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

NCT05154513

CompletedN/A

Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Conditions: HIV Infection

Interventions: Cohort 1

Countries: United States, Botswana, Brazil, Haiti, Kenya, Malawi, South Africa, Tanzania

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 overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (28)
  • Los Angeles, California, United States
  • Aurora, Colorado, United States
  • Fort Lauderdale, Florida, United States
  • Miami, Florida, United States
  • Atlanta, Georgia, United States
  • Houston, Texas, United States
  • Gaborone, Botswana
  • Molepolole, Botswana
  • Belo Horizonte, Brazil
  • Rio de Janeiro, Brazil
  • Rio de Janeiro, Brazil
  • Rio de Janeiro, Brazil
  • São Paulo, Brazil
  • Port-au-Prince, Haiti
  • Kericho, Kenya
  • Blantyre, Malawi
  • Lilongwe, Malawi
  • Johannesburg, Gauteng, South Africa
  • Durban, South Africa
  • Johannesburg, South Africa
  • Tygerberg Hills, South Africa
  • Moshi, Tanzania
  • Bangkok, Ratchathewi, Thailand
  • Chiang Rai, Thailand
  • Kampala, Uganda
  • Chitungwiza, Zimbabwe
  • Chitungwiza, Zimbabwe
  • Harare, Zimbabwe