Combivir: trials, targets and approvals

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	EU (EMA)	Combivir	—	1998-03-18	europa.eu ↗
Approved	US (FDA)	COMBIVIR	—	1997-09-26	fda.gov ↗

Trials 3

today

US approved 1997

EU approved 1998

NCT00385645 · Ph 4 NCT00433719 · not/applicable NCT00043888 · Ph 3

1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 31 trial
Phase 3	NCT00043888	Jan 2002 → May 2003	HIV infectious disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 41 trial · 1 missed
Phase 4	NCT00385645	May 2006 → Aug 2009	HIV infectious disease	Hospital Clinic of Barcelona	Completed	Missed primary
Phase not applicable1 trial
—	NCT00433719	Sep 2005 → Dec 2008	HIV infectious disease, meningeal tuberculosis	University of Oxford	Unknown	No outcome recorded
Comparator or background therapy5 trials
Phase 2	NCT00104429 Background	Jan 2005 → Jan 2006	HIV infectious disease	ViiV Healthcare	Terminated	No outcome recorded
Phase 3	NCT00708162 Background	Jul 2008 → Dec 2010	HIV infectious disease	Gilead Sciences	Completed	Met primary
Phase 4	NCT02057796 Background	Sep 2014 → Apr 2018	HIV infectious disease	ANRS, Emerging Infectious Diseases	Completed	Missed primary
Phase 4	NCT00960622 Comparator	Aug 2006 → Jul 2009	HIV infectious disease	St. Luke's-Roosevelt Hospital Center	Completed	Missed primary
—	NCT06609941 Background	Jun 2024 → Jan 2025 overdue	asthma	Foundation University Islamabad	Recruiting	No outcome recorded

Press releases naming this drug 10 releases

Date	Issuer	Release
2007-10-29	Gilead Sciences	Gilead Announces 48-Week Data Evaluating Switching from Combivir(R) To Truvada(R) Among Virologically-Suppressed HIV Patients gilead.com ↗
2007-07-23	Gilead Sciences	144-Week Data from Gilead's Study 934 Comparing Truvada(R) to Combivir(R) Both in Combination with Sustiva(R) Presented At International AIDS Society Meeting in Sydney gilead.com ↗
2006-12-15	Gilead Sciences	96-Week Data From Gilead's Study 934 Comparing Viread(R) and Emtriva(R) to Combivir(R) Both in Combination With Sustiva(R) Published in Journal of Acquired Immune Deficiency Syndrome gilead.com ↗
2006-08-14	Gilead Sciences	96-Week Data from Gilead's Study 934 Comparing Viread(R) and Emtriva(R) to Combivir(R) Both in Combination with Sustiva(R) Presented at XVI International AIDS Conference gilead.com ↗
2006-01-18	Gilead Sciences	Data Comparing Viread(R) and Emtriva(R) to Combivir(R) as Part of Combination HIV Therapy Published in New England Journal of Medicine gilead.com ↗
2005-11-17	Gilead Sciences	Preliminary 24-Week Data Evaluating the Impact of Switching from Twice-Daily Combivir(R) to Once-Daily Truvada(R) in Patients with HIV Presented at 10th European AIDS Conference gilead.com ↗
2005-02-03	Gilead Sciences	Gilead Announces Preliminary 48-Week Data From Study 934 Comparing Viread and Emtriva to Combivir Both in Combination With Sustiva in Patients With HIV gilead.com ↗
2004-10-31	Gilead Sciences	Interim 24-Week Data from Study 934 Comparing a Regimen of Viread and Emtriva Versus Combivir, Both in Combination with Efavirenz, in Patients with HIV Presented at 44th ICAAC gilead.com ↗
2004-08-26	Gilead Sciences	Gilead Announces Preliminary 24-Week Data from Study 934 Comparing Viread and Emtriva to Combivir Both in Combination With Efavirenz In Patients With HIV gilead.com ↗
2003-08-11	Gilead Sciences	Gilead Initiates Study 934, a 48-Week Clinical Trial Evaluating Viread and Emtriva versus Combivir gilead.com ↗

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

Field	Value	Cited text
Known as	Combivir	“the additional agents include abacavir (ABC), Combivir® (lamivudine (LAM)/zidovudine (ZDV) coformulated)” NCT00708162 ↗ 7 “Combivir (Nucleoside analogue - reverse transcriptase inhibitor)” NCT06609941 ↗ NCT00433719 ↗ NCT02057796 ↗ NCT00385645 ↗ NCT00104429 ↗ NCT00043888 ↗ NCT00960622 ↗
Action	Inhibit	“reverse transcriptase inhibitor” NCT06609941 ↗