Clinical trial NCT05154513: Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV
Official title: Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HIV Infection
Lead sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute of Mental Health (NIMH)
First posted: 2021-12-13
Enrollment: 163
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

Detailed 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.

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

Primary outcomes:
measure: Clinical Outcome Measures - Weight measured in kg
timeFrame: At enrollment, at participant study completion (up until 7 years)
measure: Clinical Outcome Measures - Height measured in cm
timeFrame: At enrollment, at participant study completion (up until 7 years)
measure: Clinical Outcome Measures - Weight-for-height Z score
timeFrame: At enrollment, at participant study completion (up until 7 years)
measure: Clinical Outcome Measures - Head circumference measured in cm
timeFrame: At birth, 24 months of age
measure: Clinical Outcome Measures - Head circumference-for-age Z score
timeFrame: At birth, 24 months of age
measure: Clinical Outcome Measures - Cumulative incidence of WHO clinical Stage 3 or Stage 4 conditions
timeFrame: At enrollment, at participant study completion (up until 7 years)
measure: 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
timeFrame: At enrollment, at participant study completion (up until 7 years)
measure: Clinical Outcome Measures - Cumulative incidence of other medical conditions of interest
timeFrame: At enrollment, at participant study completion (up until 7 years)
measure: Clinical Outcome Measures - Cumulative incidence of mortality
timeFrame: At study participant completion (up until 7 years)
measure: Immunologic Outcome Measures - CD4+ cell counts and percentages
timeFrame: At enrollment, at participant study completion (up until 7 years)
measure: Immunologic Outcome Measures - CD8+ cell counts and percentages
timeFrame: At enrollment, at participant study completion (up until 7 years)
measure: Immunologic Outcome Measures - HIV-1 antibody status
timeFrame: At enrollment, at participant study completion (up until 7 years)
measure: Virologic Outcome Measures - HIV-1 RNA in plasma
timeFrame: At enrollment, at participant study completion (up until 7 years)
measure: Virologic Outcome Measures - HIV-1 DNA concentration in PBMCs
timeFrame: At enrollment, at participant study completion (up until 7 years)
measure: Virologic Outcome Measures - HIV-1 ARV resistance mutations
timeFrame: At enrollment, at participant study completion (up until 7 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA (CRS 5112)
state: California
city: Aurora
country: United States
facility: University of Colorado (5052)
state: Colorado
city: Fort Lauderdale
country: United States
facility: 5055, South Florida CDTC Fort Lauderdale Clinical Research Site
state: Florida
city: Miami
country: United States
facility: Univ of Miami Pediatric/Perinatal HIV/AIDS (5127)
state: Florida
city: Atlanta
country: United States
facility: 5030, Emory University School of Medicine Clinical Research Site
state: Georgia
city: Houston
country: United States
facility: 5128, Texas Children's Hospital Clinical Research Site
state: Texas
city: Gaborone
country: Botswana
facility: Gaborone CRS 12701
city: Molepolole
country: Botswana
facility: Molepolole Prevention/Treatment Trials CRS 12702
city: Belo Horizonte
country: Brazil
facility: School of Medicine, University of Minas Gerais - FUNDEP (5073)
city: Rio De Janeiro
country: Brazil
facility: 5071, Instituto de Puericultura e Pediatria Martagao Gesteira Clinical Research Site
city: Rio De Janeiro
country: Brazil
facility: Hospital dos Servidores Rio de Janeiro
city: Rio de Janeiro
country: Brazil
facility: Hospital Geral De Nova Igaucu (5097)
city: Sao Paulo
country: Brazil
facility: Ribeirao Preto Medical School, University of Sao Paulo (5074)
city: Port-au-Prince
country: Haiti
facility: Les Centres GHESKIO (30022)
city: Kericho
country: Kenya
facility: 5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center Kericho Clinical Research Site
city: Blantyre
country: Malawi
facility: College of Med. JHU CRS (30301)
city: Lilongwe
country: Malawi
facility: University of North Carolina Lilongwe (12001)
city: Johannesburg
country: South Africa
facility: Soweto IMPAACT CRS (8052)
state: Gauteng
city: Durban
country: South Africa
facility: 30300, Umlazi Clinical Research Site
city: Johannesburg
country: South Africa
facility: 8051, Wits RHI Shandukani Research Centre Clinical Research Site
city: Tygerberg Hills
country: South Africa
facility: Family Clinical Research Unit (FAM-CRU) CRS (8950)
city: Moshi
country: Tanzania
facility: Kilimanjaro Christian Medical Centre (5118)
city: Bangkok
country: Thailand
facility: Siriraj Hospital Mahidol University CRS (5115)
state: Ratchathewi
city: Chiang Rai
country: Thailand
facility: Chiang Rai Regional Hospital (5116)
city: Kampala
country: Uganda
facility: 31798, Baylor-Uganda Clinical Research Site
city: Chitungwiza
country: Zimbabwe
facility: Seke North CRS 30306
city: Chitungwiza
country: Zimbabwe
facility: St. Mary's CRS 30303
city: Harare
country: Zimbabwe
facility: Harare Family Care (31890)
Study officials:
affiliation: University of Stellenbosch
name: Shaun Barnabas, MD, PhD
role: STUDY_CHAIR
affiliation: University of Stellenbosch
name: Samantha Fry, MD, MMed
role: STUDY_CHAIR
affiliation: University of Chicago
name: Julia Rosebush, DO, FAAP
role: STUDY_CHAIR
References: