Early Infant Treatment

描述(由申请人提供)：艾滋病毒感染后不久开始的联合抗逆转录病毒治疗(ART)可能会防止在一些婴儿中种植长期的潜伏感染细胞。我们建议在博茨瓦纳进行一项干预性研究，从出生起就筛查艾滋病毒感染，并立即为感染的婴儿提供抗逆转录病毒治疗。在ART启动后24个月，没有检测到病毒库的婴儿将接受受控治疗中断，并密切评估病毒反弹。我们将把50名艾滋病毒婴儿纳入两个平行的早期治疗队列：30名婴儿在出生72小时内检测艾滋病毒并在出生后7天开始抗逆转录病毒治疗，20名婴儿在出生72小时内检测艾滋病毒，但在出生42天内开始抗逆转录病毒治疗，并在出生56天开始抗逆转录病毒治疗。主要研究目标是评估早期抗逆转录病毒疗法的安全性和有效性； 早期抗逆转录病毒疗法的病毒学和免疫学结果；以及抗逆转录病毒疗法中断后功能性治愈(或病毒反弹的动力学)的可能性。在博茨瓦纳，已建立的研究基础设施使艾滋病毒感染得到快速诊断，治疗依从率和随访率较高。在波士顿，专门的病毒学和免疫学测试可用于研究病毒库和早期治疗的免疫学影响。这一独特的合作将使我们能够详细研究如何通过早期ART启动来操纵细胞艾滋病毒储存、免疫反应和病毒长期持续的机制。

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.