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.

Study Overview

• Status: Completed
• Conditions: HIV Infection
• Intervention / Treatment: Other: Cohort 1

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.

• Study Type: Observational
• Enrollment (Actual): 163

Contacts and Locations

Study Locations

• Botswana
  • Gaborone, Botswana
    • Gaborone CRS 12701
  • Molepolole, Botswana
    • Molepolole Prevention/Treatment Trials CRS 12702
• Brazil
  • Belo Horizonte, Brazil
    • School of Medicine, University of Minas Gerais - FUNDEP (5073)
  • Rio de Janeiro, Brazil
    • Hospital Geral De Nova Igaucu (5097)
  • Rio de Janeiro, Brazil
    • 5071, Instituto de Puericultura e Pediatria Martagao Gesteira Clinical Research Site
  • Rio de Janeiro, Brazil
    • Hospital dos Servidores Rio de Janeiro
  • São Paulo, Brazil
    • Ribeirao Preto Medical School, University of Sao Paulo (5074)
• Haiti
  • Port-au-Prince, Haiti
    • Les Centres GHESKIO (30022)
• Kenya
  • Kericho, Kenya
    • 5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center Kericho Clinical Research Site
• Malawi
  • Blantyre, Malawi
    • College of Med. JHU CRS (30301)
  • Lilongwe, Malawi
    • University of North Carolina Lilongwe (12001)
• South Africa
  • Durban, South Africa
    • 30300, Umlazi Clinical Research Site
  • Johannesburg, South Africa
    • 8051, Wits RHI Shandukani Research Centre Clinical Research Site
  • Tygerberg Hills, South Africa
    • Family Clinical Research Unit (FAM-CRU) CRS (8950)
  • Gauteng
    • Johannesburg, Gauteng, South Africa
      • Soweto IMPAACT CRS (8052)
• Tanzania
  • Moshi, Tanzania
    • Kilimanjaro Christian Medical Centre (5118)
• Thailand
  • Chiang Rai, Thailand
    • Chiang Rai Regional Hospital (5116)
  • Ratchathewi
    • Bangkok, Ratchathewi, Thailand, 10700
      • Siriraj Hospital Mahidol University CRS (5115)
• Uganda
  • Kampala, Uganda
    • 31798, Baylor-Uganda Clinical Research Site
• United States
  • California
    • Los Angeles, California, United States, 90095
      • David Geffen School of Medicine at UCLA (CRS 5112)
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado (5052)
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • 5055, South Florida CDTC Fort Lauderdale Clinical Research Site
    • Miami, Florida, United States, 33136
      • Univ of Miami Pediatric/Perinatal HIV/AIDS (5127)
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • 5030, Emory University School of Medicine Clinical Research Site
  • Texas
    • Houston, Texas, United States, 77030
      • 5128, Texas Children's Hospital Clinical Research Site
• Zimbabwe
  • Chitungwiza, Zimbabwe
    • St. Mary's CRS 30303
  • Chitungwiza, Zimbabwe
    • Seke North CRS 30306
  • Harare, Zimbabwe
    • Harare Family Care (31890)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Children living with perinatally-acquired HIV who received early treatment in IMPAACT network studies or other research studies sponsored by the United States National Institutes of Health.	Other: Cohort 1; No intervention provided in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcome Measures - Weight measured in kg	Median and interquartile range; to characterize long-term clinical profile	At enrollment, at participant study completion (up until 7 years)
Clinical Outcome Measures - Height measured in cm	Median and interquartile range; to characterize long-term clinical profile	At enrollment, at participant study completion (up until 7 years)
Clinical Outcome Measures - Weight-for-height Z score	Median and interquartile range, % of participants with Z scores corresponding to mild, moderate, or severe malnutrition	At enrollment, at participant study completion (up until 7 years)
Clinical Outcome Measures - Head circumference measured in cm	Median and interquartile range; to characterize long-term clinical profile	At birth, 24 months of age
Clinical Outcome Measures - Head circumference-for-age Z score	Median and interquartile range; to characterize long-term clinical profile	At birth, 24 months of age
Clinical Outcome Measures - Cumulative incidence of WHO clinical Stage 3 or Stage 4 conditions	% of patients with outcome; to characterize long-term clinical profile	At enrollment, at participant study completion (up until 7 years)
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	% of patients with outcome; to characterize long-term clinical profile	At enrollment, at participant study completion (up until 7 years)
Clinical Outcome Measures - Cumulative incidence of other medical conditions of interest	% of patients with outcome; to characterize long-term clinical profile	At enrollment, at participant study completion (up until 7 years)
Clinical Outcome Measures - Cumulative incidence of mortality	% of patients with outcome; to characterize long-term clinical profile	At study participant completion (up until 7 years)
Immunologic Outcome Measures - CD4+ cell counts and percentages	Median and interquartile range; to characterize long-term immunologic profile	At enrollment, at participant study completion (up until 7 years)
Immunologic Outcome Measures - CD8+ cell counts and percentages	Median and interquartile range; to characterize long-term immunologic profile	At enrollment, at participant study completion (up until 7 years)
Immunologic Outcome Measures - HIV-1 antibody status	% of participants with negative serostatus	At enrollment, at participant study completion (up until 7 years)
Virologic Outcome Measures - HIV-1 RNA in plasma	% 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	At enrollment, at participant study completion (up until 7 years)
Virologic Outcome Measures - HIV-1 DNA concentration in PBMCs	% 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	At enrollment, at participant study completion (up until 7 years)
Virologic Outcome Measures - HIV-1 ARV resistance mutations	% of participants with resistance mutations	At enrollment, at participant study completion (up until 7 years)

Collaborators and Investigators

• Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Mental Health (NIMH)
• Investigators: Study Chair: Shaun Barnabas, MD, PhD, University of Stellenbosch; Study Chair: Samantha Fry, MD, MMed, University of Stellenbosch; Study Chair: Julia Rosebush, DO, FAAP, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Estimated): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: IMPAACT 2028; HHSN275201800001I (Other Identifier: Eunice Kennedy Shriver National Institute of Child Health and Human Development); 5UM1AI068632-19 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie results in the publication, after deidentification.
• IPD Sharing Time Frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
• IPD Sharing Access Criteria: With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.; For what types of analyses? To achieve aims in the proposal approved by the IMPAACT Network.; By what mechanism will data be made available? Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/resources/study-proposals.htm. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No