Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
28
Countries
1
Sites
1
HIV infection
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 31 Jul 2025 → ongoing
- Decision date (initial)
- 2025-07-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-521102-17-00
- WHO UTN
- U1111-1318-7985
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
HIV infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10020161 | HIV infection | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Russ Carstens
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Russ Carstens
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Romania | Ongoing, recruiting | 14 | 1 |
| Rest of world
Moldova, Republic of
|
— | 14 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Romania | 2025-07-31 | 2025-08-05 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-04 | Romania | No conclusion 2025-07-21
|
2025-07-25 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-02 | Romania | No conclusion 2025-07-21
|
2025-09-02 |