Clinical trial • Phase I • Infectious Disease

Clinical trial in HIV-1 infection

Phase I trial for HIV-1 infection. open-label, none/not specified-controlled. 15 participants.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
HIV-1 infection
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
30-09-2024
First CTIS Authorization Date
16-10-2024

Trial design

open-label, none/not specified-controlled Phase I trial across 1 site in Belgium.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
15

Eligibility

Recruits 15 isVulnerablePopulationSelected: false.

Vulnerable Population
isVulnerablePopulationSelected: false

Recruitment

Planned Sample Size
15
Recruitment Window Months
47

Geography

Total Number Of Sites
1
Total Number Of Participants
15

Belgium

Earliest CTIS Part Ii Submission Date
10-10-2024
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
494
Number Of Sites
1
Number Of Participants
15

Sites

Site Name
CHU Saint-Pierre
Department Name
Maladies infectieuses
Principal Investigator Name
Stéphane DE WIT
Principal Investigator Email
stephane.dewit@stpierre-bru.be
Contact Person Name
Stéphane DE WIT
Contact Person Email
stephane.dewit@stpierre-bru.be
Number Of Participants
15

Sponsor

Primary sponsor

Full Name
ANRS Maladies Infectieuses Emergentes
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
France

Investigational products

Combination Treatment
Yes

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