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Clinical Trials/EUCTR2014-002569-32-NL
EUCTR2014-002569-32-NL
Active, not recruiting
Not Applicable

Biomedical interventions for HIV prevention in MSM in Amsterdam: a demonstration project

Academic Medical Center0 sitesApril 29, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
prevention of HIV infection
Sponsor
Academic Medical Center
Status
Active, not recruiting
Last Updated
10 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 29, 2015
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
Academic Medical Center

Eligibility Criteria

Inclusion Criteria

  • 1\.Male or transgender, age 18 years or more
  • 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

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

Outcomes

Primary Outcomes

Not specified

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