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

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

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.

This is an observational prospective cohort study characterizing and establishing a biorepository of early treated children who may participate in future research related to HIV remission or cure. Early treatment is defined as treatment with at least three ARV agents from at least two classes of ART initiated within 12 weeks of birth. Within the overall study population, for descriptive and analysis purposes, children who initiated treatment within 48 hours of birth will be classified as having received very early treatment. A subset of children will have received bNAbs as part of their treatment regimens.

Up to approximately 250 children living with HIV who received early treatment in IMPAACT network studies or other research studies sponsored by the US National Institutes of Health (NIH) will be enrolled and followed semi-annually for up to seven years. Clinical, virologic, and immunologic evaluations will be performed semi-annually at each study visit, and specimens will be collected for the study's biorepository for future investigations.

Inclusion Criteria:

• Participated in one of the parent studies
• Confirmed HIV-1 infection based on documented nucleic acid testing of two blood samples collected at different time points
• Received early treatment for HIV-1 infection, defined as treatment with at least three ARV agents from at least two classes of ART, initiated within 12 weeks of birth
• Based on parent or guardian report at entry, child is expected to be available for at least 24 months of follow-up
• Parent or guardian is willing and able to provide written informed consent for child's study participation and, when applicable per institutional review board/ethics committee (IRB/EC) policies and procedures, child is willing and able to provide written assent for study participation

Exclusion Criteria:

• Has any documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe or otherwise interfere with completing study procedures