Clinical trial • Infectious Disease

Clinical trial in HIV infection

Clinical trial for HIV infection. Randomised, open-label. 55 participants.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
HIV infection

Key dates

Initial CTIS Submission Date
23-09-2024
First CTIS Authorization Date
11-10-2024

Trial design

Randomised, open-label trial across 2 sites in Denmark.

Randomised
Yes
Open Label
Yes
Target Sample Size
55

Eligibility

Recruits 55 No vulnerable population selected.

Vulnerable Population
No vulnerable population selected

Recruitment

Planned Sample Size
55
Recruitment Window Months
80

Geography

Total Number Of Sites
2
Total Number Of Participants
55

Denmark

Earliest CTIS Part Ii Submission Date
04-10-2024
Latest Decision Or Authorization Date
11-10-2024
Processing Time Days
7
Number Of Sites
2
Number Of Participants
55

Sites

Site Name
Hvidovre Hospital
Department Name
Infectious Diseases, 144
Principal Investigator Name
Michaela Tinggaard
Principal Investigator Email
michaela.tinggaard@regionh.dk
Contact Person Name
Michaela Tinggaard
Contact Person Email
michaela.tinggaard@regionh.dk
Site Name
GCP-enheden ved Københavns Universitetshospital
Department Name
GCP unit
Contact Person Name
GCP Unit

Sponsor

Primary sponsor

Full Name
Hvidovre Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

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