A clinical trial to evaluate the impact of broadly neutralizing antibody VRC01 on HIV viral reservoir and maintenance of suppression in a cohort of early-treated children in Botswana

双重bNAb治疗儿童研究（“Tatelo”）是一项正在进行的I/II期多地点临床试验

The Dual bNAb Treatment in Children Study (“Tatelo”) is an ongoing phase I/II, multi-site clinical trial of dual treatment with two broadly neutralizing monoclonal antibodies (bNAbs), VRC01LS and 10-1074, offered to HIV-1 infected virally suppressed children. The study is evaluating the efficacy of dual bNAbs for maintaining viral suppression in the absence of ART among virally suppressed HIV-infected children who started standard ART within 96 hours of birth (or soon after intrapartum infection). All children in the Tatelo Study were recruited from the Early Infant Treatment (EIT) study (U01AI114235), and have been followed from birth with frequent assessments of their clinical, virologic and immunologic characteristics. Children who received at least 96 weeks of ART and met virologic entry criteria were offered enrollment into the Tatelo Study. The intervention consisted of two PK and safety phases (single and then dual bNAbs), followed by the main study intervention (dual bNAbs plus ART for at least 8 weeks, then dual bNAbs alone for up to 24 weeks), and then a follow-up period when children were returned to ART alone. The study is designed to evaluate three possible benefits of dual bNAb therapy in HIV-1-infected children: 1) to determine the duration of virologic control that can be maintained with dual bNAb treatment following early ART, providing proof-of-concept that bNAbs may serve as a possible alternative to standard ART in children with low viral reservoirs; 2) to investigate whether bNAb therapy is associated with changes in the size and/or the cellular or clonal composition of residual viral reservoirs, which will be highly informative for developing strategies to limit viral persistence and to destabilize viral reservoir homeostasis in pediatric patients; and 3) to evaluate whether treatment with bNAbs is associated with qualitative or quantitative changes in innate or adaptive antiviral immune responses, and if it facilitates the development of an antiviral immune profile that can enable spontaneous post-treatment viral control.