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

Last updated: March 11, 2024
Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aids And Aids Related Infections

Hiv/aids

Hiv Infections

Treatment

Cohort 1

Clinical Study ID

NCT05154513
IMPAACT 2028
UM1AI068632
UM1AI106716
UM1AI068616
HHSN275201800001I
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participated in one of the parent studies
  • Confirmed HIV-1 infection based on documented nucleic acid testing of two bloodsamples collected at different time points
  • Received early treatment for HIV-1 infection, defined as treatment with at least threeARV 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 atleast 24 months of follow-up
  • Parent or guardian is willing and able to provide written informed consent for child'sstudy participation and, when applicable per institutional review board/ethicscommittee (IRB/EC) policies and procedures, child is willing and able to providewritten assent for study participation

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Cohort 1
Phase:
Study Start date:
February 02, 2022
Estimated Completion Date:
November 30, 2027

Study 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.

Connect with a study center

  • Gaborone CRS 12701

    Gaborone,
    Botswana

    Site Not Available

  • Molepolole Prevention/Treatment Trials CRS 12702

    Molepolole,
    Botswana

    Site Not Available

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

    Belo Horizonte,
    Brazil

    Active - Recruiting

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

    Rio De Janeiro,
    Brazil

    Site Not Available

  • Hospital dos Servidores Rio de Janeiro

    Rio De Janeiro,
    Brazil

    Active - Recruiting

  • Hospital Geral De Nova Igaucu (5097)

    Rio de Janeiro,
    Brazil

    Active - Recruiting

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

    Sao Paulo,
    Brazil

    Active - Recruiting

  • Les Centres GHESKIO (30022)

    Port-au-Prince,
    Haiti

    Site Not Available

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

    Kericho,
    Kenya

    Active - Recruiting

  • College of Med. JHU CRS (30301)

    Blantyre,
    Malawi

    Active - Recruiting

  • University of North Carolina Lilongwe (12001)

    Lilongwe,
    Malawi

    Active - Recruiting

  • Soweto IMPAACT CRS (8052)

    Johannesburg, Gauteng
    South Africa

    Active - Recruiting

  • 30300, Umlazi Clinical Research Site

    Durban,
    South Africa

    Active - Recruiting

  • 8051, Wits RHI Shandukani Research Centre Clinical Research Site

    Johannesburg,
    South Africa

    Active - Recruiting

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

    Tygerberg Hills,
    South Africa

    Active - Recruiting

  • Kilimanjaro Christian Medical Centre (5118)

    Moshi,
    Tanzania

    Site Not Available

  • Siriraj Hospital Mahidol University CRS (5115)

    Bangkok, Ratchathewi 10700
    Thailand

    Active - Recruiting

  • Chiang Rai Regional Hospital (5116)

    Chiang Rai,
    Thailand

    Site Not Available

  • 31798, Baylor-Uganda Clinical Research Site

    Kampala,
    Uganda

    Active - Recruiting

  • David Geffen School of Medicine at UCLA (CRS 5112)

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of Southern California (CRS 5048)

    Los Angeles, California 90089
    United States

    Site Not Available

  • University California, San Diego (CRS 4601)

    San Diego, California 92103
    United States

    Active - Recruiting

  • University of Colorado (5052)

    Aurora, Colorado 80045
    United States

    Site Not Available

  • 5055, South Florida CDTC Fort Lauderdale Clinical Research Site

    Fort Lauderdale, Florida 33316
    United States

    Active - Recruiting

  • University of Florida (5051)

    Jacksonville, Florida 32209
    United States

    Site Not Available

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

    Miami, Florida 33136
    United States

    Active - Recruiting

  • 5030, Emory University School of Medicine Clinical Research Site

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Ann & Robert H Lurie Children's Hospital of Chicago (4001)

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Johns Hopkins University NICHD CRS (5092)

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • 32017, Children's Mercy Hospital Clinical Research Site

    Kansas City, Missouri 64108
    United States

    Site Not Available

  • Bronx-Lebanon Hospital Center (CRS 5114)

    Bronx, New York 10457
    United States

    Site Not Available

  • St. Jude Childrens Research Hosp, Memphis (6501)

    Memphis, Tennessee 38105
    United States

    Site Not Available

  • 5128, Texas Children's Hospital Clinical Research Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Seke North CRS 30306

    Chitungwiza,
    Zimbabwe

    Active - Recruiting

  • St. Mary's CRS 30303

    Chitungwiza,
    Zimbabwe

    Active - Recruiting

  • Harare Family Care (31890)

    Harare,
    Zimbabwe

    Active - Recruiting

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