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

Completed

Conditions studied: HIV Infection

In brief

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.

Key facts

Study ID

NCT05154513

Run by

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

People needed

163

Starts

2022-02-02

Expected to finish

2025-07-30

Last updated by the study team

2026-01-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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