Be-PrEP-ared: HIV prevention with Pre-exposure prophylaxis –a demonstration project in high risk men having sex with men in Belgium - Be-PrEP-ared

Institute of Tropical Medicine0 sites200 target enrollmentJune 15, 2015

Overview

No summary available.

Registry

who.int

Start Date

June 15, 2015

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

Institute of Tropical Medicine

•1\) Able and willing to provide written informed consent
•2\) Born to male sex and age of 18 years or more (including transgender females)
•3\) Had sex with a man in the last 12 months
•4\) HIV negative (confirmed at enrollment)
•5\) At least one criterion for High Risk”:
•\- Reported unprotected (\= condomless) anal intercourse (UAI) in the last six months with a casual partner (with unknown HIV status or HIV positive status))
•\- Reported STI episode in the last six months
•\- Taken PEP in the last six months
•6\) Able and willing to participate in the study as required by the protocol for 18 months
•7\) Motivation to strengthen their own prevention efforts, including interest in starting/consider to use PrEP

•1\) Having symptoms/clinical signs consistent with acute HIV infection1 (AHI)
•2\) Being allergic to the active substances or any of the excipients.
•3\) Having an estimated creatinine clearance of \< 60 mL/minute according to the Modification of Diet in Renal Disease (MDRD) formula
•4\) Having an active Hepatitis B infection (see table 1 for different scenario’s)
•5\) Taking HIV PEP, medicinal products containing emtricitabine, tenofovir disoproxil or other cytidine analogues (such as lamivudine), adefovir dipivoxil.
•6\) Participating in other clinical studies (phase I\-III) or another research study related to HIV/ARV.