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Clinical trials for Dolutegravir

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
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    • 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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    99 result(s) found for: Dolutegravir. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    EudraCT Number: 2018-004885-32 Sponsor Protocol Number: DOBINeuro Start Date*: 2019-08-30
    Sponsor Name:AZIENDA OSPEDALIERA UNIVERSITARIA SENESE
    Full Title: THE EFFECTS OF SWITCHING FROM DOLUTEGRAVIR/LAMIVUDINE/ABACAVIR (D/L/A) TO BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE (B/F/TAF) IN PATIENTS WITH SUPPRESSED VIRAL LOAD ON NEUROPSYCHIATRIC SIDE E...
    Medical condition: HIV-1 infection
    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 (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003243-36 Sponsor Protocol Number: VIDEOS Start Date*: 2014-01-08
    Sponsor Name:Unidad de VIH - Servicio de Enfermedades Infecciosas. Hospital de Bellvitge
    Full Title: Dolutegravir HIV-1 viral decay and pharmacokinetics in semen in ARV-naïve patients initiating Abacavir/Lamivudine plus Dolutegravir.
    Medical condition: HIV-1 infection
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-004488-19 Sponsor Protocol Number: UMCN-AKF-14.08 Start Date*: 2015-07-23
    Sponsor Name:Radboud University Medical Center
    Full Title: Pharmacokinetics, safety and efficacy of atazanavir /dolutegravir/lamivudine regimen as maintenance regimen in pa-tients with intolerance and/or resistance to NRTIs, NNRTIs and RTV: a pilot study (...
    Medical condition: HIV
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-004999-19 Sponsor Protocol Number: 191001 Start Date*: 2020-06-16
    Sponsor Name:Department of infectious diseases, Hvidovre Hospital
    Full Title: Changes in weight, body composition and metabolic parameters after switch to dolutegravir/lamuvidine compared to continued treatment with dolutegravir/abacavir/lamuvidine for virologically suppress...
    Medical condition: Human immunodeficiency viruses (HIV)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10067326 Antiretroviral therapy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2019-000800-14 Sponsor Protocol Number: FIS-TAR-01-2019 Start Date*: 2020-02-07
    Sponsor Name:Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)
    Full Title: Effectiveness of a dual therapy based on dolutegravir plus lamivudine on reduction of the viral reservoir, immune recovery and immune activation compared with a triple antiretroviral therapy based ...
    Medical condition: Adult patients with HIV infection without previous treatment
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10020161 HIV infection PT
    20.1 10021881 - Infections and infestations 10020160 HIV disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000856-16 Sponsor Protocol Number: DTG_HD Start Date*: 2015-05-27
    Sponsor Name:Fundació Lluita contra la SIDA
    Full Title: Removal of dolutegravir by hemodialysis in HIV-infected patients with end-stage renal disease.
    Medical condition: HIV-infected patients with end-stage renal disease
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004862 10068341 HIV-1 infection LLT
    17.1 100000004857 10014646 End stage renal disease (ESRD) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2013-000547-85 Sponsor Protocol Number: OSTEODOLU Start Date*: 2013-09-03
    Sponsor Name:Fundació Lluita contra la SIDA
    Full Title: MULTICENTRE STUDY TO ASSESS CHANGES IN BONE MINERAL DENSITY OF THE SWITCH FROM PROTEASE INHIBITORS TO DOLUTEGRAVIR IN HIV-1-INFECTED SUBJECTS WITH LOW BONE MINERAL DENSITY
    Medical condition: HIV-infected patients with low bone mineral density
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004862 10020175 HIV infection with other conditions LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-000469-62 Sponsor Protocol Number: 2017-000469-62 Start Date*: 2017-07-24
    Sponsor Name:Fundació Clínic per a la Recerca Biomèdica
    Full Title: Pilot single‐arm clinical trial to evaluate the efficacy, PK interactions and safety of dolutegravir plus 2 NRTIs in HIV‐1‐infected solid organ transplant patients
    Medical condition: HIV-1 infected solid organ transplant patients
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10068341 HIV-1 infection LLT
    20.0 10022891 - Investigations 10057925 Transplant evaluation PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-005454-19 Sponsor Protocol Number: 51858 Start Date*: 2015-03-16
    Sponsor Name:Erasmus MC
    Full Title: The Dolutegravir Antiretroviral Mono-Therapy for HIV Trial
    Medical condition: Evaluation of the efficacy and safety of a switch from cART to dolutegravir monotherapy in HIV
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-000346-61 Sponsor Protocol Number: DTG-01-01 Start Date*: 2017-02-20
    Sponsor Name:Blueclinical, Ltd.
    Full Title: A Phase II, Multicenter, Single-Arm, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of Triple Therapy with Dolutegravir plus 2 NRTIs, in Treatment-Naïve HIV-2 Infected Subjects
    Medical condition: Human immunodeficiency virus (HIV)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10020194 HIV-2 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed)
    Trial results: View results
    EudraCT Number: 2020-000205-89 Sponsor Protocol Number: 01012020 Start Date*: 2020-06-16
    Sponsor Name:Department of Infectious Diseases, Hvidovre Hospital
    Full Title: Changes in weight, body composition and metabolic parameters after switch to either dolutegravir/lamivudine or doravirine/tenofovir/lamivudine compared to continued treatment with dolutegravir/teno...
    Medical condition: Human immunodeficiency virus (HIV)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10067326 Antiretroviral therapy PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-001158-82 Sponsor Protocol Number: GESIDA10418 Start Date*: 2018-09-21
    Sponsor Name:Fundación SEIMC-GESIDA
    Full Title: Phase IV, Open Label, Randomized, Clinical Trial to Evaluate the Reversibility of abacavir/lamivudine/dolutegravir CNS-Related Neurotoxicity After Switching to tenofovir alafenamide/emtricitabine/d...
    Medical condition: HIV
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10001509 AIDS LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2013-003704-39 Sponsor Protocol Number: NEAT22/SSAT060 Start Date*: 2014-04-01
    Sponsor Name:St Stephen's AIDS Trust [...]
    1. St Stephen's AIDS Trust
    2. NEAT-ID
    Full Title: An open label study examining the efficacy and cardiovascular risk of immediate versus deferred switch from a boosted PI to dolutegravir (DTG) in HIV infected patients with stable virological suppr...
    Medical condition: HIV infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) ES (Ongoing) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-003541-17 Sponsor Protocol Number: FIMHCSBR-2017 Start Date*: 2018-10-24
    Sponsor Name:FIMABIS Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud [...]
    1. FIMABIS Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
    2. APES Costa del Sol (Agencia Pública Empresarial Sanitaria)
    Full Title: Neuropsiquiatric Evolution After Introduction of Raltegravir QD in substitution of dolutegravir: NEAR QD Study
    Medical condition: Human Inmunodeficiency Virus Infection (HIV)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004109-28 Sponsor Protocol Number: DOLLARS Start Date*: 2020-01-17
    Sponsor Name:Daniel Podzamczer Palter
    Full Title: HIV-1 RNA decay in semen and rectum and changes in HIV reservoir in rectal tissue in ART-naïve HIV+ men treated with dolutegravir plus lamivudine compared to Bictegravir/FTC/TAF (“DOLLARS study”)
    Medical condition: HIV infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10020161 HIV infection PT
    Population Age: Adults Gender: Male
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-001426-57 Sponsor Protocol Number: Penta21 Start Date*: 2023-04-25
    Sponsor Name:Fondazione Penta Onlus
    Full Title: A randomised non-inferiority trial with nested PK to assess DTG/3TC fixed dose formulations for the maintenance of virological suppression in children with HIV infection aged 2 to <15 years old
    Medical condition: HIV Infection
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    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: 2019-004620-38 Sponsor Protocol Number: DOLU-FAT Start Date*: 2020-04-09
    Sponsor Name:Fundació Lluita contra la SIDA
    Full Title: Study to assess the effect of a Darunavir/Cobicistat-based regimen on weight and body composition in HIV-infected subjects who present weight gain during a dolutegravir-based regimen.
    Medical condition: HIV infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10020161 HIV infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-005927-19 Sponsor Protocol Number: GESIDA11920 Start Date*: 2022-05-17
    Sponsor Name:Fundación SEIMC-GESIDA
    Full Title: Phase IV, randomized, multicenter, double-blind clinical trial designed to evaluate the safety and convenience of switching from Dolutegravir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir alafe...
    Medical condition: Human immunodeficiency virus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10053500 Human immunodeficiency virus transmission PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003988-10 Sponsor Protocol Number: GS-US-380-1490 Start Date*: 2016-02-18
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infec...
    Medical condition: Human Immunodeficiency Virus (HIV-1) Infection
    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: GB (GB - no longer in EU/EEA) BE (Completed) DE (Completed) ES (Completed) FR (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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