NCT05154513

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 163 (actual)
• Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• HIV Infection

Interventions

Type	Name	Description
OTHER	Cohort 1	No intervention provided in this study

Timeline

• Start date: 2022-02-02
• Primary completion: 2025-07-30
• Completion: 2025-07-30
• First posted: 2021-12-13
• Last updated: 2026-01-13

Locations

28 sites across 11 countries: United States, Botswana, Brazil, Haiti, Kenya, Malawi, South Africa, Tanzania, Thailand, Uganda, Zimbabwe