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NCT Number: NCT05154513

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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Gaborone CRS 12701, Gaborone, Botswana

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About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cohort 1

Other

No intervention provided in this study

Primary outcomes

  1. Clinical Outcome Measures - Weight measured in kg

    Time frame: At enrollment, at participant study completion (up until 7 years)

    Median and interquartile range; to characterize long-term clinical profile

  2. Clinical Outcome Measures - Height measured in cm

    Time frame: At enrollment, at participant study completion (up until 7 years)

    Median and interquartile range; to characterize long-term clinical profile

  3. Clinical Outcome Measures - Weight-for-height Z score

    Time frame: At enrollment, at participant study completion (up until 7 years)

    Median and interquartile range, % of participants with Z scores corresponding to mild, moderate, or severe malnutrition

  4. Clinical Outcome Measures - Head circumference measured in cm

    Time frame: At birth, 24 months of age

    Median and interquartile range; to characterize long-term clinical profile

  5. Clinical Outcome Measures - Head circumference-for-age Z score

    Time frame: At birth, 24 months of age

    Median and interquartile range; to characterize long-term clinical profile

  6. Clinical Outcome Measures - Cumulative incidence of WHO clinical Stage 3 or Stage 4 conditions

    Time frame: At enrollment, at participant study completion (up until 7 years)

    % of patients with outcome; to characterize long-term clinical profile

  7. 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

    Time frame: At enrollment, at participant study completion (up until 7 years)

    % of patients with outcome; to characterize long-term clinical profile

  8. Clinical Outcome Measures - Cumulative incidence of other medical conditions of interest

    Time frame: At enrollment, at participant study completion (up until 7 years)

    % of patients with outcome; to characterize long-term clinical profile

  9. Clinical Outcome Measures - Cumulative incidence of mortality

    Time frame: At study participant completion (up until 7 years)

    % of patients with outcome; to characterize long-term clinical profile

  10. Immunologic Outcome Measures - CD4+ cell counts and percentages

    Time frame: At enrollment, at participant study completion (up until 7 years)

    Median and interquartile range; to characterize long-term immunologic profile

  11. Immunologic Outcome Measures - CD8+ cell counts and percentages

    Time frame: At enrollment, at participant study completion (up until 7 years)

    Median and interquartile range; to characterize long-term immunologic profile

  12. Immunologic Outcome Measures - HIV-1 antibody status

    Time frame: At enrollment, at participant study completion (up until 7 years)

    % of participants with negative serostatus

  13. Virologic Outcome Measures - HIV-1 RNA in plasma

    Time frame: At enrollment, at participant study completion (up until 7 years)

    % of participants with HIV-1 RNA below the limit of detection of the assay among participants with quantifiable HIV-1 RNA, median and interquartile range

  14. Virologic Outcome Measures - HIV-1 DNA concentration in PBMCs

    Time frame: At enrollment, at participant study completion (up until 7 years)

    % of participants with HIV-1 DNA below the limit of detection of the assay among participants with quantifiable HIV-1 DNA, median and interquartile range

  15. Virologic Outcome Measures - HIV-1 ARV resistance mutations

    Time frame: At enrollment, at participant study completion (up until 7 years)

    % of participants with resistance mutations

Sponsors and collaborators

Lead sponsor

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Network

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 13, 2021
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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