Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
6
Countries
1
Sites
1
Human Immunodeficiency Virus (HIV)
Key facts
- Sponsor
- International AIDS Vaccine Initiative Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 19 Mar 2024 → ongoing
- Decision date (initial)
- 2024-02-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-508157-15-01
- ClinicalTrials.gov
- NCT05983874
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Human Immunodeficiency Virus (HIV)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
International AIDS Vaccine Initiative Inc.
- Sponsor organisation
- International AIDS Vaccine Initiative Inc.
- Address
- 1600 East Gude Drive
- City
- Rockville
- Postcode
- 20850-1496
- Country
- United States
Scientific contact point
- Organisation
- International AIDS Vaccine Initiative Inc.
- Contact name
- Allison Kennedy
Public contact point
- Organisation
- International AIDS Vaccine Initiative Inc.
- Contact name
- Allison Kennedy
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 6 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Amsterdam UMC
Internal Medicine, De Boelelaan 1117, 1081 HV, Amsterdam
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 | 2024-03-19 | 2025-07-15 | 2024-03-20 | 2024-07-10 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-11 | Netherlands | Acceptable 2024-02-09
|
2024-02-09 |