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

NCT05154513 | Completed

• 3 other identifiers: IMPAACT 20285UM1AI068632-19HHSN275201800001I
• Study Type: observational
• Target: 163
• Locations: 11 countries
• Sites: 28

Brief 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.

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (15)

• 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)

Study Arms (1)

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

Interventions

Cohort 1 OTHER

No intervention provided in this study

Cohort 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• International Maternal Pediatric Adolescent AIDS Clinical Trials Group: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (28)

David Geffen School of Medicine at UCLA (CRS 5112)

Los Angeles, California, 90095, United States

Location

University of Colorado (5052)

Aurora, Colorado, 80045, United States

Location

5055, South Florida CDTC Fort Lauderdale Clinical Research Site

Fort Lauderdale, Florida, 33316, United States

Location

Univ of Miami Pediatric/Perinatal HIV/AIDS (5127)

Miami, Florida, 33136, United States

Location

5030, Emory University School of Medicine Clinical Research Site

Atlanta, Georgia, 30322, United States

Location

5128, Texas Children's Hospital Clinical Research Site

Houston, Texas, 77030, United States

Location

Gaborone CRS 12701

Gaborone, Botswana

Location

Molepolole Prevention/Treatment Trials CRS 12702

Molepolole, Botswana

Location

School of Medicine, University of Minas Gerais - FUNDEP (5073)

Belo Horizonte, Brazil

Location

5071, Instituto de Puericultura e Pediatria Martagao Gesteira Clinical Research Site

Rio de Janeiro, Brazil

Location

Hospital dos Servidores Rio de Janeiro

Rio de Janeiro, Brazil

Location

Hospital Geral De Nova Igaucu (5097)

Rio de Janeiro, Brazil

Location

Ribeirao Preto Medical School, University of Sao Paulo (5074)

São Paulo, Brazil

Location

Les Centres GHESKIO (30022)

Port-au-Prince, Haiti

Location

5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center Kericho Clinical Research Site

Kericho, Kenya

Location

College of Med. JHU CRS (30301)

Blantyre, Malawi

Location

University of North Carolina Lilongwe (12001)

Lilongwe, Malawi

Location

Soweto IMPAACT CRS (8052)

Johannesburg, Gauteng, South Africa

Location

30300, Umlazi Clinical Research Site

Durban, South Africa

Location

8051, Wits RHI Shandukani Research Centre Clinical Research Site

Johannesburg, South Africa

Location

Family Clinical Research Unit (FAM-CRU) CRS (8950)

Tygerberg Hills, South Africa

Location

Kilimanjaro Christian Medical Centre (5118)

Moshi, Tanzania

Location

Siriraj Hospital Mahidol University CRS (5115)

Bangkok, Ratchathewi, 10700, Thailand

Location

Chiang Rai Regional Hospital (5116)

Chiang Rai, Thailand

Location

31798, Baylor-Uganda Clinical Research Site

Kampala, Uganda

Location

Seke North CRS 30306

Chitungwiza, Zimbabwe

Location

St. Mary's CRS 30303

Chitungwiza, Zimbabwe

Location

Harare Family Care (31890)

Harare, Zimbabwe

Location

Biospecimen

Retention: SAMPLES WITH DNA

The following specimens will be collected: HIV-1 RNA PCR, HIV-1 DNA ddPCR, CD4+ and CD8+ cell counts and percentages, HIV-1 antibody, Serum, plasma, and peripheral blood mononuclear cell (PBMC) storage, ARV resistance testing if clinically indicated. If child is three years of age or older, collect nasopharyngeal and rectal swabs for storage.

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• 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 CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: December 13, 2021
• Study Start: February 2, 2022
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

MA (2); ZI (3); BR (5); BO (2); TA (1); UG (1); HA (1); KE (1); US (6); ZA (4); TH (2)