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

Gilead Sciences, Inc.0 个研究点目标入组 5,000 人开始时间: 2016年9月14日最近更新: 2021年4月5日

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•Subjects must be at high risk of sexual acquisition of HIV and 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

•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 A, B or C or evidence of chronic hepatitis B infection. Subjects found to be susceptible to HBV infection should be referred for HBV vaccination. Subjects found to be positive for HCV at screening must not have active infection or must have completed treatment and achieved a sustained virologic response.
•4) Need for continued use of any contraindicated concomitant medications
•5) Have an implanted defibrillator or pacemaker
•6) Have a history of osteoporosis or bone fragility fractures
•7) Current alcohol or substance abuse judged by the Investigator to be problematic such that it potentially interferes with subject study compliance
•8) Grade 3 or Grade 4 proteinuria or glycosuria that is unexplained or not clinically manageable
•9) 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
•10) Have received investigational agents for the treatment or prevention of HIV-1 infection in the 30 days prior to screening
•11) Participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial

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