Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV
NCT ID: NCT05154513
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
163 participants
OBSERVATIONAL
2022-02-02
2025-07-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Cohort 1
No intervention provided in this study
Interventions
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Cohort 1
No intervention provided in this study
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Mental Health (NIMH)
NIH
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Shaun Barnabas, MD, PhD
Role: STUDY_CHAIR
University of Stellenbosch
Samantha Fry, MD, MMed
Role: STUDY_CHAIR
University of Stellenbosch
Julia Rosebush, DO, FAAP
Role: STUDY_CHAIR
University of Chicago
Locations
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David Geffen School of Medicine at UCLA (CRS 5112)
Los Angeles, California, United States
University of Colorado (5052)
Aurora, Colorado, United States
5055, South Florida CDTC Fort Lauderdale Clinical Research Site
Fort Lauderdale, Florida, United States
Univ of Miami Pediatric/Perinatal HIV/AIDS (5127)
Miami, Florida, United States
5030, Emory University School of Medicine Clinical Research Site
Atlanta, Georgia, United States
5128, Texas Children's Hospital Clinical Research Site
Houston, Texas, United States
Gaborone CRS 12701
Gaborone, , Botswana
Molepolole Prevention/Treatment Trials CRS 12702
Molepolole, , Botswana
School of Medicine, University of Minas Gerais - FUNDEP (5073)
Belo Horizonte, , Brazil
5071, Instituto de Puericultura e Pediatria Martagao Gesteira Clinical Research Site
Rio de Janeiro, , Brazil
Hospital dos Servidores Rio de Janeiro
Rio de Janeiro, , Brazil
Hospital Geral De Nova Igaucu (5097)
Rio de Janeiro, , Brazil
Ribeirao Preto Medical School, University of Sao Paulo (5074)
São Paulo, , Brazil
Les Centres GHESKIO (30022)
Port-au-Prince, , Haiti
5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center Kericho Clinical Research Site
Kericho, , Kenya
College of Med. JHU CRS (30301)
Blantyre, , Malawi
University of North Carolina Lilongwe (12001)
Lilongwe, , Malawi
Soweto IMPAACT CRS (8052)
Johannesburg, Gauteng, South Africa
30300, Umlazi Clinical Research Site
Durban, , South Africa
8051, Wits RHI Shandukani Research Centre Clinical Research Site
Johannesburg, , South Africa
Family Clinical Research Unit (FAM-CRU) CRS (8950)
Tygerberg Hills, , South Africa
Kilimanjaro Christian Medical Centre (5118)
Moshi, , Tanzania
Siriraj Hospital Mahidol University CRS (5115)
Bangkok, Ratchathewi, Thailand
Chiang Rai Regional Hospital (5116)
Chiang Rai, , Thailand
31798, Baylor-Uganda Clinical Research Site
Kampala, , Uganda
Seke North CRS 30306
Chitungwiza, , Zimbabwe
St. Mary's CRS 30303
Chitungwiza, , Zimbabwe
Harare Family Care (31890)
Harare, , Zimbabwe
Countries
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Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Other Identifiers
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HHSN275201800001I
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IMPAACT 2028
Identifier Type: -
Identifier Source: org_study_id
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