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:
相关药物
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
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