Etravirine
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | INTELENCE | — | 2009-11-24 – 2018-11-06 | fda.gov ↗ |
| Approved | EU (EMA) | Intelence | — | 2008-08-28 | europa.eu ↗ |
| Approved | US (FDA) | INTELENCE | — | 2008-01-18 | fda.gov ↗ |
Trials 47
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 114 trials | ||||||
| Phase 1 | NCT04630002 | Oct 2020 → Oct 2021 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT04208373 | Dec 2019 → Mar 2020 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02818348 | Jun → Oct 2016 | HIV infectious disease | Fight AIDS and Infectious Diseases Foundation | Completed | No outcome recorded |
| Phase 1 | NCT02063360 | Feb → May 2014 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01876966 | Mar → Jul 2011 | HIV infectious disease | Janssen Pharmaceutica N.V., Belgium | Completed | No outcome recorded |
| Phase 1 | NCT01336829 | Mar → Sep 2011 | HIV infectious disease, hepatitis C virus infection | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT01090648 | Mar → May 2010 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT00855088 | Jul 2009 → Feb 2010 | AIDS | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 1 | NCT00871234 | Apr 2009 → Mar 2010 | HIV infectious disease | Indiana University | Completed | No outcome recorded |
| Phase 1 | NCT00828815 | Mar → Nov 2009 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT00774111 | Oct → Dec 2008 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00767117 | Sep → Dec 2008 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT00740389 | Sep 2008 → Jan 2009 | AIDS, fungal infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 1 | NCT00531323 | Sep → Dec 2007 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01504841 | Mar 2013 → Jul 2018 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 213 trials · 1 missed | ||||||
| Phase 2 | NCT02212379 | Jan 2015 → Oct 2017 | HIV infectious disease | ANRS, Emerging Infectious Diseases | Completed | No outcome recorded |
| Phase 2 | NCT01199939 | May 2010 → Oct 2012 | HIV infectious disease | Tibotec, Inc | Completed | No outcome recorded |
| Phase 2 | NCT00959894 | Sep 2009 → Feb 2014 | HIV infectious disease | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 2 | NCT00896051 | Aug 2009 → Apr 2012 | AIDS | Janssen R&D Ireland | Completed | No outcome recorded |
| Phase 2 | NCT00903682 | Jun 2009 → Feb 2010 | AIDS | Janssen-Cilag International NV | Completed | No outcome recorded |
| Phase 2 | NCT00665847 | Nov 2008 → May 2011 | — | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 2 | NCT00534352 | Jan → May 2008 | HIV infectious disease | Tibotec, Inc | Completed | No outcome recorded |
| Phase 2 | NCT00460382 | May 2007 → Mar 2008 | HIV infectious disease | French National Agency for Research on AIDS and Viral Hepatitis | Completed | No outcome recorded |
| Phase 2 | NCT00128830 | Jun 2005 → Aug 2008 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 2 | NCT00225303 | Mar 2005 → Jun 2006 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | Missed primary |
| Phase 2 | NCT00111280 | Sep 2004 → Mar 2007 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 2 | NCT00081978 | Mar 2004 → Oct 2005 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 2 | NCT00412646 | Jun 2002 → Nov 2006 | — | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT00624195 | Mar 2007 → Feb 2012 | HIV infectious disease | University of California, San Diego | Completed | Missed primary |
| Phase 37 trials · 1 met primary | ||||||
| Phase 3 | NCT01543035 | Dec 2011 → Jul 2013 | HIV infectious disease | Calmy Alexandra | Completed | No outcome recorded |
| Phase 3 | NCT00980538 | Dec 2009 → Nov 2020 | HIV infectious disease | Janssen Sciences Ireland UC | Completed | No outcome recorded |
| Phase 3 | NCT01034917 | Dec 2009 → Dec 2011 | HIV infectious disease | Germans Trias i Pujol Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00855335 | Apr 2009 → Aug 2016 | HIV infectious disease, pregnancy disorder | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00537394 | Jan 2008 → May 2012 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 3 | NCT00460746 | May 2007 → Oct 2008 | HIV infectious disease | Tibotec, Inc | Completed | No outcome recorded |
| Phase 3 | NCT00359021 | Jun 2006 → Jan 2012 | — | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| 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 | NCT01422330 | Sep 2011 → Nov 2013 | HIV infectious disease | Janssen R&D Ireland | Completed | No outcome recorded |
| Phase 4 | NCT01118871 | May 2010 → May 2013 | HIV infectious disease | Imperial College London | Terminated | No outcome recorded |
| Phase 4 | NCT01121809 | Apr → Oct 2010 | HIV infectious disease | Hospitales Universitarios Virgen del Rocío | Completed | No outcome recorded |
| Phase 4 | NCT01045369 | Jan 2010 → Apr 2011 | HIV infectious disease | Therapeutic Concepts | Completed | No outcome recorded |
| Phase 4 | NCT00855413 | Mar 2009 → Nov 2013 | HIV infectious disease | University of North Carolina, Chapel Hill | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable4 trials | ||||||
| — | NCT01427504 | Aug → Dec 2011 | HIV infectious disease, hepatitis C virus infection | University of Colorado, Denver | Completed | No outcome recorded |
| — | NCT01625169 | Apr 2010 → Dec 2012 | HIV infectious disease | University of Southern California | Completed | No outcome recorded |
| — | NCT00792584 | Nov 2008 | sleep disorder | University Hospital, Geneva | Completed | No outcome recorded |
| — | NCT00884793 | Sep 2008 → Dec 2009 | HIV infectious disease | University of California, San Francisco | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT00354627 | — | — | Tibotec Pharmaceuticals, Ireland | Approved for marketing | No outcome recorded |
| Comparator or background therapy17 trials | ||||||
| Phase 1 | NCT00867152 Background | Apr → May 2009 | — | ViiV Healthcare | 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 | NCT04273165 Comparator | Sep 2020 → Jan 2023 | Friedreich ataxia | IRCCS Eugenio Medea | Completed | No outcome recorded |
| Phase 2 | NCT01254656 Comparator | Feb 2011 → Apr 2013 | — | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT01199731 Comparator | Oct 2010 → Jul 2011 | HIV infectious disease | ViiV Healthcare | Terminated | No outcome recorded |
| Phase 2 | NCT00823979 Comparator | Mar 2009 → Oct 2012 | — | Pfizer | Terminated | No outcome recorded |
| 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 | NCT02302547 Comparator | Dec 2014 → Aug 2017 | HIV infectious disease | University Hospital, Tours | Completed | No outcome recorded |
| Phase 3 | NCT02157311 Background | Jul 2014 → Jan 2016 | 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 | NCT00792324 Comparator | Jun 2008 → Aug 2009 | HIV infectious disease | St Stephens Aids Trust | Completed | No outcome recorded |
| Phase 3 | NCT00255099 Comparator | Dec 2005 → Jan 2007 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 3 | NCT00254046 Comparator | Nov 2005 → Feb 2007 | HIV infectious disease | Tibotec Pharmaceuticals, Ireland | Completed | No outcome recorded |
| Phase 4 | NCT01189695 Comparator | Dec 2010 → Dec 2012 | AIDS | Bamrasnaradura Infectious Diseases Institute | 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 |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 71 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | etravirine | “Generic names: Efavirenz/Emtricitabine/Tenofovir, Lamivudine/Zidovudine, Emtricitabine, Lamivudine, Abacavir/Lamivudine, Zidovudine, Abacavir/Lamivudine/Zidovudine,...” NCT00624195 ↗54“This study aims to provide information about the safety and pharmacokinetic drug-drug interactions between darunavir/cobicistat (800/150mg QD) and etravirine (400mg QD) in...” NCT02818348 ↗ “Etravirine (ETR; also known as TMC125) is a new nonnucleoside reverse-transcriptase inhibitor with activity against wild-type and nonnucleoside reverse-transcriptase...” PMID 18764771 ↗ Oct 2008 “In dyslipidaemic patients with HIV infection, we assessed the efficacy of replacing boosted protease inhibitor (bPI) or efavirenz (EFV) by etravirine (ETR) as an alternative to...” PMID 25989829 ↗ Jul 2015 “Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial.” PMID 17617270 ↗ Jul 2007 “Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine).” NCT00884793 ↗ “Tenofovir+Emtricitabine+Third agent (Including a non nucleoside reverse transcriptase inhibitor: efavirenz or nevirapine or etravirine or rilpivirine” NCT02302547 ↗ “Efficacy and safety of etravirine (TMC125) in treatment-experienced HIV-1-infected patients: 48-week results of a phase IIb trial.” PMID 19114852 ↗ Jan 2009 “200 mg (2 tablets) ETR (etravirine) will be given twice a day from day 1 to 10 with a morning dose only on day 11.” NCT01336829 ↗ “compared the efficacy and safety of TMC125 (etravirine) with an investigator-selected protease inhibitor (PI)” PMID 18795960 ↗ Sep 2008 “Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-2” PMID 17617271 ↗ Jul 2007 |
| Known as | ETR | “This is a Phase I, partially randomized, open-label, single-center, two-way, two-period cross-over study to investigate the pharmacokinetic interaction between etravirine (ETR)...” NCT01876966 ↗14“Etravirine (ETR; also known as TMC125) is a new nonnucleoside reverse-transcriptase inhibitor with activity against wild-type and nonnucleoside reverse-transcriptase...” PMID 18764771 ↗ Oct 2008 “In dyslipidaemic patients with HIV infection, we assessed the efficacy of replacing boosted protease inhibitor (bPI) or efavirenz (EFV) by etravirine (ETR) as an alternative to...” PMID 25989829 ↗ Jul 2015 “Etravirine (ETR) 200 mg taken twice daily as two 100-mg tablets following a meal (morning and evening) for at least the first two weeks of the 48-week Treatment Period.” NCT00896051 ↗ “This is open label continued access trial for HIV-1 infected children/adolescents who have completed treatment in clinical (parent) trial with etravirine (ETR)” NCT00980538 ↗ “Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.” NCT02212379 ↗ “200 mg (2 tablets) ETR (etravirine) will be given twice a day from day 1 to 10 with a morning dose only on day 11.” NCT01336829 ↗ “Etravirine (ETR) was approved for patients with virological failure and antiretroviral resistance mutations.” PMID 24503952 ↗ Feb 2014 “One etravirine (ETR) 200 mg uncoated oral tablet and one etravirine (ETR) 200 mg film-coated tablet” NCT01090648 ↗ “etravirine (ETR; Intelence®)” NCT02605954 ↗ “etravirine (ETR;Intelence®)” NCT02616783 ↗ |
| Known as | Etravirina | ChEMBL registry synonym — accepted as the source's own label CHEMBL308954 ↗ |
| Known as | etravirine (Intelence | “etravirine (Intelence” NCT00884793 ↗ |
| Known as | ETV | “control arm of open-label etravirine (ETV) 200 mg twice daily” NCT01199731 ↗ |
| Known as | INTELENCE | “Etravirine is a diarylpyrimidine that acts as a non-nucleoside reverse transcriptase inhibitor. It was approved in 2008 by the FDA (tradename Intelence) for the treatment of...” NCT04273165 ↗6“The Intelence aNd pRezista Once A Day Study (INROADS): a multicentre, single-arm, open-label study of etravirine and darunavir/ritonavir as dual therapy in HIV-1-infected early...” PMID 25585528 ↗ Jan 2015 “The purpose of this study is to see if using a combination of other drug classes, like the ones that Kaletra® and Intelence™ belong to, can still help reduce the amount of HIV...” NCT01045369 ↗ “Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal.” NCT02212379 ↗ “etravirine (ETR; Intelence®)” NCT02605954 ↗ “etravirine (ETR;Intelence®)” NCT02616783 ↗ |
| Known as | R-165335 | ChEMBL registry synonym — accepted as the source's own label CHEMBL308954 ↗ |
| Known as | TMC125 | “Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1-infected patients in DUET-2” PMID 17617271 ↗ Jul 200715“TMC125 (etravirine) 200 mg (1\*200 mg/2\*100 mg) tablets twice daily up to 12 weeks postpartum.” NCT00855335 ↗ “etravirine (ETR, TMC125)” NCT00903682 ↗ “Etravirine (TMC125)” NCT00665847 ↗ |
| Action | Inhibit | “The purpose of this study is to investigate the ability of TMC125, a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), to lower the amount of virus in your blood when...” NCT00081978 ↗ |
| Modality | Small molecule | “TMC125 is a diarylpyrimidine derivative” NCT00792324 ↗ |
| Route | Oral | “Patients will take 200 mg oral doses of TMC125 tablets or placebo tablets” NCT00254046 ↗ |