Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV - Trial NCT05154513

Timeline & Enrollment

Primary Outcome

Clinical Outcome Measures - Weight measured in kg,Clinical Outcome Measures - Height measured in cm,Clinical Outcome Measures - Weight-for-height Z score,Clinical Outcome Measures - Head circumference measured in cm,Clinical Outcome Measures - Head circumference-for-age Z score,Clinical Outcome Measures - Cumulative incidence of WHO clinical Stage 3 or Stage 4 conditions,Clinical Outcome Measures - Cumulative incidence of medical conditions that required hospitalization, resulted in persistent or significant disability or incapacity, were life threatening, or resulted in death,Clinical Outcome Measures - Cumulative incidence of other medical conditions of interest,Clinical Outcome Measures - Cumulative incidence of mortality,Immunologic Outcome Measures - CD4+ cell counts and percentages,Immunologic Outcome Measures - CD8+ cell counts and percentages,Immunologic Outcome Measures - HIV-1 antibody status,Virologic Outcome Measures - HIV-1 RNA in plasma,Virologic Outcome Measures - HIV-1 DNA concentration in PBMCs,Virologic Outcome Measures - HIV-1 ARV resistance mutations

Summary

IMPAACT 2028 is an observational prospective study to characterize a cohort of early treated
 children who may participate in future research related to HIV remission or cure. Up to
 approximately 250 participants will be in the study for approximately seven years. No
 intervention is provided in the study.

ICD-10 Classifications