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Clinical trials for Antiretroviral drugs

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   44339   clinical trials with a EudraCT protocol, of which   7369   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.
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    165 result(s) found for: Antiretroviral drugs. Displaying page 1 of 9.
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    EudraCT Number: 2005-001372-12 Sponsor Protocol Number: 1100.1426 Start Date*: 2005-11-30
    Sponsor Name:Boehringer Ingelheim Netherlands B.V.
    Full Title: An open-label, non-randomized, single arm study, to investigate the mechanism(s) by which nevirapine increases plasma high density lipoproteins concentration in HIV + subjects treated with Viramune...
    Medical condition: Treatment of HIV infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-003215-66 Sponsor Protocol Number: MARAVITRANS Start Date*: 2012-09-26
    Sponsor Name:FIBio Hospital Universitario Ramón y Cajal
    Full Title: EFFECT OF MARAVIROC ON THE TRANSCRIPTION OF THE HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) IN RESTING CD4+ T LYMPHOCYTES IN PATIENTS ON ANTIRETROVIRAL TREATMENT WITH SUPPRESSED VIRAL LOAD
    Medical condition: HIV-infected patients
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-005270-35 Sponsor Protocol Number: INMI/002/11 Start Date*: 2011-12-07
    Sponsor Name:ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI
    Full Title: HIV-infected pregnant women treated with HAART: registry of pharmacokinetic parameters of new and commonly used antiretrovirals
    Medical condition: HIV-1 infection
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10008922 Chronic infection with HIV LLT
    Population Age: Adults Gender: Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-003425-81 Sponsor Protocol Number: RLBUHT2763 Start Date*: 2007-03-29
    Sponsor Name:University of Liverpool
    Full Title: Host genetic factors influencing drug disposition and response to HIV treatment
    Medical condition: Pharmacogeneric study of HIV+ patients receiving antiretroviral therapy. We wish to correlate drug concentration with host genetic patients receiving certain HIV drugs. No dosage modification will...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-003841-14 Sponsor Protocol Number: SSAT 0012 Start Date*: 2005-09-28
    Sponsor Name:St Stephens AIDS Trust
    Full Title: A pilot evaluation of the pharmacokinetic and safety characteristics of TMC114/ritonavir and TMC125 co-administered to HIV-1-infected subjects with limited treatment options
    Medical condition: HIV
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-000748-14 Sponsor Protocol Number: M06-802 Start Date*: 2006-08-14
    Sponsor Name:Abbott GmbH & Co. KG
    Full Title: A Phase 3, Randomized, Open-label Study of Lopinavir/ritonavir Tablets 800/200 mg Once-daily Versus 400/100 mg Twice-daily when Coadministered with Nucleoside/Nucleotide Reverse Transcriptase Inhib...
    Medical condition: Antiretroviral experienced, HIV-1 Infection. Adequate ICD classification code not available.
    Disease: Version SOC Term Classification Code Term Level
    9.0 10020192 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed) ES (Completed) DE (Completed) IE (Completed) PT (Completed) GR (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-001070-29 Sponsor Protocol Number: CRF005 Start Date*: 2023-05-26
    Sponsor Name:Chelsea and Westminster NHS Foundation Trust
    Full Title: Efficacy, tolerability and acceptability of the single tablet regimen (STR) Biktarvy® by trans people living with HIV (TPLWH)
    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: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-000441-38 Sponsor Protocol Number: CPCRA 065 Start Date*: 2005-04-26
    Sponsor Name:National Institute of Allergy and Infectious Diseases, National Institutes of Health
    Full Title: Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
    Medical condition: HIV infection
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) IT (Prematurely Ended) IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002125-30 Sponsor Protocol Number: AELIX-003 Start Date*: 2019-05-09
    Sponsor Name:AELIX Therapeutics
    Full Title: A Phase IIa, randomized, double-blind, placebo-controlled, study of HIV-1 Vaccines MVA.HTI and ChAdOx1.HTI with TLR7 agonist vesatolimod (GS-9620), in early treated HIV-1 infection
    Medical condition: Human immunodeficiency virus type 1
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10020161 HIV infection PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Restarted)
    Trial results: View results
    EudraCT Number: 2008-003917-29 Sponsor Protocol Number: GS-US-183-0152 Start Date*: 2008-11-11
    Sponsor Name:Gilead Sciences Incorporated
    Full Title: A Phase 1B Study of the Safety and Pharmacokinetics of Ritonavir-Boosted Elvitegravir (GS-9137/r) Plus a Background Regimen (BR) in HIV-1 Infected, Antiretroviral Treatment-Experienced Adolescents
    Medical condition: Human Innunodeficiency Virus (HIV-1) Infections
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020192 HIV-1 LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-003616-20 Sponsor Protocol Number: MK1439A-030 Start Date*: 2015-12-29
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase IIa Multicenter, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A in Treatment-Naïve HIV-1 Infected Subjects with Selected Non-Nucleoside Reverse Transcriptase Inhi...
    Medical condition: Human Immunodeficiency Virus-1 infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10000807 Acute HIV infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed)
    Trial results: View results
    EudraCT Number: 2012-002663-10 Sponsor Protocol Number: SSAT049 Start Date*: 2012-11-12
    Sponsor Name:St Stephen's AIDS Trust
    Full Title: A phase IV, open-label single-arm study investigating the pharmacokinetics and pharmacodynamics of the antiretroviral combination of rilpivirine and ritonavir-boosted darunavir in therapy-naive HIV...
    Medical condition: HIV-1
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-006102-23 Sponsor Protocol Number: ImmuneRaRe_RF-2019-12369708 Start Date*: 2021-10-13
    Sponsor Name:OSPEDALE SAN RAFFAELE
    Full Title: Study of a novel combination of immunovirologic and genetic parameters in early-treated HIV-1 patients undergone to antiretroviral therapy interruption (ATI) aimed at defining an algorithm predicti...
    Medical condition: HIV-1 positive subjects treated with effective antiretroviral therapy during the acute phase of HIV-1 infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    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: View results
    EudraCT Number: 2008-000881-22 Sponsor Protocol Number: M10-336 Start Date*: 2008-07-17
    Sponsor Name:Abbott GmbH & Co. KG
    Full Title: A Randomized, Open-label, Study of Lopinavir/ritonavir 400/100 mg Tablet Twice-Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once-Daily Versus Lopinavir/ritonavir 400...
    Medical condition: Treatment-naïve, HIV-1 infected subjects
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020162 HIV infection CDC Group I LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    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: 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: 2007-004225-26 Sponsor Protocol Number: GS-US-183-0145 Start Date*: 2008-08-13
    Sponsor Name:Gilead Sciences Incorporated
    Full Title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Backgrou...
    Medical condition: Human Innunodeficiency Virus (HIV-1) Infections
    Disease: Version SOC Term Classification Code Term Level
    15.0 10021881 - Infections and infestations 10020192 HIV-1 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) NL (Completed) BE (Completed) ES (Completed) IT (Completed) PT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2007-003418-32 Sponsor Protocol Number: GS-US-104-0352 Start Date*: 2007-12-18
    Sponsor Name:Gilead Sciences Incorporated
    Full Title: A Phase III, Randomised, Open- Label Study Comparing the Safety and Efficacy of Switching Stavudine or Zidovudine to Tenofovir Disoproxil Fumarate versus Continuing Stavudine or Zidovudine in Virol...
    Medical condition: HIV-1 infected children (2 years to less than 12 years), who are virologically suppressed with HIV-1 RNA less than 400 copies/mL on their current antiretroviral regimen.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020192 HIV-1 LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004820-24 Sponsor Protocol Number: COST-EFFECT-CLINIC Start Date*: 2015-06-02
    Sponsor Name:Fundació Clínic per a la Recerca Biomèdica
    Full Title: Cost-effectiveness of different antiretroviral treatment in patients HIV naive. Randomized clinical, not masked, trial comparing DRVr3TC, ABC3TC (Kivexa) RPV, or EVG COBI FTC TDF (Stribild) for 48...
    Medical condition: in patients HIV naive. Randomized clinical, not masked, trial comparing DRVr3TC, ABC3TC (Kivexa) RPV, or EVG COBI FTC TDF (Stribild) for 48 weeks
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (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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