The role of Home packs of HIV Post-Exposure Prophylaxis for sexual exposure (PEPSE) to improve the speed and appropriate uptake of PEPSE in high risk individuals - HOME PEPSE

Guy's & St. Thomas' NHS Foundation Trust0 个研究点目标入组 140 人开始时间: 2015年4月8日最近更新: 2018年4月30日

适应症

试验速览

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•1. Male gender at birth, age =18 years
•2. HIV negative by a routinely used assay within 4 weeks prior to or on the day of randomization
•3. Willing and able to provide written informed consent
•4.And any one of:
•a.condomless anal sex with a male on >1 occasion within the 90 days prior to randomization
•b.bacterial sexually transmitted infection (STI) within the 90 days prior to randomization
•c.use of PEPSE in the 12 months prior to randomization following possible exposure to HIV through unprotected anal intercourse (UAI) with a male.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 140
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 140

•1. An acute viral illness that could be due to HIV seroconversion
•2. Hypersensitivity to active substance
•3. allergic to soy or peanuts
•4. concomitant use of antihypertensive agents
•5. history of postural hypotension
•6. known hepBsAg positive
•7. current participation in a HIV PrEP or PEPSE study
•8. Any other active clinically significant condition, or findings during screening medical history or examination, or abnormality on screening laboratory blood tests that would, in the opinion of the investigator, compromise the patient’s safety or outcome in the trial.

发起方

Guy's & St. Thomas' NHS Foundation Trust