跳至主要内容
临床试验/EUCTR2016-005078-37-GR
EUCTR2016-005078-37-GR进行中(未招募)1 期

Public health targeting of PrEP at HIV positives’ bridging networks

Hellenic Scientific Society for the Study of AIDS and Sexually Transmitted Diseases0 个研究点目标入组 100 人开始时间: 2017年3月29日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
100

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

入选标准

  • 1. Born to male gender, age 18 years or more.
  • 2. Documented negative HIV antibody test(s) immediately before starting PrEP medication (up until 3 days before commencement of therapy).
  • 3. Completed screen for STIs (syphilis, gonorrhoea, chlamydia).
  • 4. Confirm that the patient is at substantial, ongoing, high risk for acquiring HIV infection in the past 6 months:
  • oPatients with sexual (MSM, MSMTF) or intravenous drug use risks for acquiring HIV should be considered for starting the PrEP medication.
  • Sexual risk includes (1) condomless anal sex with =2 male or transgender female partners; (2) =2 episodes of anal sex with at least 1 HIV-infected partner; or (3) sex with a male or transgender female partner and self-reported history of syphilis, rectal gonorrhoea, or rectal chlamydia.
  • 5. Confirm that the patient’s” calculated creatinine clearance is greater than or equal to 60 mL/minute (via Cockcroft-Gault formula).
  • 6. Willing and able to provide written informed consent.
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1. An acute viral illness that could be due to a primary HIV infection syndrome.
  • 2. Any contraindications to Truvada® according to the current package insert.
  • 3. Treatment for hepatitis B infection, ongoing or programmed.
  • 4. Administration (current or expected) of a treatment that may be toxic to the kidneys (long-term anti-inflammatory use).
  • 5. Serious disease which could require a treatment that could disrupt the compliance to PrEP.
  • 6. Participation in other interventional clinical trials 30 days prior to enrolment in the present clinical study.
  • 7. Inability or unwillingness to comply to study protocol requirement adjunct to primary objectives.

研究者

发起方
Hellenic Scientific Society for the Study of AIDS and Sexually Transmitted Diseases

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