A Demonstration Project of Antiretroviral-based HIV-1 Prevention Among High-risk HIV-1 Serodiscordant Couples in Nigeria

ational Agency for the Control of AIDS0 个研究点目标入组 600 人开始时间: 2016年4月24日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•For heterosexual couples:
•1). Sexually active (defined as having had vaginal intercourse at least 6 times in the previous three months)
•2). Willing to enter the study as a couple and intending to remain as a couple for the next 12 months
•3). Has not been on PrEP medication prior to enrollment in study
•For HIV-1 uninfected members of the couple (partner participants):
•1). Able and willing to provide written informed consent
•2). HIV-1 uninfected based on negative HIV-1 rapid tests, both at study screening and at the enrolment visit
•3).Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance ¿60 mL/min
•4). Not currently pregnant or breastfeeding
•5).Not currently enrolled in an HIV-1 prevention clinical trial
•6). Not currently using PrEP
•7). Enrolment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator
•For HIV-1 infected members of the couple (index participants):
•1) Able and willing to provide written informed consent
•2). HIV-1 infected based on positive rapid HIV-1 tests, according to national algorithm
•3). No history of WHO stage III or IV conditions
•4). Not currently using ART
•5). Currently using ART but viral load still higher than 5,000 copies/ml
•6). Not currently enrolled in an HIV-1 treatment study.
•7). Current pregnancy or breastfeeding do not disqualify a candidate who is infected.

发起方

ational Agency for the Control of AIDS