Clinical trial • Phase III • Infectious Disease
fostemsavir for HIV infection | HIV-1 infection
Phase III trial of fostemsavir for HIV infection | HIV-1 infection.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- HIV infection | HIV-1 infection
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 30-05-2025
- First CTIS Authorization Date
- 22-09-2025
Trial design
Randomised, open-label, background integrase inhibitor-based antiretroviral therapy (background art) versus addition of vh3810109 with or without fostemsavir; doses and schedules not specified-controlled Phase III trial across 25 sites in Denmark, Spain, Belgium and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Background integrase inhibitor-based antiretroviral therapy (background ART) versus addition of VH3810109 with or without fostemsavir; doses and schedules not specified
- Target Sample Size
- 72
Recruitment
- Planned Sample Size
- 72
- Recruitment Window Months
- 31
Geography
- Total Number Of Sites
- 25
- Total Number Of Participants
- 72
Denmark
- Earliest CTIS Part Ii Submission Date
- 27-08-2025
- Latest Decision Or Authorization Date
- 22-09-2025
- Processing Time Days
- 26
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Region Midtjylland
- Department Name
- Department of Infectious Diseases
- Principal Investigator Name
- Ole Søgaard
- Principal Investigator Email
- clin@au.dk
- Contact Person Name
- Ole Søgaard
- Contact Person Email
- clin@au.dk
- Site Name
- Region Hovedstaden
- Department Name
- Department of Infectious Diseases
- Principal Investigator Name
- Thomas Benfield
- Principal Investigator Email
- firstname.middlename.lastname@regionh.dk
- Contact Person Name
- Thomas Benfield
- Contact Person Email
- firstname.middlename.lastname@regionh.dk
Spain
- Earliest CTIS Part Ii Submission Date
- 26-08-2025
- Latest Decision Or Authorization Date
- 26-09-2025
- Processing Time Days
- 31
- Number Of Sites
- 20
- Number Of Participants
- 57
Sites
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Infectious diseases service
- Principal Investigator Name
- Luis Fernando López Cortes
- Principal Investigator Email
- luisfernando@lopezcortes.net
- Contact Person Name
- Luis Fernando López Cortes
- Contact Person Email
- luisfernando@lopezcortes.net
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Internal Medicine Service
- Principal Investigator Name
- Miguel Górgolas Hernández-Mora
- Principal Investigator Email
- mgorgolas@fjd.es
- Contact Person Name
- Miguel Górgolas Hernández-Mora
- Contact Person Email
- mgorgolas@fjd.es
- Site Name
- University Hospital Son Espases
- Department Name
- Internal medicine service
- Principal Investigator Name
- Mercedes García Gassalla
- Principal Investigator Email
- mgarcia5@ssib.es
- Contact Person Name
- Mercedes García Gassalla
- Contact Person Email
- mgarcia5@ssib.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Infectious diseases service
- Principal Investigator Name
- Ana Moreno Zamora
- Principal Investigator Email
- einfecciosas.hrc@salud.madrid.org
- Contact Person Name
- Ana Moreno Zamora
- Contact Person Email
- einfecciosas.hrc@salud.madrid.org
- Site Name
- Hospital Universitario De Canarias
- Department Name
- Infectious diseases service
- Principal Investigator Name
- María Remedios Alemán Valls
- Principal Investigator Email
- remealeman@hotmail.com
- Contact Person Name
- María Remedios Alemán Valls
- Contact Person Email
- remealeman@hotmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Infectious diseases service
- Principal Investigator Name
- Marta Montero Alonso
- Principal Investigator Email
- montero_mar@gva.es
- Contact Person Name
- Marta Montero Alonso
- Contact Person Email
- montero_mar@gva.es
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Internal medicine service
- Principal Investigator Name
- Alberto Díaz de Santiago
- Principal Investigator Email
- ddsalbertorubio@hotmail.com
- Contact Person Name
- Alberto Díaz de Santiago
- Contact Person Email
- ddsalbertorubio@hotmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Internal Medicine Service
- Principal Investigator Name
- Juan González García
- Principal Investigator Email
- juangonzalezgar@gmail.com
- Contact Person Name
- Juan González García
- Contact Person Email
- juangonzalezgar@gmail.com
- Site Name
- Consorcio Hospital General Universitario De Valencia
- Department Name
- Infectious diseases service
- Principal Investigator Name
- Miguel García Deltoro
- Principal Investigator Email
- garcia_migdel@gva.es
- Contact Person Name
- Miguel García Deltoro
- Contact Person Email
- garcia_migdel@gva.es
- Site Name
- Bellvitge University Hospital
- Department Name
- Infectious diseases service
- Principal Investigator Name
- Juan Manuel Tiraboschi
- Principal Investigator Email
- jmtiraboschi@bellvitgehospital.cat
- Contact Person Name
- Juan Manuel Tiraboschi
- Contact Person Email
- jmtiraboschi@bellvitgehospital.cat
- Site Name
- Hospital Del Mar
- Department Name
- Infectious diseases service
- Principal Investigator Name
- Roberto Güerri - Fernández
- Principal Investigator Email
- rguerri@psmar.cat
- Contact Person Name
- Roberto Güerri - Fernández
- Contact Person Email
- rguerri@psmar.cat
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Infectious diseases service
- Principal Investigator Name
- Ignacio Pérez Valero
- Principal Investigator Email
- ignacio.perez.valero.sspa@juntadeandalucia.es
- Contact Person Name
- Ignacio Pérez Valero
- Contact Person Email
- ignacio.perez.valero.sspa@juntadeandalucia.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Infectious diseases service
- Principal Investigator Name
- Josep Mallolas Masferrer
- Principal Investigator Email
- mallolas@clinic.cat
- Contact Person Name
- Josep Mallolas Masferrer
- Contact Person Email
- mallolas@clinic.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Internal Medicine Service
- Principal Investigator Name
- David Rial Crestelo
- Principal Investigator Email
- davidrialcreste@gmail.com
- Contact Person Name
- David Rial Crestelo
- Contact Person Email
- davidrialcreste@gmail.com
- Site Name
- Hospital Son Llatzer
- Department Name
- Internal medicine service
- Principal Investigator Name
- Aroa Villoslada Gelabert
- Principal Investigator Email
- avilloslada@hsll.es
- Contact Person Name
- Aroa Villoslada Gelabert
- Contact Person Email
- avilloslada@hsll.es
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Internal Medicine Service
- Principal Investigator Name
- Pere Domingo Pedrol
- Principal Investigator Email
- PDomingo@santpau.cat
- Contact Person Name
- Pere Domingo Pedrol
- Contact Person Email
- PDomingo@santpau.cat
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Infectious diseases service
- Principal Investigator Name
- Vicente Estrada Pérez
- Principal Investigator Email
- vicente.estrada@salud.madrid.org
- Contact Person Name
- Vicente Estrada Pérez
- Contact Person Email
- vicente.estrada@salud.madrid.org
- Site Name
- Hospital Universitario Infanta Leonor
- Department Name
- Internal medicine service
- Principal Investigator Name
- Guillermo Cuevas Tascón
- Principal Investigator Email
- guillermocuevastascon@gmail.com
- Contact Person Name
- Guillermo Cuevas Tascón
- Contact Person Email
- guillermocuevastascon@gmail.com
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Infectious diseases service
- Principal Investigator Name
- Beatriz Mothe Pujadas
- Principal Investigator Email
- bmothe@lluita.org
- Contact Person Name
- Beatriz Mothe Pujadas
- Contact Person Email
- bmothe@lluita.org
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Infectious diseases service
- Principal Investigator Name
- Adrián Curran Fábregas
- Principal Investigator Email
- acurran@vhebron.net
- Contact Person Name
- Adrián Curran Fábregas
- Contact Person Email
- acurran@vhebron.net
Belgium
- Earliest CTIS Part Ii Submission Date
- 14-08-2025
- Latest Decision Or Authorization Date
- 23-09-2025
- Processing Time Days
- 40
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- CHU Saint Pierre
- Department Name
- Department of Internal Medicine
- Principal Investigator Name
- Nicolas Dauby
- Principal Investigator Email
- nicolas.dauby@stpierre-bru.be
- Contact Person Name
- Nicolas Dauby
- Contact Person Email
- nicolas.dauby@stpierre-bru.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Department of Internal Medicine
- Principal Investigator Name
- Linos Vandekerckhove
- Principal Investigator Email
- linos.vandekerckhove@uzgent.be
- Contact Person Name
- Linos Vandekerckhove
- Contact Person Email
- linos.vandekerckhove@uzgent.be
Netherlands
- Earliest CTIS Part Ii Submission Date
- 22-09-2025
- Latest Decision Or Authorization Date
- 23-09-2025
- Processing Time Days
- 1
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Department of Internal Medicine
- Principal Investigator Name
- Casper Rokx
- Principal Investigator Email
- c.rokx@erasmusmc.nl
- Contact Person Name
- Casper Rokx
- Contact Person Email
- c.rokx@erasmusmc.nl
Sponsor
Primary sponsor
- Full Name
- Viiv Healthcare UK Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Investigational products
- Investigational Product Name
- VH3810109
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Investigational Product Name
- fostemsavir
- Active Substance
- fostemsavir
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Combination Treatment
- Yes
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