EUCTR2015-000054-37-BEActive, not recruitingPhase 1
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 enrollmentStarted: June 15, 2015Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •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.
Investigators
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