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临床试验/EUCTR2014-002569-32-NL
EUCTR2014-002569-32-NL进行中(未招募)不适用

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

Academic Medical Center0 个研究点开始时间: 2015年4月29日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Male

入选标准

  • 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
  • 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

排除标准

  • 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

研究者

发起方
Academic Medical Center

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