Early Infant Treatment

描述（由申请人提供）：在HIV感染后不久开始联合抗逆转录病毒治疗（ART）可能会阻止一些婴儿体内潜伏感染细胞的长期蓄水池的播种。我们建议在博茨瓦纳进行一项介入性研究，从出生开始筛查艾滋病毒感染，并立即向受感染的婴儿提供抗逆转录病毒治疗。在抗逆转录病毒治疗开始后24个月，未检测到病毒库的婴儿将接受有控制的治疗中断，并密切评估病毒反弹。我们将把50名艾滋病毒阳性婴儿纳入两个平行的早期治疗队列：30名婴儿在出生72小时内检测出艾滋病毒阳性，并在出生后7天内开始抗逆转录病毒治疗；20名婴儿在出生后72小时内检测出艾滋病毒，但在出生后42天内检测出艾滋病毒阳性，并在出生后56天开始抗逆转录病毒治疗。研究的主要目的是评估早期抗逆转录病毒治疗的安全性和有效性；

DESCRIPTION (provided by applicant): Combination antiretroviral treatment (ART) initiated shortly after HIV infection may prevent seeding of a long-lasting reservoir of latently infected cells in some infants. We propose an interventional study in Botswana to screen for HIV infection from birth and provide immediate ART to infected infants. At 24 months from ART initiation, infants without viral reservoir detection will undergo a controlled treatment interrupton with close evaluation for viral rebound. We will enroll 50 HIV+ infants into two parallel early treatment cohorts: 30 infants who test HIV+ within 72 hours of birth and initiate ART at < 7 days of life, and 20 infants who test HIV- within 72 hours of birth but HIV+ within 42 days of life and initiate ART by 56 days of life. Primary study aims will evaluate safety and efficacy of early ART; virologic and immunologic outcomes with early ART; and the possibility of functional cure (or the dynamics of viral rebound) after ART interruption. In Botswana, an established research infrastructure allows rapid diagnosis of HIV infection and high rates of treatment adherence and follow-up. In Boston, specialized virologic and immunologic testing is available to study viral reservoirs and the immunologic impact of early treatment. This unique collaboration will allow for a detailed investigation of how cellular HIV reservoirs, immune responses, and mechanisms of viral long-term persistence can be manipulated through early ART initiation.