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Clinical trials for Bictegravir

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    36 result(s) found for: Bictegravir. Displaying page 1 of 2.
    1  2  Next»
    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: 2018-000302-39 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: 2018-004885-32 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 (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: 2022-000358-26 Sponsor Protocol Number: BETAF-RED Start Date*: 2022-05-11
    Sponsor Name:Institut d’Investigacions Biomèdiques August Pi i Sunyer
    Full Title: Safety, tolerability, and efficacy of a dose reduction strategy based on bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed HIV-infected adults.
    Medical condition: HIV infection
    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: ES (Ongoing)
    Trial results: (No results available)
    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: 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: 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 (Ongoing) DE (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-003458-26 Sponsor Protocol Number: DEBATE Start Date*: 2019-03-25
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
    Full Title: Evaluating inflammatory and immunological changes of HIV-positive patients switching to DTG dual regimen compared to those switching to a triple drugs regimen (B/F/TAF).
    Medical condition: HIV 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: 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)
    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 (Ongoing) DE (Ongoing) IT (Ongoing)
    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: (No results available)
    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 (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-000812-27 Sponsor Protocol Number: 055 Start Date*: 2019-05-09
    Sponsor Name:IMEA
    Full Title: Initiation of first-line antiretroviral treatment with TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the first clinical contact in France: Trial IMEA 055 – FAST
    Medical condition: HIV positive age > 18 years - newly diagnosed HIV-infected individual evidenced by any tests - antiretroviral-treatment naive - negative urine pregnancy test - willing to sign an informed written...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (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: 2021-000436-62 Sponsor Protocol Number: GS-US-380-4547 Start Date*: 2021-02-12
    Sponsor Name:Gilead Sciences, Inc
    Full Title: A Phase 1, Single-Dose, Cross-Over Study Evaluating the Relative Bioavailability and Food Effect of a Pediatric Tablet for Oral Suspension of Bictegravir/Emtricitabine/Tenofovir Alafenamide and the...
    Medical condition: Human Immunodeficiency Virus (HIV-1) Infection
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    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: 2018-003880-79 Sponsor Protocol Number: EBONY Start Date*: 2019-03-15
    Sponsor Name:ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    Full Title: Efficacy and safety of the switch from Efavirenz / emtricitabine / tenofovir difumarate taken once daily or alternate days to Bictegravir / emtricitabine / tenofovir alafenamide in HIV + virologica...
    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 (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-000308-17 Sponsor Protocol Number: GS-US-380-4030 Start Date*: 2017-07-05
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir D...
    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: DE (Completed) AT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-000926-79 Sponsor Protocol Number: GS-US-380-4458 Start Date*: 2018-08-07
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide versus Dolutegravir + Emtricitabine/Tenofo...
    Medical condition: Human Immunodeficiency Virus (HIV-1) Infection Hepatitis B Virus
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10068341 HIV-1 infection LLT
    20.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed) ES (Restarted) GR (Completed)
    Trial results: (No results available)
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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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