Pediatric <scp>NHP</scp> Workshop—“ <scp>NHP</scp> Models for <scp>HIV</scp> Prevention and Treatment: Towards Developing Pediatric Formulations”, New Orleans, <scp>LA</scp> , October 22, 2024: Summary of Proceeding—Session <scp>IV</scp> : Challenges

ABSTRACT Juvenile and infant nonhuman primate models are critical for advancing pediatric HIV prevention and cure research but present unique biological and logistical challenges. Studies in juvenile Rhesus macaque must address seasonal breeding constraints, genetic diversity, limited tissue access, infant rearing complexities and age‐specific drug dosing and anesthesia considerations. Neonatal immune systems differ markedly from adults, exhibiting heightened plasticity, rapid CD4 + T cell turnover and evolving antibody responses, suggesting a narrow window in early life when antiretroviral therapy may limit viral reservoir formation and support durable remission. To improve rigor and reproducibility, structured quality management systems were applied to non‐GxP research, enhancing data integrity, and traceability. In this framework, once‐weekly oral Islatravir provided complete protection against repeated low‐dose vaginal challenge with SIVmac251, preventing viremia, seroconversion, and detectable proviral DNA. Standardized assays, centralized laboratories, and robust statistical design were emphasized to maximize translational impact.