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Clinical trials for Integrase

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    63 result(s) found for: Integrase. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2014-003710-84 Sponsor Protocol Number: CIIS Start Date*: 2014-11-27
    Sponsor Name:Imperial College London
    Full Title: The Central Nervous System Effects of Two Different HIV-Integrase Inhibitor Containing Antiretroviral Regimens.
    Medical condition: Human Immunodificiency Virus
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-000087-42 Sponsor Protocol Number: TAISTR_2016 Start Date*: 2016-05-11
    Sponsor Name:University College Dublin
    Full Title: A multicentre, prospective, single arm, open-label 96 week observational trial of the tolerability, adherence and efficacy of a dolutegravir/abacavir/lamivudine single tablet regimen in HIV-1 antib...
    Medical condition: Human Immunodeficiency Virus (HIV) infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Prematurely Ended) ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-001206-33 Sponsor Protocol Number: 1-28/08/2014 Start Date*: 2015-07-07
    Sponsor Name:OSPEDALE SAN RAFFAELE
    Full Title: A pilot phase II study of a nucleoside sparing regimen of Dolutegravir + Atazanavir/r in HIV-1 infected patients with detectable viremia (Dolatav Study)
    Medical condition: HIV-1 infected patients
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10008922 Chronic infection with HIV LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-003481-13 Sponsor Protocol Number: NEAT44 Start Date*: 2019-01-15
    Sponsor Name:NEAT ID Foundation
    Full Title: An Open-Label, Multi-Centre, Randomised Study to Investigate Integrase Inhibitor Versus Boosted Protease Inhibitor Antiretroviral Therapy for Patients with Advanced HIV Disease. The Late Presenter ...
    Medical condition: Patients who present late on during their acquisition of the HIV-1 (Human Immunodeficiency Virus)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10020192 HIV-1 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Trial now transitioned) DE (Ongoing) ES (Ongoing) BE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-018001-51 Sponsor Protocol Number: ING111762 Start Date*: 2010-11-10
    Sponsor Name:Viiv Healthcare S. L
    Full Title: Estudio de Fase III aleatorizado, doble ciego, para evaluar la seguridad y eficacia de 50 mg una vez al día de GSK1349572 frente a 400 mg dos veces al día de Raltegravir, ambos administrados en com...
    Medical condition: Sujetos adultos infectados por el VIH-1, que han recibido tratamiento antirretroviral previo con la excepción de un inhibidor de la integrasa.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10008922 Chronic infection with HIV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) FR (Completed) BE (Completed) NL (Completed) GB (GB - no longer in EU/EEA) GR (Completed) IT (Completed) HU (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2009-014602-33 Sponsor Protocol Number: CH-2009.01 Start Date*: 2010-06-03
    Sponsor Name:Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer
    Full Title: IMPACT D’UNE INTENSIFICATION THERAPEUTIQUE PAR INHIBITEUR D’INTEGRASE +/- INHIBITEUR DE CCR5 SUR LE RESERVOIR LYMPHOÏDE DU VIH-1 CHEZ DES PATIENTS AU STADE CHRONIQUE DE L’INFECTION
    Medical condition: Infection à VIH-1
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-012283-14 Sponsor Protocol Number: SECOND-LINE Start Date*: 2010-08-16
    Sponsor Name:National Centre in HIV Epidemiology and Clinical Research
    Full Title: A randomised open‐label study comparing the safety and efficacy of ritonavir boosted lopinavir and 2‐3N(t)RTI backbone versus ritonavir boosted lopinavir and raltegravir in participants virological...
    Medical condition: Chronic HIV infection
    Disease: Version SOC Term Classification Code Term Level
    12.0 10008919 Chronic HIV infection LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IE (Completed) FR (Ongoing) GB (Completed) DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-015904-24 Sponsor Protocol Number: UKB-2009-MED-I-JKR-01 Start Date*: 2010-10-20
    Sponsor Name:Rheinische Friedrich-Wilhelms-Universität Bonn
    Full Title: An open, prospective study to compare the safety and efficacy of raltegravir vs. atazanavir / ritonavir, both in combination with tenofovir DF and emtricitabine, in the treatment of HIV-infection i...
    Medical condition: HIV disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-004732-30 Sponsor Protocol Number: 257865 Start Date*: 2019-06-28
    Sponsor Name:University of Sussex
    Full Title: A Phase IV, Randomised, Open-Label Pilot Study to Evaluate Switching from Protease-Inhibitor based regimen to Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in Integrase Inhi...
    Medical condition: Human Immunodeficiency Virus
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10008919 Chronic HIV infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2019-002843-81 Sponsor Protocol Number: 057 Start Date*: 2020-01-07
    Sponsor Name:IMEA
    Full Title: Switch to Tenofovir Alafenamide (TAF), Emtricitabine (FTC), Bictegravir (BIC)(Biktarvy®) in HIV-1-infected patients over 65 years old at risk of polymedication
    Medical condition: HIV-1-infected patient Age > 65 years old Plasma HIV RNA ≤ 50 copies/mL for ≥ 6 months: one blip between 50 et 200 cp/ml is allowed in the last 6 months before screening. Currently receiving an ant...
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-004578-40 Sponsor Protocol Number: SSAT066 Start Date*: 2015-01-26
    Sponsor Name:St Stephen's AIDS Trust
    Full Title: A phase IV, open-label three-arm study investigating the impact of a combination of tenofovir disoproxil fumarate/emtricitabine with raltegravir or dolutegravir or elvitegravir/cobicistat on renal ...
    Medical condition: HIV
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-001476-37 Sponsor Protocol Number: PENTA17 Start Date*: 2015-12-16
    Sponsor Name:Fondazione PENTA ONLUS
    Full Title: SMILE: Strategy for Maintenance of HIV suppression with elvitegravir+darunavir/ritonavir in children (PENTA 17) - A two-arm, Phase 2/3 multicentre, open-label, randomised study evaluating safety ...
    Medical condition: Paediatric HIV-1 Infection
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10068341 HIV-1 infection LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) PT (Completed) GB (GB - no longer in EU/EEA) BE (Completed) DE (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-001646-16 Sponsor Protocol Number: ING114916 Start Date*: 2012-10-16
    Sponsor Name:ViiV Healthcare UK Limited
    Full Title: A Dolutegravir Open Label Protocol for HIV infected, Adult and Adolescents Patients with Integrase Resistance
    Medical condition: Treatment of Human Immunodeficiency Virus (HIV) infection in patients with raltegravir (RAL) or elvitegravir (ELV) resistance who have limited treatment options.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10020194 HIV-2 infection LLT
    14.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) IT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-004241-32 Sponsor Protocol Number: EDOLAS Start Date*: 2020-02-07
    Sponsor Name:SOCIETA' ITALIANA MALATTIE INFETTIVE E TROPICALI
    Full Title: Efficacy and safety of early switching to dolutegravir/lamivudine (DTG/3TC) from INSTI-based three-drug regimens in HIV-1-infected adults previously naïve who achieve virological suppression
    Medical condition: HIV-1 infected individuals currently taking an INSTI-based three-drug first-line regimen for less than 18 months and who have been virologically suppressed with HIV-1 RNA <50 copies/mL
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-000728-18 Sponsor Protocol Number: VT002 Start Date*: 2005-02-21
    Sponsor Name:AISAR ASSOCIAZIONE ITALIANA PER LO STUDIO DEGLI ANTIMICROBICI E DELLE RESISTENZE
    Full Title: An experiment of phase II open label about safety and Mifepristone vgx-410 anti-HIV activity on patients affected by HIV-1
    Medical condition: Anti-HIV drug
    Disease: Version SOC Term Classification Code Term Level
    10000807 PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004007-12 Sponsor Protocol Number: 066VER Start Date*: 2020-06-02
    Sponsor Name:University of Sussex
    Full Title: Brain connectivity and patient reported outcomes in people with HIV (PWH) with symptoms of insomnia switching integrase inhibitor-based ART; a randomised controlled study
    Medical condition: HIV infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-000302-39 Sponsor Protocol Number: IN-ES-380-4475 Start Date*: 2018-06-18
    Sponsor Name:Fundació Lluita contra la SIDA
    Full Title: Bictegravir concentrations and antiviral activity in cerebrospinal fluid in HIV-1 Infected individuals
    Medical condition: HIV-1 infected individuals
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-003921-27 Sponsor Protocol Number: DORAGEN Start Date*: 2019-06-25
    Sponsor Name:Lluita contra la SIDA Foundation
    Full Title: Doravirine concentrations and antiviral activity in genital fluids in HIV-1 infected individuals.
    Medical condition: HIV infected individuals
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2020-001103-17 Sponsor Protocol Number: INSTI01 Start Date*: 2021-01-11
    Sponsor Name:Cliniques universitaires Saint-Luc
    Full Title: Gut microbiota, pharmacogenetics and Integrase Strand Transfer Inhibitors response
    Medical condition: HIV infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-001866-15 Sponsor Protocol Number: 1182.71 Start Date*: 2007-07-12
    Sponsor Name:Boehringer Ingelheim France SAS
    Full Title: A prospective randomized, open-labelled, multi-centre trial comparing the safety and efficacy of Ritonavir-boosted Aptivus (Tipranavir, TPV/r) to that of Prezista® (Darunavir, DRV/r) in three-clas...
    Medical condition: HIV infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) ES (Completed) DE (Prematurely Ended) GR (Completed) PT (Prematurely Ended) IT (Prematurely Ended) BE (Completed)
    Trial results: View results
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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