Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Authorised, recruitment pending
Participants planned
55
Countries
1
Sites
2
HIV
Key facts
- Sponsor
- Hvidovre Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Decision date (initial)
- 2024-10-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516961-35-01
- EudraCT number
- 2020-000863-22
- ClinicalTrials.gov
- NCT04875819
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
HIV
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hvidovre Hospital
- Sponsor organisation
- Hvidovre Hospital
- Address
- Kettegaard Alle 30
- City
- Hvidovre
- Postcode
- 2650
- Country
- Denmark
Scientific contact point
- Organisation
- Hvidovre Hospital
- Contact name
- Michaela Tinggaard
Public contact point
- Organisation
- Hvidovre Hospital
- Contact name
- Michaela Tinggaard
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 55 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Hvidovre Hospital
Infectious Diseases, 144, Kettegaard Alle 30, 2650, Hvidovre
GCP-enheden ved Københavns Universitetshospital
GCP unit, Frederiksberg Hospital, Nordre Fasanvej 57,, Frederiksberg
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-23 | Denmark | Acceptable 2024-10-11
|
2024-10-11 |