PER-053-16招募中未知

A PHASE 2B/3 DOUBLE BLIND SAFETY AND EFFICACY STUDY OF INJECTABLE CABOTEGRAVIR COMPARED TO DAILY ORAL TENOFOVIR DISOPROXIL FUMARATE/EMTRICITABINE (TDF/FTC), FOR PRE-EXPOSURE PROPHYLAXIS IN HIVUNINFECTED CISGENDER MEN AND TRANSGENDER WOMEN WHO HAVE SEX WITH ME

INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,0 个研究点目标入组 0 人开始时间: 2017年3月20日最近更新: 2024年8月20日

研究概览

暂无简介。

•Men who have sex with men and Transgender women ≥ 18 years; Willing to provide informed consent for the study; At high risk for sexually acquiring HIV infection based self-report; In general good health, as evidenced by laboratory values, which must be from specimens obtained within 45 days prior to study enrollment; HIV uninfected, based on HIV test results; No medical condition that, in the opinion of the study investigator, would interfere with the conduct of the study; Willing to undergo all required study procedures

•One or more reactive or positive HIV test result; Active or recent use of any illicit intravenous drugs in the last 90 days prior to enrollment; Co-enrollment in any other interventional research study; Past or current participation in HIV vaccine trial. An exception will be made for participants that can provide documentation of receipt of placebo (not active arm); Clinically significant cardiovascular disease; Inflammatory skin conditions that compromise the safety of intramuscular (IM) injections, per the discretion of the Investigator; Mild skin conditions may not be exclusionary at the discretion of the Investigator; Has a tattoo or other dermatological condition overlying the buttock region which may interfere with interpretation of injection site reactions; Current or chronic history of liver disease or known hepatic or biliary abnormalities; Coagulopathy which would contraindicate IM injection; Active or planned use of prohibited medications as described in the Investigator’s Brochure; Known or suspected allergy to study product components (active or placebo); Surgically-placed buttock implants, per self-report; Alcohol or substance use that would jeopardize the safety of the participant on study; History of seizure disorder, per self-report

发起方

INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,