| Intelence (etravirine) / J&J |
| Completed | 2b | 211 | US, Europe | TMC125 | Tibotec Pharmaceuticals, Ireland | HIV Infection | | 10/05 | | |
SENSE, NCT00903682 / 2008-008655-42: A Clinical Trial Comparing the Tolerability of Etravirine to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Treatment-naive HIV-1 Infected Patients |
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| Completed | 2b | 157 | Europe, RoW | etravirine (ETR, TMC125), efavirenz (EFV) | Janssen-Cilag International NV | HIV Infection, HIV, Acquired Immunodeficiency Syndrome | 02/10 | 01/11 | | |
SONNET, NCT01199731: Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection |
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| Terminated | 2b | 30 | US, Canada, Europe | GSK2248761 100 mg once daily, GSK2248761 200 mg once daily, Etravirine | ViiV Healthcare, GlaxoSmithKline | Infection, Human Immunodeficiency Virus | 07/11 | 07/11 | | |
NCT00823979 / 2007-004392-19: A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1 |
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| Terminated | 2b | 105 | US, Europe, RoW | UK-453,061 Dose 1, UK-453,061 Dose 2, Etravirine | Pfizer | HIV-1 | 10/12 | 10/12 | | |
NCT00225303: TMC125-C227: A Phase II Randomized, Active-Controlled, Open Label Trial to Investigate the Efficacy and Tolerability of TMC125 in HIV-1 Infected Subjects, Who Are PI-Naive and With Documented Genotypic Evidence of NNRTI Resistance From Previous NNRTI Use |
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| Completed | 2 | 116 | Europe | TMC125 | Tibotec Pharmaceuticals, Ireland | HIV Infection | | 06/06 | | |
NCT00412646: TMC125-C203: Phase II Randomized (Patients Are Assigned Different Treatments Based on Chance), Placebo Controlled Dose Escalating Trial of TMC125 in HIV-1 Infected Patients |
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| Completed | 2 | 260 | Europe | TMC125 | Tibotec Pharmaceuticals, Ireland | Anti-Retroviral Agents, HIV-1 | | 11/06 | | |
NCT00111280: TMC125-C211: Trial of TMC125 in HIV-1 Infected Subjects Who Were in a Sponsor Selected TMC125 Trial |
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| Completed | 2 | 48 | US, Europe | TMC125 | Tibotec Pharmaceuticals, Ireland | HIV Infection | | 03/07 | | |
| Completed | 2 | 103 | Europe | raltegravir potassium, Isentress, darunavir/ritonavir, Prezista, etravirine, TMC125, Optimized background regimen, OBT, enfuvirtide | French National Agency for Research on AIDS and Viral Hepatitis, Merck Sharp & Dohme LLC, Janssen-Cilag Tibotec | HIV Infections | 03/08 | 09/09 | | |
NCT00534352: A Study to Evaluate the Pharmacokinetic Profile (How the Body Absorbs, Distributes, Metabolizes and Eliminates a Drug) of TMC125 Plus Tenofovir/Emtricitabine Once Daily With or Without Darunavir/r Once Daily in Antiretroviral (ARV) Naive HIV-1 Patients (Patients Have Never Received ARV Treatment). |
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| Completed | 2 | 23 | US | TMC125; darunavir; ritonavir | Tibotec, Inc, Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA | HIV-1 Infection | 05/08 | 03/09 | | |
NCT00128830 / 2005-000712-27: A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study |
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| Completed | 2 | 211 | US, Europe | Etravirine (ETR), TMC125, Nucleotide reverse transcriptase inhibitors (NRTIs), Protease inhibitors (PIs), Enfuvirtide (ENF) | Tibotec Pharmaceuticals, Ireland | Human Immunodeficiency Virus Type 1 | 08/08 | 08/08 | | |
2010-021651-79: Studio degli effetti immuno-virologici dell’interruzione di Maraviroc nei pazienti che stanno fallendo un regime contenente Maraviroc Viro-Immunologic Effects of Interrupting Maraviroc in Patients Failing a Maraviroc-containing Antiretroviral Treatment (The Maraviroc Short-Stop Study) |
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| Terminated | 2 | 30 | Europe | Coated tablet, Capsule, hard, Film-coated tablet, Gastro-resistant capsule, hard, Tablet, Capsule, soft, CELSENTRI*60CPR RIV 150MG, EMTRIVA*1FL 30CPS 200MG, COMBIVIR*60CPR RIV 150MG+300MG, CELSENTRI*60CPR RIV 300MG, CELSENTRI*90CPR RIV 300MG, ATRIPLA*30CPR RIV600+200+245MG, EPIVIR*BLIST 30CPR RIV 300MG, KIVEXA*FL 30CPR RIV 600MG+300M, RETROVIR*60CPR 300MG, TRUVADA*30CPR RIV 200MG/245MG, VIDEX*30CPS GASTR 400MG, VIREAD*30CPR 245MG, ZERIT*56CPS 30MG, ZERIT*56CPS 40MG, INTELENCE*FL 120CPR 100MG, ZIAGEN*6BLISTER 10CPR 300MG, VIRAMUNE*60CPR 200MG, SUSTIVA*30CPR RIV 600MG BLIST, APTIVUS*FL 120CPS MOLLI 250MG, INVIRASE*FL 120CPR RIV 500MG, KALETRA*120CPR RIV 200MG+50MG, PREZISTA*120CPR RIV 300MG, REYATAZ*FL 60CPS 200MG, NORVIR*4FL 84CPS MOLLI 100MG, TELZIR*1FL 60CPR RIV 700MG, ISENTRESS*FL 60CPR RIV 400MG | FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR | patients affected by HIV in stable treatment with Maraviroc from at least 6 months pazienti adulti affetti da HIV in terapia stabile con Maraviroc da almeno 6 mesi, Diseases [C] - Virus Diseases [C02] | | | | |
NCT00665847 / 2007-007086-21: TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents |
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| Completed | 2 | 103 | US, Canada, Europe, RoW | Etravirine (TMC125), Optimized background regimen (OBR) | Tibotec Pharmaceuticals, Ireland | HIV-1 | 05/11 | 08/11 | | |
NCT00896051 / 2009-010887-41: TMC125-TiDP2-C238: An Exploratory Pharmacokinetics, Safety and Anti-HIV Activity Study of Etravirine (ETR) When Given With Boosted Atazanavir (ATV/Rtv) at Two Different Doses and 1 Nucleoside Reverse Transcriptase Inhibitor (NRTI) in Treatment Experienced HIV Patients |
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| Completed | 2 | 50 | US, Europe, RoW | Atazanavir (ATV) 300 mg, Atazanavir (ATV) 400 mg, Ritonavir (rtv) 100 mg, Nucleo(side)/(tide) reverse transcriptase inhibitors (NRTIs), Etravirine (ETR) 200 mg, Tenofovir disoproxil fumarate (TDF) 300 mg | Janssen R&D Ireland | HIV Infections, Acquired Immunodeficiency Syndrome | 04/12 | 04/12 | | |
INROADS, NCT01199939: A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients |
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| Completed | 2 | 54 | US | Etravirine, Ritonavir, Darunavir | Tibotec, Inc, Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA | Human Immunodeficiency Virus (HIV) | 10/12 | 10/12 | | |
NCT01254656 / 2010-020860-39: A Long Term Safety Study Of Lersivirine For The Treatment Of HIV-1 Infection In Subjects Who Have Completed Treatment With Lersivirine In Studies A5271015 And A5271022 |
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| Terminated | 2 | 108 | Canada, Europe, RoW | lersivirine, efavirenz, etravirine | Pfizer, ViiV Healthcare | HIV-1 | 04/13 | 04/13 | | |
NCT00959894: Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection |
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| Completed | 2 | 80 | US | Etravirine (Intelence), TMC-125, Intelence, Truvada, Tenofovir/emtricitabine | University of North Carolina, Chapel Hill, Janssen Pharmaceuticals | HIV Infections | 02/14 | 05/14 | | |
2005-003841-14: A pilot evaluation of the pharmacokinetic and safety characteristics of TMC114/ritonavir and TMC125 co-administered to HIV-1-infected subjects with limited treatment options |
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| Ongoing | 2 | 10 | Europe | TMC125, TMC114, Norvir, TMC125, TMC114, n/a, Norvir, Norvir | St Stephens AIDS Trust | HIV | | | | |
2004-001657-29: A Phase II, randomized, active controlled, open label trial to investigate the efficacy and tolerability of TMC125 in HIV-1 infected subjects, who are PI-naïve and with documented genotypic evidence of NNRTI resistance from previous NNRTI use.A sub-study of TMC125-C227 to evaluate the pharmacokinetic profile at baseline and at week 4 of TMC125 administered in addition to 2 investigators-selected NRTIs (vers. 3.0, 26 sept 2005) |
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| Ongoing | 2 | 12 | Europe | TMC125, TMC125 (TF035), TMC125 (spray dry formulation - F060), | Tibotec Pharmaceuticals Limited | HIV-1 infection | | | | |
2010-018532-40: A Phase 2b study to select a once daily oral dose of GSK2248761 in HIV-1 infected antiretroviral therapy experienced adults with non-nucleoside reverse transcriptaseinhibitor (NNRTI) resistance |
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| | 2 | 30 | Europe | GSK2248761, GSK2248761, Intelence, Intelence | ViiV Healthcare UK Ltd, Laboratorios ViiV Healthcare SL | HIV-1 infected antiretroviral therapy experienced adult subjects | | 07/11 | | |
NCT02212379 / 2014-000828-24: Capacity of the Dual Combination Raltegravir/Etravirine to Maintain Virological Success in HIV-1 Infected Patients of at Least 45 Years of Age- ANRS 163 ETRAL |
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| Completed | 2 | 170 | Europe | raltegravir and etravirine | ANRS, Emerging Infectious Diseases, Merck Sharp & Dohme LLC, Janssen-Cilag Ltd. | HIV-1 Infection | 10/17 | 04/18 | | |
2019-002618-38: Clinical trial - phase II - to test safety and efficay of Etravirine's treatment in Friedreich Studio clinico di fase II per testare sicurezza ed efficacia del trattamento con Etravirina in pazienti con Atassia di Friedreich |
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| Not yet recruiting | 2 | 35 | Europe | INTELENCE, [J05AG04], Tablet, INTELENCE - 200 MG - COMPRESSA -USO ORALE - FLACONE (HDPE) 60 COMPRESSE | ASSOCIAZIONE "LA NOSTRA FAMIGLIA" - SEZIONE SCIENTIFICA I.R.C.C.S. "E.MEDEA", aCHAF Association, Associazione italiana per la lotta alle sindromi atassiche (A.I.S.A. Onlus), Babel Family, Associazione "OGNI GIORNO" - per Emma onlus, Associazione "Per il Sorriso di Ilaria-Montebruno-Onlus", Università di Roma “Tor Vergata”, Associazione "Un petalo per Margherita Onlus" | Friedreich's ataxia Atassia di Friedreich, Friedreich's ataxia Atassia di Friedreich, Diseases [C] - Nervous System Diseases [C10] | | | | |
| Completed | 2 | 30 | Europe | Etravirine Tablets | IRCCS Eugenio Medea, University of Rome Tor Vergata | Friedreich Ataxia | 01/23 | 01/23 | | |
| Completed | 1/2 | 26 | US, RoW | Etravirine (ETR) | National Institute of Allergy and Infectious Diseases (NIAID) | HIV Infections | 07/18 | 08/20 | | |
