HIV prevention for men who have sex with men using medicatio

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

• Registration Number: EUCTR2014-002569-32-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-29
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1.Male or transgender, age 18 years or more
2.MSM
3.Completed HIV and STI screening
4.HIV negative by 4th generation Elisa antigen/antibody test.
5.Willing and able to comply to project visit schedule and procedures
6.Willing and able to give written informed consent
7.Sufficient understanding of Dutch or English

AND at least one of the following:

1.One or more documented STI (urethral or anal chlamydia or gonorrhoea, primary or secondary syphilis) in the last 6 months (either at STI clinic or a documented infection diagnosed elsewhere)
2.UAI with casual partners in the last 6 months
3.Received PEP after sexual risk incident in the last 6 months
4.HIV positive partner with unknown or detectable viral load

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 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1.Signs or symptoms of acute HIV infection1
2.Hepatitis B infection (i.e. HbsAg positive)
3.Creatinine clearing (using cockroft gault formula) < 60 ml/min
4.Hypersensitivity for one of the components of fixed combination tablet containing tenofovir and emtricitabine
5.Unlikely, in the opinion of the clinician, to comply with trial schedule

Study & Design

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