Clinical trial • Phase III • Infectious Disease

MK-4646 for HIV infection

Phase III trial of MK-4646 for HIV infection. 14 participants.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
HIV infection
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
04-04-2025
First CTIS Authorization Date
25-07-2025

Trial design

Phase III trial across 1 site in Romania.

Target Sample Size
14

Eligibility

Recruits 14 Vulnerable population selected; no further details on consent or assent handling provided in source..

Vulnerable Population
Vulnerable population selected; no further details on consent or assent handling provided in source.

Recruitment

Planned Sample Size
14
Recruitment Window Months
6

Geography

Total Number Of Sites
1
Total Number Of Participants
14

Romania

Earliest CTIS Part Ii Submission Date
14-04-2025
Latest Decision Or Authorization Date
25-07-2025
Processing Time Days
102
Number Of Sites
1
Number Of Participants
14

Sites

Site Name
Institutul National De Boli Infectioase Prof.Dr.Matei Bals
Department Name
Institutul National De Boli Infectioase Prof.Dr.Matei Bals ‘Phase I Unit: Pavilion 1, Wards 2,3,4'
Contact Person Name
Anca Streinu-Cercel
Contact Person Email
anca.streinucercel@gmail.com
Number Of Participants
14

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
MK-4646

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