Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
9
Countries
1
Sites
1
human immunodeficiency virus (HIV)
Key facts
- Sponsor
- Viiv Healthcare UK Limited
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 3 Jun 2026 → ongoing
- Decision date (initial)
- 2026-05-18
- 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
human immunodeficiency virus (HIV)
| 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
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 9 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2026-06-03 | 2026-06-05 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-04-06 | Netherlands | Acceptable 2026-05-18
|
2026-05-18 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-06-15 | Netherlands | Acceptable 2026-05-18
|
2026-06-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-06-26 | Netherlands | Acceptable | 2026-07-06 |