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Clinical trials for Mother-to-child transmission

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   44346   clinical trials with a EudraCT protocol, of which   7374   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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    17 result(s) found for: Mother-to-child transmission. Displaying page 1 of 1.
    EudraCT Number: 2020-001587-29 Sponsor Protocol Number: 02/04/2020-001 Start Date*: 2020-04-08
    Sponsor Name:Barcelona Institute for Global Health (ISGlobal)
    Full Title: Hydroxychloroquine efficacy in preventing SARS-CoV-2 infection and CoVid-19 disease severity during pregnancy
    Medical condition: SARS-SoV-2 infection and CoVid-19 disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10051905 Coronavirus infection LLT
    Population Age: Adults Gender: Male
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-004571-12 Sponsor Protocol Number: ANRS160RalFE Start Date*: 2014-02-06
    Sponsor Name:Inserm-ANRS
    Full Title: Evaluation of the pharmacokinetic properties and the tolerance of raltegravir during the third trimester of pregnancy
    Medical condition: HIV and pregnancy
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004865 10073025 Prevention of mother to child transmission of HIV infection LLT
    Population Age: In utero, Preterm newborn infants, Newborns, Infants and toddlers, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    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: 2011-002268-26 Sponsor Protocol Number: CTN240 Start Date*: 2013-01-02
    Sponsor Name:University Health Network, Toronto General Hospital
    Full Title: Valacyclovir in Delaying Antiretroviral Treatment Entry (VALIDATE)
    Medical condition: Coinfection of Human Immunodeficiency Virus and Herpes Simplex Virus type 2
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (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: 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)
    EudraCT Number: 2009-017809-11 Sponsor Protocol Number: 112673 Start Date*: 2010-09-27
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase I/IIa randomized, observer-blind, placebo-controlled, multicenter study to evaluate the safety and immunogenicity of the GSK Biologicals’ herpes zoster vaccine, gE/AS01B in comparison to pl...
    Medical condition: Vaccination against herpes zoster (HZ) in adult HIV-infected subjects.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10019974 Herpes zoster PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-000437-32 Sponsor Protocol Number: MK-8591-011 Start Date*: 2017-12-18
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 2B, Randomized, Double-Blind, Active-Comparator-Controlled, Dose- Ranging Clinical Trial to Evaluate the Safety, Tolerability, Antiretroviral Activity, and Pharmacokinetics of MK-8591 Given...
    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: GB (GB - no longer in EU/EEA) FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-001358-84 Sponsor Protocol Number: 1708212 Start Date*: 2018-10-12
    Sponsor Name:CHU de Saint Etienne
    Full Title: Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 positive subjects commencing Antiretroviral Therapy
    Medical condition: HIV-positive subjects initiating antiretroviral therapy
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10020160 HIV disease LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-022413-26 Sponsor Protocol Number: IDEAL-Study Start Date*: 2011-07-29
    Sponsor Name:University Medical Center Hamburg-Eppendorf
    Full Title: Immediate versus deferred antiretroviral therapy in HIV-infected patients presenting with acute AIDS-defining events (IDEAL-Study)
    Medical condition: Patients in late stage of HIV-infection, treatment naive or without ART for the last 6 month with an acute AIDS-defining illness, namely PCP or TE.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10001509 AIDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002780-26 Sponsor Protocol Number: GS-US-292-0106 Start Date*: 2015-01-27
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in H...
    Medical condition: Human Immunodeficiency Virus (HIV-1) Infection
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-001680-44 Sponsor Protocol Number: P1111 Start Date*: 2014-01-24
    Sponsor Name:The National Institute of Allergy and Infectious Diseases (NIAID)
    Full Title: A Phase I/II, Open-Label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Rilpivirine in Antiretroviral Naive HIV-1 Infected Children, < 12 Years of Age
    Medical condition: HIV-1 Infection
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004862 10020192 HIV-1 LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    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: 2007-003133-16 Sponsor Protocol Number: P04875 Start Date*: 2008-02-15
    Sponsor Name:SCHERING-PLOUGH
    Full Title: Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects
    Medical condition: HIV INFECTION IN NAIVE PATIENTS
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020161 HIV infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) ES (Prematurely Ended) PT (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-021356-26 Sponsor Protocol Number: 111679 Start Date*: 2011-01-03
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase IIb, randomized, observer-blind, placebo controlled, multicenter primary/booster therapeutic vaccination study to determine efficacy and safety of F4co/ AS01B vaccine, administered intramus...
    Medical condition: ART-naïve HIV-infected adults (ART: anti-retroviral therapy)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10020161 HIV infection PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2008-001696-30 Sponsor Protocol Number: TMC278-TiDP38-C213 Start Date*: 2009-01-21
    Sponsor Name:Tibotec Pharmaceuticals Ltd.
    Full Title: Ensayo fase II, abierto, de un solo brazo de tratamiento para evaluar la farmacocinética, seguridad, tolerabilidad y actividad antiviral de TMC278 en pacientes adolescentes de entre 12 y 18 años de...
    Medical condition: HIV-1 Infection
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020161 HIV infection LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-012947-40 Sponsor Protocol Number: PENTA16 Start Date*: 2010-08-11
    Sponsor Name:PENTA Foundation [...]
    1. PENTA Foundation
    2. Medical Research Council
    Full Title: BREATHER (PENTA 16): Short-cycle therapy (SCT) (5 days on/ 2 days off) in young people with chronic HIV-infection
    Medical condition: HIV-1 Infection
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IE (Completed) GB (Completed) ES (Completed) DK (Completed) BE (Completed) DE (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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