EUCTR2016-001399-31-ES进行中（未招募）1 期
A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex with Men and Are At Risk of HIV-1 Infection
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
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
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
- •1) HIV-1 negative status
- •2) MSM or TGW (male at birth) who have at least one of the following:
- •a) condomless anal intercourse with at least two unique male partners in the past 12 weeks (partners must be either HIV-infected or of unknown HIV status)
- •b) documented history of syphilis in the past 24 weeks
- •c) documented history of rectal gonorrhea or chlamydia in the past 24 weeks
- •3) Age = 18 years
- •4) Estimated GFR = 60 mL/min according to the Cockcroft-Gault formula for creatinine clearance
- •5) Adequate liver and hematologic function
- •6) Willing and able to comply with study procedures
- •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 4900
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
- •1) Known hypersensitivity to the IMP, the metabolites, or formulation excipient
- •2) Have a suspected or known active, serious infection(s)
- •3) Acute viral hepatitis or evidence of chronic hepatitis B infection. Subjects found to be susceptible to HBV infection should be referred for HBV vaccination
- •4) Evidence or known history of hepatitis C infection
- •5) Need for continued use of any contraindicated concomitant medications
- •6) Have an implanted defibrillator or pacemaker
- •7) Have a history of osteoporosis or bone fragility fractures
- •8) Current alcohol or substance abuse judged by the Investigator to be problematic such that it potentially interferes with subject study compliance
- •9) Grade 3 or Grade 4 proteinuria or glycosuria that is unexplained or not clinically manageable
- •10) Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements
- •11) In the 30 days prior to screening have received F/TDF or any other approved or investigational agent for the prevention of HIV-1 infection or during the trial would be receiving any other approved or investigational agents for the treatment/prevention of HIV-1 infection
- •12) Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial
研究者
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