Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
100
Countries
4
Sites
25
HIV Infections
Key facts
- Sponsor
- Viiv Healthcare UK Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 1 Oct 2025 → ongoing
- Decision date (initial)
- 2025-09-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
HIV Infections
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | LLT | 10068341 | HIV-1 infection | 10021881 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Viiv Healthcare UK Limited
- Sponsor organisation
- Viiv Healthcare UK Limited
- Address
- 79 New Oxford Street
- City
- London
- Postcode
- WC1A 1DG
- Country
- United Kingdom
Scientific contact point
- Organisation
- Viiv Healthcare UK Limited
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Viiv Healthcare UK Limited
- Contact name
- EU GSK Clinical Trials Call Center
Locations
4 EU/EEA countries · 25 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 6 | 2 |
| Denmark | Ongoing, recruitment ended | 6 | 2 |
| Netherlands | Ongoing, recruitment ended | 3 | 1 |
| Spain | Ongoing, recruitment ended | 57 | 20 |
| Rest of world
United States, United Kingdom
|
— | 28 | — |
Investigational sites
Universitair Ziekenhuis Gent
Department of Internal Medicine, Corneel Heymanslaan 10, 9000, Gent
CHU Saint Pierre
Department of Internal Medicine, Hoogstraat 322, 1000, Brussels
Region Midtjylland
Department of Infectious Diseases, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Region Hovedstaden
Department of Infectious Diseases, Kettegaard Alle 30, 2650, Hvidovre
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department of Internal Medicine, Wytemaweg 80, 3015 CN, Rotterdam
Hospital Universitario Fundacion Jimenez Diaz
Internal Medicine Service, Avenida De Los Reyes Catolicos 2, 28040, Madrid
University Hospital Virgen Del Rocio S.L.
Infectious diseases service, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Y Politecnico La Fe
Infectious diseases service, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Puerta De Hierro De Majadahonda
Internal medicine service, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Universitario De Canarias
Infectious diseases service, Carretera Ofra S/N, 38320, San Cristobal De La Laguna
Hospital Del Mar
Infectious diseases service, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario 12 De Octubre
Internal Medicine Service, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitari Vall D Hebron
Infectious diseases service, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Reina Sofia
Infectious diseases service, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Ramon Y Cajal
Infectious diseases service, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Infanta Leonor
Internal medicine service, Avenida Gran Via Del Este 80, 28031, Madrid
Hospital Son Llatzer
Internal medicine service, Carretera De Manacor Km 4, 07198, Palma
Hospital Germans Trias I Pujol
Infectious diseases service, Carretera Canyet 1a Planta, 08916, Badalona
Bellvitge University Hospital
Infectious diseases service, Carrer De La Feixa Llarga S/N, 08907, L'Hospitalet De Llobregat
Hospital De La Santa Creu I Sant Pau
Internal Medicine Service, Carrer De San Quinti 89, 08041, Barcelona
University Hospital Son Espases
Internal medicine service, Carretera Valldemossa 79, 07120, Palma
Hospital Clinic De Barcelona
Infectious diseases service, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario La Paz
Internal Medicine Service, Paseo De La Castellana 261, 28046, Madrid
Consorcio Hospital General Universitario De Valencia
Infectious diseases service, Avenida Tres Cruces 2, 46014, Valencia
Hospital Clinico San Carlos
Infectious diseases service, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2025-11-13 | 2025-11-13 | 2026-01-19 | ||
| Denmark | 2025-10-24 | 2025-10-24 | 2026-01-26 | ||
| Netherlands | 2025-12-11 | 2025-12-11 | 2026-01-23 | ||
| Spain | 2025-10-01 | 2025-10-01 | 2026-01-26 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-30 | Denmark | Acceptable 2025-09-22
|
2025-09-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-25 | Acceptable | 2026-01-14 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-14 | 2026-01-14 | ||
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-29 | Denmark | 2026-01-29 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-03-19 | Denmark | 2026-03-19 |