HIV prevention study with HIV-medicine in gay man in Belgium at high risk for acquiring HIV.

Phase 1

• Conditions: HIV prevention; Therapeutic area: Health Care [N] - Environment and Public Health [N06]

• Registration Number: EUCTR2015-000054-37-BE
• Lead Sponsor: Institute of Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-15
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 200

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified