Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Cabotegravir

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   44336   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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    9 result(s) found for: Cabotegravir. Displaying page 1 of 1.
    EudraCT Number: 2021-006779-41 Sponsor Protocol Number: CAR-GR Start Date*: 2022-10-26
    Sponsor Name:FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA
    Full Title: HIV-1 RNA suppression and drug concentrations in semen, cervicovaginal fluid and rectum in HIV-1 infected individuals receiving intramuscular long-acting cabotegravir plus rilpivirine (“CAR-GR Study)
    Medical condition: HIV infected individuals
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2023-001064-26 Sponsor Protocol Number: TMC278LAHTX4002 Start Date*: 2024-05-24
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 4, Open-Label, Rollover Study to Provide Continued Access to Cabotegravir Long-acting Injection and Rilpivirine Long-acting Injection to Participants Living with Human Immunodeficiency Viru...
    Medical condition: Human Immunodeficiency Virus 1
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10020443 Human immunodeficiency virus syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2020-000424-19 Sponsor Protocol Number: 213199 Start Date*: 2020-09-07
    Sponsor Name:Viiv Healthcare UK Limited
    Full Title: A Phase IIIb, open-label, hybrid type III trial evaluating implementation strategies for long-acting cabotegravir plus long-acting rilpivirine every two months in HIV-1 infected, virologically su...
    Medical condition: Human Immunodeficiency Virus Type 1 (HIV-1)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10003582 Asymptomatic human immunodeficiency virus type I infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) NL (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2017-002946-62 Sponsor Protocol Number: 207966 Start Date*: 2017-09-18
    Sponsor Name:ViiV Healthcare, S.L.
    Full Title: A Phase IIIb, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine A...
    Medical condition: Human Immunodeficiency Virus type 1 (HIV-1)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000020183 10003582 Asymptomatic human immunodeficiency virus type I infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) SE (Ongoing) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-001647-39 Sponsor Protocol Number: 201585 Start Date*: 2016-10-20
    Sponsor Name:ViiV Healthcare, S.L.
    Full Title: A Phase III, randomized, multicenter, parallel-group, noninferiority, open-label study evaluating the efficacy, safety, and tolerability of switching to long-acting cabotegravir plus longacting ril...
    Medical condition: Human Immunodeficiency Virus type 1 (HIV-1)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10003582 Asymptomatic human immunodeficiency virus type I infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) SE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-001646-25 Sponsor Protocol Number: 201584 Start Date*: 2016-10-20
    Sponsor Name:ViiV Healthcare, S.L.
    Full Title: A Phase III, Randomized, Multicenter, Parallel-group, Open- Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance o...
    Medical condition: Human Immunodeficiency Virus type 1 (HIV-1)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10003582 Asymptomatic human immunodeficiency virus type I infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (GB - no longer in EU/EEA) DE (Completed) NL (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-002623-11 Sponsor Protocol Number: 213500 Start Date*: 2020-12-18
    Sponsor Name:ViiV Healthcare UK Limited
    Full Title: A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravi...
    Medical condition: Human Immunodeficiency Virus Type-1 (HIV-1)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10003582 Asymptomatic human immunodeficiency virus type I infection LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed) NL (Completed) GB (GB - no longer in EU/EEA) IE (Completed) DE (Completed) AT (Completed) IT (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2013-000783-29 Sponsor Protocol Number: 200056 Start Date*: 2014-05-21
    Sponsor Name:ViiV Healthcare UK Limited
    Full Title: A Phase IIb Study Evaluating a Long-Acting Intramuscular Regimen of GSK1265744 plus TMC278 For The Maintenance of Virologic Suppression Following an Induction of Virologic Suppression on an Oral re...
    Medical condition: HIV-1-infected adult participants
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10008922 Chronic infection with HIV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2008-006158-16 Sponsor Protocol Number: UMCN-AKF08.02 Start Date*: 2009-02-13
    Sponsor Name:Radboud university medical center
    Full Title: Study on Pharmacokinetics of newly developed ANtiretroviral agents in HIV-infected pregNAnt women (PANNA)
    Medical condition: HIV-infection in pregnant women
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000020173 10020175 HIV infection with other conditions LLT
    Population Age: Newborns, Infants and toddlers, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) ES (Ongoing) GB (GB - no longer in EU/EEA) DE (Trial now transitioned) IE (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    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.
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu May 15 09:37:59 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA