Clinical trial • Phase III • Infectious Disease
Lamivudine; Dolutegravir sodium for HIV-1 infection
Phase III trial of Lamivudine; Dolutegravir sodium for HIV-1 infection.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- HIV-1 infection
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 14-09-2023
- First CTIS Authorization Date
- 22-01-2024
Trial design
Randomised, open-label, dtg/3tc fdc (dovato 50 mg/300 mg film-coated tablets) once daily versus bic/ftc/taf fdc (biktarvy 50 mg/200 mg/25 mg film-coated tablets) once daily-controlled Phase III trial across 46 sites in Spain, Greece, Ireland and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- DTG/3TC FDC (Dovato 50 mg/300 mg film-coated tablets) once daily versus BIC/FTC/TAF FDC (Biktarvy 50 mg/200 mg/25 mg film-coated tablets) once daily
- Target Sample Size
- 130
- Trial Duration For Participant
- 672
Eligibility
Recruits 130 Vulnerable population selected. Consent: 'Participant (or participant’s Legally Acceptable Representative) is capable of giving written informed consent.' No paediatric/assent procedures specified; participants must be ≥18 years..
- Pregnancy Exclusion
- Pregnant or breastfeeding women or those planning to become pregnant or breastfeed during the study.
- Vulnerable Population
- Vulnerable population selected. Consent: 'Participant (or participant’s Legally Acceptable Representative) is capable of giving written informed consent.' No paediatric/assent procedures specified; participants must be ≥18 years.
Inclusion criteria
- {"criterion_text":"- Age ≥18 years (or older, if required by local regulations) at the time of obtaining informed consent.\n- Male or female. Female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at Screening and a negative urine hCG test at Enrolment) and not lactating.\n- Antiretroviral-naïve (no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) PWH.\n- Participant (or participant’s Legally Acceptable Representative) is capable of giving written informed consent.\n- Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category."}
Exclusion criteria
- {"criterion_text":"- 1.\tPregnant or breastfeeding women or those planning to become pregnant or breastfeed during the study.\n- 2.\tActive CDC Stage 3 disease is excluded, except for cutaneous Kaposi's sarcoma not needing systemic therapy, and CD4 cell counts below 200 cells/mm3.\n- 3.\tPrevious or current allergy or intolerance to the study treatment, its components, drugs of their class, or other allergies that contraindicate participation.\n- 4.\tOngoing or clinically relevant pancreatitis.\n- 5.\tOngoing malignancy, except for specific cases agreed upon by the Investigator and Medical Monitor.\n- 6.\tSevere hepatic impairment (Class C) as per Child-Pugh classification.\n- 7.\tUnstable liver disease or known biliary abnormalities (excluding Gilbert's syndrome, asymptomatic gallstones or stable chronic liver disease).\n- 8.\tHistory of liver cirrhosis with or without hepatitis viral co-infection.\n- 9.\tAlanine aminotransferase (ALT) levels ≥5 times the upper limit of normal (ULN) or ALT ≥3xULN with bilirubin ≥1.5xULN (with >35% direct bilirubin).\n- 10.\tSignificant suicidality risk, based on investigator judgment or history of suicidal behavior or ideation.\n- 11. \tSigns and symptoms suggestive of active SARS-CoV-2 infection within 14 days before enrolment.\n- 12. \tEvidence of hepatitis B virus (HBV) infection based on the results of testing at Screening, unless immune.\n- 13. \tParticipants with HCV co-infection are eligible if: liver enzymes meet entry criteria; there is no anticipated requirement for concomitant HCV treatment with potential adverse drug interactions, and HCV disease has undergone appropriate work-up and is not advanced or associated with cirrhosis.\n- 14. \tUntreated syphilis infection (positive RPR at Screening). Participants ≥7 days post completed treatment are eligible.\n- 15. \tMajor resistance-associated mutations to specified drugs based on resistance guidelines.\n- 16. \tRecent exposure to experimental drugs or vaccines, meeting protocol-defined conditions, before first dose of study drug.\n- 17. \tTreatment with radiation therapy, cytotoxic chemotherapeutic agents, or systemic immune suppressants within 28 days of screening.\n- 18. \tTreatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening.\n- 19. \tTreatment with agents active against HIV-1, except recognized antiretroviral therapy (ART), within 28days of first study dose.\n- 20. \tParticipants receiving protocol-defined prohibited medications who are unwilling or unable to switch to alternate medication.\n- 21. \tGrade 4 laboratory abnormalities, excluding lipid abnormalities.\n- 22. \tAcute laboratory abnormalities at Screening that, per investigator judgement, preclude participation in a clinical trial.\n- 23. \tEstimated creatine clearance below 30 mL/min per 1.73 m2 using the refitted, race-neutral CKD-EPIcr_R method.\n- 24. \tKnown or suspected acquisition of HIV-1 during either pre-exposure prophylaxis or post-exposure prophylaxis use, requiring consultation with Medical Monitor before enrolment.\n- 25. \tConditions affecting drug absorption, distribution, metabolism, or excretion.\n- 26. \tPre-existing conditions that may interfere with dosing, protocol compliance, or participant safety.\n- 27. \tCurrent or expected participation in another interventional study after randomization, unless pre- approved by the medical monitor."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Participant with plasma HIV-RNA <50 copies/mL as per Snapshot algorithm at Week 48","definition_or_measurement_approach":"Plasma HIV-RNA <50 copies/mL measured using the Snapshot algorithm at Week 48"}
Secondary endpoints
- {"endpoint_text":"- Participant with plasma HIV-1 RNA <50 c/mL (c/mL) at Weeks 96 as per the Snapshot algorithm","definition_or_measurement_approach":"Plasma HIV-1 RNA <50 copies/mL measured using the Snapshot algorithm at Week 96"}
- {"endpoint_text":"- Participant with HIV-RNA >/= 50 c/mL as per Snapshot algorithm at Week 48, and Week 96","definition_or_measurement_approach":"Plasma HIV-RNA ≥50 copies/mL as defined by the Snapshot algorithm at Weeks 48 and 96"}
- {"endpoint_text":"- Change from Baseline in HIV-1 RNA (log10 c/mL) and CD4+ cell count and CD4/CD8 ratio over time through Week 48 and Week 96.","definition_or_measurement_approach":"Change from baseline in HIV-1 RNA (log10 copies/mL), CD4+ cell count and CD4/CD8 ratio assessed over time through Weeks 48 and 96"}
- {"endpoint_text":"- Occurrence of disease progression (HIVassociated conditionsAIDS and death) through Week 48 and Week 96.","definition_or_measurement_approach":"Incidence of disease progression (HIV-associated conditions, AIDS, and death) assessed through Weeks 48 and 96"}
Recruitment
- Digital Remote Recruitment
- True — eConsent participant screens and electronic consent documents are included (L2 eConsent documents present for multiple countries). Medidata (third party) duties list EDC, digital eCOAs, eConsent indicating use of digital/remote consent and electronic data capture.
- Planned Sample Size
- 130
- Recruitment Window Months
- 40
- Consent Approach
- Written informed consent must be provided by the participant or the participant’s Legally Acceptable Representative ('Participant (or participant’s Legally Acceptable Representative) is capable of giving written informed consent.'). Subject information and ICF documents (main ICF, pregnancy ICF, treatment-restart ICF, provider ICF) are provided country- and language-specific (documents available in English, French, Spanish, Italian, German, Portuguese, Polish, Swedish, Greek, Dutch and others). eConsent participant screens (L2) are provided for some countries.
Methods
- GP letter (document titles present: e.g. K2_219816_GP-Letter_IE_English_Public) — country-specific GP letter documents present (Ireland, Italy, Portugal, etc.).
- Recruitment arrangements documents (titles K1_219816_Recruitment-Arrangements_...) available for multiple countries (DE, IE, IT, PL, SE, FR, GR, PT, BE, ES, DK) — country-specific recruitment arrangement files are listed in the public documents.
Geography
- Total Number Of Sites
- 46
- Total Number Of Participants
- 378
Spain
- Earliest CTIS Part Ii Submission Date
- 02-10-2023
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 952
- Number Of Sites
- 11
- Number Of Participants
- 149
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio de Medicina Interna
- Principal Investigator Name
- Maria De Lagarde Sebastian
- Principal Investigator Email
- estudioshiv12@gmail.com
- Contact Person Name
- Maria De Lagarde Sebastian
- Contact Person Email
- estudioshiv12@gmail.com
- Site Name
- Hospital General Universitario De Elche
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Mar Masiá Canuto
- Principal Investigator Email
- marmasiac@gmail.com
- Contact Person Name
- Mar Masiá Canuto
- Contact Person Email
- marmasiac@gmail.com
- Site Name
- University Hospital Of Canary Islands
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Maria-Remedios Aleman-Valls
- Principal Investigator Email
- remealeman@hotmail.com
- Contact Person Name
- Maria-Remedios Aleman-Valls
- Contact Person Email
- remealeman@hotmail.com
- Site Name
- Hospital Costa Del Sol
- Department Name
- Servicio de Medicina Interna
- Principal Investigator Name
- Julian Olalla Sierra
- Principal Investigator Email
- Julio.olalla@gmail.com
- Contact Person Name
- Julian Olalla Sierra
- Contact Person Email
- Julio.olalla@gmail.com
- Site Name
- Hospital Son Llatzer
- Department Name
- Servicio de Medicina Interna
- Principal Investigator Name
- Patricia Sorni Moreno
- Principal Investigator Email
- patricia.sorni@hsll.es
- Contact Person Name
- Patricia Sorni Moreno
- Contact Person Email
- patricia.sorni@hsll.es
- Site Name
- Hospital General Universitario De Valencia
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Miguel Garcia Deltoro
- Principal Investigator Email
- gdeltoromiguel@gmail.com
- Contact Person Name
- Miguel Garcia Deltoro
- Contact Person Email
- gdeltoromiguel@gmail.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Miguel Górgolas Hernandez
- Principal Investigator Email
- mgorgolas@fjd.es
- Contact Person Name
- Miguel Górgolas Hernandez
- Contact Person Email
- mgorgolas@fjd.es
- Site Name
- Hospital Universitario La Paz
- Department Name
- Servicio de Medicina Interna
- Principal Investigator Name
- Juan Julian Gonzalez Garcia
- Principal Investigator Email
- juangonzalezgar@gmail.com
- Contact Person Name
- Juan Julian Gonzalez Garcia
- Contact Person Email
- juangonzalezgar@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Joseph Mallolas Masferrer
- Principal Investigator Email
- mallolas@clinic.cat
- Contact Person Name
- Joseph Mallolas Masferrer
- Contact Person Email
- mallolas@clinic.cat
- Site Name
- University Hospital Son Espases
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Melchor Riera Jaume
- Principal Investigator Email
- melchor.riera@ssib.es
- Contact Person Name
- Melchor Riera Jaume
- Contact Person Email
- melchor.riera@ssib.es
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Servicio de Enfermedades Infecciosas
- Principal Investigator Name
- Lucia Bailon Alvarez
- Principal Investigator Email
- luciabailonalvarez@gmail.com
- Contact Person Name
- Lucia Bailon Alvarez
- Contact Person Email
- luciabailonalvarez@gmail.com
Greece
- Earliest CTIS Part Ii Submission Date
- 02-10-2023
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 910
- Number Of Sites
- 3
- Number Of Participants
- 25
Sites
- Site Name
- University General Hospital Of Thessaloniki Ahepa
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Symeon Metallidis
- Principal Investigator Email
- metallidissimeon@yahoo.gr
- Contact Person Name
- Symeon Metallidis
- Contact Person Email
- metallidissimeon@yahoo.gr
- Site Name
- General Hospital Of Athens Korgialenio Benakio H.R.C.
- Department Name
- Infectious Diseases Unit
- Principal Investigator Name
- Maria Chini
- Principal Investigator Email
- mariachini@gmail.com
- Contact Person Name
- Maria Chini
- Contact Person Email
- mariachini@gmail.com
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- 1st Department of Internal Medicine
- Principal Investigator Name
- Mina Psichogiou
- Principal Investigator Email
- mpsichog@med.uoa.gr
- Contact Person Name
- Mina Psichogiou
- Contact Person Email
- mpsichog@med.uoa.gr
Ireland
- Earliest CTIS Part Ii Submission Date
- 30-11-2023
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 848
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Beaumont Hospital
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Samuel McConkey
- Principal Investigator Email
- smcconkey@rcsi.ie
- Contact Person Name
- Samuel McConkey
- Contact Person Email
- smcconkey@rcsi.ie
- Site Name
- Mater Misericordiae University Hospital
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Aoife Grace Cotter
- Principal Investigator Email
- aoife.cotter@ucd.ie
- Contact Person Name
- Aoife Grace Cotter
- Contact Person Email
- aoife.cotter@ucd.ie
Portugal
- Earliest CTIS Part Ii Submission Date
- 20-11-2023
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 861
- Number Of Sites
- 2
- Number Of Participants
- 23
Sites
- Site Name
- Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.)
- Department Name
- Infectiology
- Principal Investigator Name
- Jorge Velez
- Principal Investigator Email
- jorge.velez.11346@chbv.min-saude.pt
- Contact Person Name
- Jorge Velez
- Contact Person Email
- jorge.velez.11346@chbv.min-saude.pt
- Site Name
- Centro Hospitalar Universitario Do Porto E.P.E.
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Josefina Mendez
- Principal Investigator Email
- josefinamendezvazquez@gmail.com
- Contact Person Name
- Josefina Mendez
- Contact Person Email
- josefinamendezvazquez@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 06-12-2023
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 847
- Number Of Sites
- 5
- Number Of Participants
- 31
Sites
- Site Name
- Azienda Ospedaliera Papa Giovanni XXIII
- Department Name
- Infectious Disease Unit – SC Malattie Infettive
- Principal Investigator Name
- Diego Ripamonti
- Principal Investigator Email
- dripamonti@asst-pg23.it
- Contact Person Name
- Diego Ripamonti
- Contact Person Email
- dripamonti@asst-pg23.it
- Site Name
- University Hospital Consorziale Policlinico
- Department Name
- UOC Malattie Infettive
- Principal Investigator Name
- Annalisa Saracino
- Principal Investigator Email
- annalisa.saracino@uniba.it
- Contact Person Name
- Annalisa Saracino
- Contact Person Email
- annalisa.saracino@uniba.it
- Site Name
- Azienda Ospedale-Universita Padova
- Department Name
- UOC Malattie Infettive e Tropicali
- Principal Investigator Name
- Anna Maria Cattelan
- Principal Investigator Email
- annamaria.cattelan@aopd.veneto.it
- Contact Person Name
- Anna Maria Cattelan
- Contact Person Email
- annamaria.cattelan@aopd.veneto.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- SC Malattie Infettive I
- Principal Investigator Name
- Roberto Gulminetti
- Principal Investigator Email
- r.gulminetti@smatteo.pv.it
- Contact Person Name
- Roberto Gulminetti
- Contact Person Email
- r.gulminetti@smatteo.pv.it
- Site Name
- Azienda Ospedaliero Universitaria Di Sassari
- Department Name
- SC Malattie Infettive e Tropicali
- Principal Investigator Name
- Giordano Madeddu
- Principal Investigator Email
- giordano@uniss.it
- Contact Person Name
- Giordano Madeddu
- Contact Person Email
- giordano@uniss.it
Poland
- Earliest CTIS Part Ii Submission Date
- 08-12-2023
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 844
- Number Of Sites
- 3
- Number Of Participants
- 36
Sites
- Site Name
- Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
- Department Name
- Oddział Kliniczny Chorób Zakaźnych i Hepatologii
- Principal Investigator Name
- Elżbieta Jabłonowska
- Principal Investigator Email
- elzbieta.jablonowska@umed.lodz.pl
- Contact Person Name
- Elżbieta Jabłonowska
- Contact Person Email
- elzbieta.jablonowska@umed.lodz.pl
- Site Name
- Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza w Bydgoszczy
- Department Name
- Oddział Internistyczno-Zakaźny i Niedoborów Odpornościowych
- Principal Investigator Name
- Anita Olczak
- Principal Investigator Email
- anita_olczak@interia.pl
- Contact Person Name
- Anita Olczak
- Contact Person Email
- anita_olczak@interia.pl
- Site Name
- Wroclawskie Centrum Zdrowia Samodzielny Publiczny Zaklad Opieki Zdrowotnej
- Department Name
- Ośrodek Profilaktyczno-leczniczy Chorób Zakaźnych i Terapii Uzależnień SPZOZ
- Principal Investigator Name
- Bartosz Szetela
- Principal Investigator Email
- bartoszetela@gmail.com
- Contact Person Name
- Bartosz Szetela
- Contact Person Email
- bartoszetela@gmail.com
Sweden
- Earliest CTIS Part Ii Submission Date
- 11-12-2023
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 837
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Infektionskliniken
- Principal Investigator Name
- Piotr Nowak
- Principal Investigator Email
- Piotr.nowak@regionstockholm.se
- Contact Person Name
- Piotr Nowak
- Contact Person Email
- Piotr.nowak@regionstockholm.se
France
- Earliest CTIS Part Ii Submission Date
- 08-12-2023
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 845
- Number Of Sites
- 10
- Number Of Participants
- 50
Sites
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Service Médecine interne et Maladies Infectieuses
- Principal Investigator Name
- Fabrice Bonnet
- Principal Investigator Email
- fabrice.bonnet@chu-bordeaux.fr
- Contact Person Name
- Fabrice Bonnet
- Contact Person Email
- fabrice.bonnet@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Charles Cazanave
- Principal Investigator Email
- charles.cazanave@chu-bordeaux.fr
- Contact Person Name
- Charles Cazanave
- Contact Person Email
- charles.cazanave@chu-bordeaux.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Matthieu Godinot
- Principal Investigator Email
- matthieu.godinot@chu-lyon.fr
- Contact Person Name
- Matthieu Godinot
- Contact Person Email
- matthieu.godinot@chu-lyon.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Karine Lacombe
- Principal Investigator Email
- karine.lacombe2@aphp.fr
- Contact Person Name
- Karine Lacombe
- Contact Person Email
- karine.lacombe2@aphp.fr
- Site Name
- CHRU Montpellier
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Alain Makinson
- Principal Investigator Email
- a-makinson@chu-montpellier.fr
- Contact Person Name
- Alain Makinson
- Contact Person Email
- a-makinson@chu-montpellier.fr
- Site Name
- Hopital Tenon
- Department Name
- Unité Maladies Infectieuses
- Principal Investigator Name
- Gilles Pailoux
- Principal Investigator Email
- gilles.pialoux@aphp.fr
- Contact Person Name
- Gilles Pailoux
- Contact Person Email
- gilles.pialoux@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Valérie Pourcher-Martinez
- Principal Investigator Email
- valerie.martinez@aphp.fr
- Contact Person Name
- Valérie Pourcher-Martinez
- Contact Person Email
- valerie.martinez@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Paul Loubet
- Principal Investigator Email
- paul.loubet@chu-nimes.fr
- Contact Person Name
- Paul Loubet
- Contact Person Email
- paul.loubet@chu-nimes.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Eric Cua
- Principal Investigator Email
- cua.e@chu-nice.f
- Contact Person Name
- Eric Cua
- Contact Person Email
- cua.e@chu-nice.f
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service des Maladies Infectieuses et Tropicales
- Principal Investigator Name
- Jade Ghosn
- Principal Investigator Email
- jade.ghosn@aphp.fr
- Contact Person Name
- Jade Ghosn
- Contact Person Email
- jade.ghosn@aphp.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 04-12-2023
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 848
- Number Of Sites
- 5
- Number Of Participants
- 19
Sites
- Site Name
- Praxis am Ebertplatz
- Principal Investigator Name
- Christoph Wyen
- Principal Investigator Email
- wyen@praxis-ebertplatz.de
- Contact Person Name
- Christoph Wyen
- Contact Person Email
- wyen@praxis-ebertplatz.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Medizinische Klinik und Poliklinik IV
- Principal Investigator Name
- Johannes Bogner
- Principal Investigator Email
- johannes.bogner@med.uni-muenchen.de
- Contact Person Name
- Johannes Bogner
- Contact Person Email
- johannes.bogner@med.uni-muenchen.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Medizinische Klinik 2, Schwerpunkt Infektiologie
- Principal Investigator Name
- Christoph Stephan
- Principal Investigator Email
- christoph.stephan@kgu.de
- Contact Person Name
- Christoph Stephan
- Contact Person Email
- christoph.stephan@kgu.de
- Site Name
- Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
- Principal Investigator Name
- Keikawus Arastéh
- Principal Investigator Email
- keikawus.arasteh@epimed.org
- Contact Person Name
- Keikawus Arastéh
- Contact Person Email
- keikawus.arasteh@epimed.org
- Site Name
- ICH Study Center GmbH & Co. KG
- Principal Investigator Name
- Christian Hoffmann
- Principal Investigator Email
- hoffmann@ich-hamburg.de
- Contact Person Name
- Christian Hoffmann
- Contact Person Email
- hoffmann@ich-hamburg.de
Denmark
- Earliest CTIS Part Ii Submission Date
- 20-12-2023
- Latest Decision Or Authorization Date
- 29-03-2026
- Processing Time Days
- 830
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Hvidovre Hospital
- Department Name
- Department of Infectious Diseases
- Principal Investigator Name
- Thomas Benfield
- Principal Investigator Email
- thomas.lars.benfield@regionh.dk
- Contact Person Name
- Thomas Benfield
- Contact Person Email
- thomas.lars.benfield@regionh.dk
Belgium
- Earliest CTIS Part Ii Submission Date
- 11-12-2023
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 842
- Number Of Sites
- 3
- Number Of Participants
- 40
Sites
- Site Name
- CHU Saint Pierre
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Charlotte Martin
- Principal Investigator Email
- charlotte_martin@stpierre-bru.be
- Contact Person Name
- Charlotte Martin
- Contact Person Email
- charlotte_martin@stpierre-bru.be
- Site Name
- Institute Of Tropical Medicine
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Maartje Van Frankenhuijsen
- Principal Investigator Email
- mvanfrankenhuijsen@itg.be
- Contact Person Name
- Maartje Van Frankenhuijsen
- Contact Person Email
- mvanfrankenhuijsen@itg.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- General Internal Diseases Clinic
- Principal Investigator Name
- Linos Vandekerckhove
- Principal Investigator Email
- linos.vandekerckhove@ugent.be
- Contact Person Name
- Linos Vandekerckhove
- Contact Person Email
- linos.vandekerckhove@ugent.be
Sponsor
Primary sponsor
- Full Name
- Viiv Healthcare UK Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Site portal
- Name
- PPD Global Central Labs
- Responsibilities
- Central Laboratory
- Name
- PPD Global Ltd.
- Responsibilities
- Local clinical trial-related duties in Greece (monitoring, Regulatory) and other CRO responsibilities
- Name
- PPD
- Responsibilities
- Safety submissions for EC/sites, IP destruction, monitoring and assorted trial operational duties
- Name
- Bioclinica Inc.
- Responsibilities
- Imaging/DEXA: Medical Imaging Core Laboratory services
- Name
- Monogram Biosciences Inc.
- Responsibilities
- HIV-1 resistance testing on blood samples for research purposes; sample storage for research
- Name
- Medidata Solutions Inc.
- Responsibilities
- EDC, digital eCOAs, eConsent
Third parties
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Site portal","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Central Laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Actigraph LLC","duties_or_roles":"Activity monitor 24 hours a day to measure patient activity and sleep (wearables)","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Cerba","duties_or_roles":"Resistance testing (genotypic and phenotypic)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging/DEXA: Medical Imaging Core Laboratory services","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Medicys Limited","duties_or_roles":"Build a website for sites to schedule interviews. Facilitate interviews with patients and providers in the EU. Transcribe all interviews from native language into English. Report adverse events raised during the interviews to sites.","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Monogram Biosciences Inc.","duties_or_roles":"HIV-1 resistance testing on blood samples for research purposes. Storage samples may be used for further research. No participant-level results reported to EU investigators or used for clinical management.","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"eCSSRS, ABPM 24H BP","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"EDC, digital eCOAs, eConsent","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"Local Clinical trial- related duties in Greece (monitoring, Regulatory)","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"PPD","duties_or_roles":"Multiple CRO roles including safety submissions for EC/sites, IP destruction, monitoring and other local duties","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Dovato 50 mg/300 mg film-coated tablets
- Active Substance
- Lamivudine; Dolutegravir sodium
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Marketing authorisation EU/1/19/1370/001 (authorised)
- Starting Dose
- Lamivudine 50 mg / Dolutegravir 300 mg once daily (fixed-dose combination)
- Frequency
- Once daily
- Investigational Product Name
- Biktarvy 50 mg/200 mg/25 mg film-coated tablets
- Active Substance
- Bictegravir; Emtricitabine; Tenofovir alafenamide
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Marketing authorisation EU/1/18/1289/001 (authorised)
- Starting Dose
- Bictegravir 50 mg / Emtricitabine 200 mg / Tenofovir alafenamide 25 mg once daily (fixed-dose combination)
- Frequency
- Once daily
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.