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Clinical trials for BIC

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   44334   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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    33 result(s) found for: BIC. Displaying page 1 of 2.
    1  2  Next»
    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: 2020-003686-18 Sponsor Protocol Number: GESIDA11720 Start Date*: 2021-04-29
    Sponsor Name:Seimc-Gesida Foundation
    Full Title: DTG/3TC vs. BIC/FTC/TAF maintenance therapy in people living with HIV: an open-label randomized clinical trial
    Medical condition: HIV
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    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: 2019-000590-23 Sponsor Protocol Number: MK-8591A-020 Start Date*: 2020-03-31
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck &Co.,Inc
    Full Title: A Phase 3 Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir Once-Daily in HIV-1 Infected Treatm...
    Medical condition: HIV-1 infection and naïve to antiretroviral therapy
    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: ES (Ongoing) FR (Completed) DE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-003071-18 Sponsor Protocol Number: MK-8591-013 Start Date*: 2021-02-02
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 2b, Randomized, Active-Controlled, Double-Blind, Dose-Ranging Clinical Study to Evaluate a Switch to Islatravir (ISL) and MK-8507 Once-Weekly in Adults with HIV-1 Virologically Suppressed o...
    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: FR (Trial now transitioned)
    Trial results: View results
    EudraCT Number: 2009-016879-29 Sponsor Protocol Number: IPR/22 Start Date*: 2010-01-25
    Sponsor Name:MOLMED
    Full Title: NGR015: Randomized double-blind phase III study of NGR-hTNF plus best investigator s choice (BIC) versus placebo plus BIC in previously treated patients with advanced malignant pleural mesothelioma...
    Medical condition: Patients with advanced malignant pleural mesothelioma (MPM)previously treated with pemetrexed
    Disease: Version SOC Term Classification Code Term Level
    12.1 10035605 Pleural mesothelioma malignant advanced LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) AT (Completed) IE (Completed) GB (Completed) NL (Completed) BE (Completed) SE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-000685-42 Sponsor Protocol Number: 2DR-study Start Date*: 2020-04-30
    Sponsor Name:Ghent University Hospital
    Full Title: Virological and immunological assessment in HIV positive participants on 2DR versus 3DR in a prospective randomized controlled switch trial.
    Medical condition: human immunodeficiency viruses (HIV)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned)
    Trial results: View results
    EudraCT Number: 2021-004010-19 Sponsor Protocol Number: IMEA064 Start Date*: 2021-10-15
    Sponsor Name:IMEA-Fondation Léon M'Ba
    Full Title: Pharmacokinetics of calcineurin & mTOR inhibitors in HIV-1 infected kidney transplant recipients after switch to BIC/FTC/TAF: a pilot study - KINETIK (KIdNEy Transplant bIKtarvy) IMEA 064
    Medical condition: • HIV-1 infected patients > 18 years • Antiretroviral treatment switch to BIC/FTC/TAF decided in standard care by ID physician • Kidney transplant recipient ≥ 3 months • Receiving calcineurin and/o...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-001073-23 Sponsor Protocol Number: GS-US-380-5310 Start Date*: 2021-03-08
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 1b, Open-label study to Evaluate the PK, Safety and Efficacy of B/F/TAF in HIV-1 infected, Virologically Suppressed, Pregnant Women in their Second and Third Trimesters
    Medical condition: Human Immunodeficiency Virus (HIV-1) Infections
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adults Gender: Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-004871-38 Sponsor Protocol Number: BIFAST Start Date*: 2020-06-03
    Sponsor Name:FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
    Full Title: Phase IV, single-center, open study to assess the benefits of the start of immediate treatment without immunovirological data (“Same Day Treatment”) compared to conventional treatment with BIC / FT...
    Medical condition: HIV infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    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: 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: 2019-003208-11 Sponsor Protocol Number: CRF002 Start Date*: 2020-03-04
    Sponsor Name:Chelsea and Westminster Hospital NHS Foundation Trust
    Full Title: Efficacy of BIC/F/TAF versus standard of care in the treatment of new HIV infection diagnoses in the context of 'test and treat'
    Medical condition: Human Immunodeficiency Virus (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: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2019-000587-23 Sponsor Protocol Number: MK-8591A-018 Start Date*: 2020-01-13
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Bicte...
    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: FI (Completed) ES (Ongoing) FR (Completed) DE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002345-39 Sponsor Protocol Number: GS-US-380-1474 Start Date*: 2016-06-29
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infect...
    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: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2013-002037-38 Sponsor Protocol Number: NL44415.078.13 Start Date*: 2013-10-29
    Sponsor Name:
    Full Title: The effect of correction of metabolic acidosis in chronics kidney disease on intrarenal RAS activity.
    Medical condition: Metabolic acidosis in chronic kidney disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003428-61 Sponsor Protocol Number: GS-US-380-4449 Start Date*: 2018-04-06
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching from an Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed-Dose Combination Regimen or a Tenofovir Disoproxil Fumarate...
    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: Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) ES (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-002310-12 Sponsor Protocol Number: IN-ES-380-4663 Start Date*: 2018-11-19
    Sponsor Name:Fundació Lluita contra la SIDA
    Full Title: Bictegravir concentrations and antiviral activity in genital fluids and rectal compartment in HIV-1 infected individuals (“BIGER Study”).
    Medical condition: HIV-1 infected male and female adults not previously exposed to ART.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-004499-36 Sponsor Protocol Number: VIHOSB Start Date*: 2019-08-07
    Sponsor Name:Consorci Mar Parc de Salut de Barcelona
    Full Title: Study to assess bone health with bone mineral density, bone microarchitecture and bone tissue quality after switching from a TDF regimen to Bictegravir-TAF-FTC
    Medical condition: Bone health (bone mineral density, microarchitecture and bone quality) in HIV individuals under antiretroviral treatment with tenofovir disoproxil fumarate (TDF) that change treatment to bictegravi...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
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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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