16 completed, 3 terminated. 19 Phase 2, 1 Phase 1, 1 Phase 3.
By phase and status
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All 19 trials
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Trial Phase Status Sponsor Enrollment Start Updated
Safety and Efficacy of Etravirine in Friedreich Ataxia Patients Etravirine Tablets - Friedreich Ataxia Phase 2 Completed 30 2020-09-17 2024-12-04 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 raltegravir and etravirine - HIV-1 Infection Phase 2 Completed 170 2015-01-01 2026-04-03 Evaluating the Safety and Tolerability of Etravirine in HIV-1 Infected Infants and Children Etravirine (ETR) - HIV Infections Phase 1 / Phase 2 Completed 26 2013-03-14 2021-11-02 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 lersivirine, efavirenz, etravirine - HIV-1 Phase 2 Terminated 108 2011-02-01 2014-06-09 Dose-finding Study of GSK2248761 in Antiretroviral Therapy-experienced Subjects With NNRTI-resistant HIV Infection GSK2248761 100 mg once daily, GSK2248761 200 mg once daily, Etravirine - Infection, Human Immunodeficiency Virus Phase 2 Terminated 30 2010-10-05 2017-11-17 A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients Etravirine, Ritonavir, Darunavir - Human Immunodeficiency Virus (HIV) Phase 2 Completed 54 2010-05-01 2013-12-04 Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection Etravirine (Intelence), Truvada - HIV Infections Phase 2 Completed 80 2009-09-01 2016-06-06 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 Atazanavir (ATV) 300 mg, Atazanavir (ATV) 400 mg, Ritonavir (rtv) 100 mg - HIV Infections, Acquired Immunodeficiency Syndrome Phase 2 Completed 50 2009-08-01 2013-09-30 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 etravirine (ETR, TMC125), efavirenz (EFV) - HIV Infection, HIV Phase 2 Completed 157 2009-06-01 2013-01-14 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 UK-453,061 Dose 1, UK-453,061 Dose 2, Etravirine - HIV-1 Phase 2 Terminated 105 2009-03-25 2018-12-04 TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents Etravirine (TMC125), Optimized background regimen (OBR) - HIV-1 Phase 2 Completed 103 2008-11-01 2015-04-23 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). TMC125; darunavir; ritonavir - HIV-1 Infection Phase 2 Completed 23 2008-01-01 2015-04-16 Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses raltegravir potassium, darunavir/ritonavir, etravirine - HIV Infections Phase 2 Completed 103 2007-05-01 2010-09-17 Clinical Trial of CNS-targeted HAART (CIT2) FDA Approved Antiretroviral Therapy (see list below) - HIV Infections Phase 2 / Phase 3 Completed 59 2007-03-01 2014-04-23 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 Etravirine (ETR), Nucleotide reverse transcriptase inhibitors (NRTIs), Protease inhibitors (PIs) - Human Immunodeficiency Virus Type 1 Phase 2 Completed 211 2005-06-01 2013-06-20 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 TMC125 - HIV Infection Phase 2 Completed 116 2005-03-01 2011-05-19 TMC125-C211: Trial of TMC125 in HIV-1 Infected Subjects Who Were in a Sponsor Selected TMC125 Trial TMC125 - HIV Infection Phase 2 Completed 48 2004-09-01 2011-05-19 TMC125-C223: TMC125 in HIV-1 Infected Subjects TMC125 - HIV Infection Phase 2 Completed 211 2004-03-01 2010-04-28 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 TMC125 - Anti-Retroviral Agents, HIV-1 Phase 2 Completed 260 2002-06-01 2010-04-28
Conditions studied HIV Infections (10) · Acquired Immunodeficiency Syndrome (7) · Infections (2) · AIDS Dementia Complex (1) · Cognitive Dysfunction (1) · Friedreich Ataxia (1)
Sponsors Tibotec Pharmaceuticals, Ireland (6) · Pfizer (2) · Tibotec, Inc (2) · ANRS, Emerging Infectious Diseases (1) · French National Agency for Research on AIDS and Viral Hepatitis (1) · IRCCS Eugenio Medea (1) · Janssen R&D Ireland (1) · Janssen-Cilag International NV (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · University of California, San Diego (1) · University of North Carolina, Chapel Hill (1) · ViiV Healthcare (1)
Countries United States (8) · France (5) · South Africa (5) · Brazil (4) · Italy (4) · Spain (4) · United Kingdom (4) · Canada (3) · Puerto Rico (3) · Romania (3) · Argentina (2) · Germany (2) · Poland (2) · Portugal (2) · Switzerland (2)
Top investigators Christine Katlama, MD (1) · Dominique Costagliola, PhD (1) · Jacques Reynes, MD (1) · Michelle Floris-Moore, MD, MS (1) · Richard Rutstein, MD (1) · Ronald J Ellis, MD, PhD (1)
Results publications PMID 18764771 , PMID 18795960 , PMID 19114852 , PMID 20710052 , PMID 21150563 , PMID 21881478 , PMID 22210755 , PMID 24352352 , PMID 25585528 , PMID 26263403 , PMID 26566161 , PMID 39201893
NIH funding 2008 (1) , 2014 (1) , 2019 (1) , R01MH058076 (1)