ong-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition

ViiV Healthcare UK Limited0 个研究点目标入组 55 人开始时间: 2023年10月10日最近更新: 2024年4月29日

试验速览

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•1. Participants must be currently enrolled and ongoing in one of the following studies: HPTN 083, HPTN 084, HPTN 083 and HPTN 084 adolescent and pregnancy sub-studies. Participants who have permanently withdrawn from prior CAB PrEP studies cannot enroll into this study.
•2. Evidence of continued benefit (HIV negative and at risk) from CAB LA during participation in the parent study/sub-study.
•3. Participants must have a nonreactive HIV test at Screening (rapid test, antigen/antibody test and HIV-1 RNA from the parent study/sub-study) and Day 1 (a rapid test and HIV Immunoassay [Antigen/Antibody test]).
•4. Males and Females: All participants who are engaging in sexual activity should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of acquiring HIV and other STIs.
•5. Participant or caregiver is able and willing to provide signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

•1. Participants who are currently enrolled in the eligible studies on the TDF/FTC arm are not eligible to enroll into this study. Participants receiving short-term oral TDF/FTC bridging may be enrolled following consultation with the Medical Monitor.

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