, emtricitabine (FTC), enfuvirtide” NCT00708162 ↗ “Second line regimen - ddI/ABC/LPV/r (didanosine/abacavir/lopinavir-ritonavir (Kaletra))” NCT00428116 ↗ “Didanosine (250 mg or 400 mg)” NCT01605084 ↗ “didanosine (ddI)” NCT06337032 ↗ “didanosine (ddI)” NCT02016924 ↗ Show 130 more sources
Known as	2' 3'-Dideoxyinosine	“A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-Dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related...” NCT00002028 ↗ 5 “A Randomized Comparative Trial of Two Doses of 2',3'-Dideoxyinosine (ddI) in Children With Symptomatic HIV Infection Who Are Either Unresponsive to Zidovudine and/or Who Are...” NCT00000963 ↗ “An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex” NCT00000672 ↗ “Phase I/II Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients” NCT00002098 ↗ “Combination Zidovudine and 2' 3'-Dideoxyinosine (Didanosine)” NCT00000656 ↗ “2',3'-Dideoxyinosine (ddI) (BMY-40900)” NCT00002035 ↗
Known as	BMY-40900	“An Efficacy Study of 2',3'-Dideoxyinosine (ddI) (BMY-40900) Administered Orally Twice Daily to Zidovudine Intolerant Patients With AIDS or AIDS-Related Complex” NCT00000672 ↗ 1 “2',3'-Dideoxyinosine (ddI) (BMY-40900)” NCT00002035 ↗
Known as	ddI	“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 ↗ 94 “Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC,...” NCT01363011 ↗ “To compare the efficacy of lamivudine (3TC) and zidovudine (AZT) in combination versus the better of didanosine (ddI) monotherapy or ddI/AZT combination, in symptomatic HIV-1...” NCT00001066 ↗ “The purpose of this study is to make didanosine (ddI) available to children with AIDS who are clinically deteriorating on zidovudine (AZT) or intolerant to AZT and cannot enter...” NCT00002280 ↗ “To determine the effects of zidovudine (AZT) alone and in combination with didanosine (ddI) on viral load in the lymphoid tissue and blood of antiretroviral-naive, HIV-infected...” NCT00001057 ↗ “Primary: To compare the efficacy of zidovudine ( AZT ) given alone versus AZT plus didanosine ( ddI ) versus AZT plus zalcitabine ( dideoxycytidine; ddC ) in delaying the...” NCT00001022 ↗ “A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-Dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related...” NCT00002028 ↗ “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 ↗ “To assess the pharmacokinetics, safety, and toxicity of intravenous and oral didanosine (ddI) administration in third trimester pregnant women who are HIV positive but are...” NCT00000839 ↗ “Double reverse transcriptase inhibitor (RTI) therapy consisting of any two therapy combinations of: didanosine (ddI), lamivudine (3TC), stavudine (d4T) or zidovudine (ZDV),...” NCT00002376 ↗ “Hydroxyurea, an agent broadly used for its antineoplastic properties, has been shown to inhibit HIV-1 in vitro and in vivo when combined with the nucleoside analogue reverse...” NCT00008866 ↗ Show 84 more sources
Known as	ddI EC	“Arm I options are enteric-coated didanosine (ddI-EC) plus lamivudine (3TC), ddI-EC plus zidovudine (ZDV), ZDV plus 3TC (or Combivir), stavudine (d4T) plus 3TC, or ddI-EC plus...” NCT00014937 ↗ 2 “enteric-coated didanosine (ddI-EC), stavudine (d4T), and the HIV-1 protease inhibitor, BMS-232632” NCT00007202 ↗ “This study tests a new form of didanosine, ddI EC, a coated pill” NCT00002429 ↗
Known as	Ddl-EC	“Didanosine Enteric Coated (Ddl-EC) in Combination With Lamivudine (3TC)” NCT00116415 ↗
Known as	didanosine EC	“efavirenz; didanosine EC; lamivudine” NCT00116415 ↗
Known as	Videx	“A Treatment IND (Investigational New Drug) Protocol for the Use of Videx (2',3'-Dideoxyinosine, ddI) in Patients With Acquired Immunodeficiency Syndrome (AIDS) or AIDS- Related...” NCT00002028 ↗ 3 “Videx (Didanosine; ddI)” NCT00002234 ↗ “Videx (Didanosine)” NCT00002420 ↗ “Videx (Didanosine)” NCT00002168 ↗
Action	Inhibit	“The drug ddI is an antiviral agent that inhibits replication of HIV with less apparent toxicity than AZT.” NCT00000671 ↗
Modality	Small molecule	“nucleoside analog” NCT00000781 ↗
Route	Oral	“orally administered didanosine (ddI)” NCT00000657 ↗