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Clinical trials for Integrase inhibitors

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 ).  
     
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    24 result(s) found for: Integrase inhibitors. Displaying page 1 of 2.
    1  2  Next»
    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: 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: 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: 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: 2008-003364-19 Sponsor Protocol Number: AI424376 Start Date*: 2009-01-09
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Multicenter, Randomized, Open-Label, Active-Controlled Pilot Study to Evaluate the Safety and Antiretroviral Activity of Unboosted Atazanavir BID Plus Raltegravir BID and Boosted Atazanavir QD in...
    Medical condition: HIV, COMBINATION THERAPY
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020161 HIV infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2007-004736-23 Sponsor Protocol Number: GS-US-183-0130 Start Date*: 2015-02-18
    Sponsor Name:Gilead Sciences Inc.
    Full Title: A Phase 2, Open-Label, Multicenter Study of the Safety of Ritonavir-Boosted GS-9137 (GS-9137/r) Administered in Combination with Other Antiretroviral Agents for the Treatment of HIV-1 Infected Subj...
    Medical condition: Human Immunodeficiency Virus (HIV-1) Infection
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-000151-10 Sponsor Protocol Number: TAR-PRO Start Date*: 2017-08-02
    Sponsor Name:Fundación para la Investigación Biomédica del Hospital Universitario La Paz
    Full Title: Antiretroviral therapy proviral genotype-guided: pilot-proof of concept clinical trial.
    Medical condition: Human Immunodeficiency Virus
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (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
    EudraCT Number: 2009-017951-87 Sponsor Protocol Number: ING112574 Start Date*: 2011-06-28
    Sponsor Name:Viiv Healthcare
    Full Title: A Phase III study to demonstrate the antiviral activity and safety of dolutegravir in HIV-1-infected adult subjects with treatment failure on an integrase inhibitor containing regimen.
    Medical condition: HIV-1-infected adult subjects with treatment failure on an integrase inhibitor containing regimen
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10008922 Chronic infection with HIV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) PT (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-004420-35 Sponsor Protocol Number: GS-US-104-0423 Start Date*: 2013-02-13
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects
    Medical condition: Human Immunodeficiency Virus-1 (HIV-1) Infections
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) ES (Completed) GB (Completed) AT (Completed) NL (Completed) IT (Completed) IE (Completed) PT (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2013-003197-27 Sponsor Protocol Number: RC13_0230 Start Date*: 2013-11-22
    Sponsor Name:CHU de Nantes
    Full Title: Phase 2 multicentric open-label study of switch from abacavir/lamivudine fixed dose combination plus nevirapine to abacavir/lamivudine/dolutegravir in virologically suppressed HIV-1 infected adults
    Medical condition: HIV-1 infection
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2017-004160-35 Sponsor Protocol Number: ISR-003 Start Date*: 2018-03-13
    Sponsor Name:Immune System Regulation AB (ISR)
    Full Title: A prospective, randomised, controlled, parallel arm, open phase IIa study on the efficacy and safety of the GnRH analogue triptorelin for HIV-1 reservoir reduction in HIV-1 infected male adult pati...
    Medical condition: HIV-1 infection
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: SE (Ongoing) DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-000799-32 Sponsor Protocol Number: PROTEST Start Date*: 2011-06-08
    Sponsor Name:Fundació Lluita contra la SIDA
    Full Title: Use of genotypic HIV-1 tropism testing in proviral DNA to guide CCR5 antagonist treatment in subjects with undetectable HIV-1 viremia
    Medical condition: Human immunodeficiency virus (HIV) infection.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10008922 Chronic infection with HIV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-003430-85 Sponsor Protocol Number: OBERAL Start Date*: 2017-11-29
    Sponsor Name:Helsinki University Hospital
    Full Title: A randomized, open, parallel design study to evaluate the effect on liver fat, adipose tissue and metabolic parameters when switching a protease inhibitor or efavirenz to once daily raltegravir in ...
    Medical condition: Study subjects are HIV infected patients with BMI>25kg/m2 and who have at least one metabolic syndrome component or a fatty liver disease.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2019-003614-14 Sponsor Protocol Number: RAINBOW Start Date*: 2019-12-16
    Sponsor Name:ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    Full Title: Feasibility, efficacy and safety of rapid (within 7 days from HIV diagnosis) antiretroviral initiation strategy based on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in HIV-infected na...
    Medical condition: HIV infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10020441 Human immunodeficiency virus infection, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-000274-35 Sponsor Protocol Number: DOLAM Start Date*: 2015-04-23
    Sponsor Name:FUNDACIÓ CLÍNIC PER A LA RECERCA BIOMÈDICA
    Full Title: An open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of two dolutegravir-based simplification strategies in HIV-infected patients with prolonged viro...
    Medical condition: Infection with human immunodeficiency virus (HIV).
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10008919 Chronic HIV infection LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2007-005854-21 Sponsor Protocol Number: RDEA806-201 Start Date*: 2008-01-15
    Sponsor Name:Ardea Biosciences Inc.
    Full Title: A multicenter Phase 2a, randomized, double-blind, placebo-controlled, proof-of-concept trial to determine the antiviral activity, pharmacokinetics, tolerability and safety of RDEA806 in HIV-1 posit...
    Medical condition: HIV-1
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020161 HIV infection LLT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed) GB (Completed) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-004483-30 Sponsor Protocol Number: GS-US-236-0115 Start Date*: 2012-01-20
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3b Randomized, Open Label Study to Evaluate Switching from Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI/r) plus Emtricitabine/Tenofovir Fixed-Dose Combination (FTC/TDF)...
    Medical condition: Human Immunodeficiency Virus (HIV-1) Infections
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10068341 HIV-1 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) ES (Completed) AT (Completed) PT (Completed) GB (Completed) IT (Completed)
    Trial results: View results
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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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