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.
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.
Study Type
OBSERVATIONAL
Enrollment
163
No intervention provided in this study
Clinical Outcome Measures - Weight measured in kg
Median and interquartile range; to characterize long-term clinical profile
Time frame: At enrollment, at participant study completion (up until 7 years)
Clinical Outcome Measures - Height measured in cm
Median and interquartile range; to characterize long-term clinical profile
Time frame: At enrollment, at participant study completion (up until 7 years)
Clinical Outcome Measures - Weight-for-height Z score
Median and interquartile range, % of participants with Z scores corresponding to mild, moderate, or severe malnutrition
Time frame: At enrollment, at participant study completion (up until 7 years)
Clinical Outcome Measures - Head circumference measured in cm
Median and interquartile range; to characterize long-term clinical profile
Time frame: At birth, 24 months of age
Clinical Outcome Measures - Head circumference-for-age Z score
Median and interquartile range; to characterize long-term clinical profile
Time frame: At birth, 24 months of age
Clinical Outcome Measures - Cumulative incidence of WHO clinical Stage 3 or Stage 4 conditions
% of patients with outcome; to characterize long-term clinical profile
Time frame: At enrollment, at participant study completion (up until 7 years)
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
% of patients with outcome; to characterize long-term clinical profile
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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
...and 18 more locations
Time frame: At enrollment, at participant study completion (up until 7 years)
Clinical Outcome Measures - Cumulative incidence of other medical conditions of interest
% of patients with outcome; to characterize long-term clinical profile
Time frame: At enrollment, at participant study completion (up until 7 years)
Clinical Outcome Measures - Cumulative incidence of mortality
% of patients with outcome; to characterize long-term clinical profile
Time frame: At study participant completion (up until 7 years)
Immunologic Outcome Measures - CD4+ cell counts and percentages
Median and interquartile range; to characterize long-term immunologic profile
Time frame: At enrollment, at participant study completion (up until 7 years)
Immunologic Outcome Measures - CD8+ cell counts and percentages
Median and interquartile range; to characterize long-term immunologic profile
Time frame: At enrollment, at participant study completion (up until 7 years)
Immunologic Outcome Measures - HIV-1 antibody status
% of participants with negative serostatus
Time frame: At enrollment, at participant study completion (up until 7 years)
Virologic Outcome Measures - HIV-1 RNA in plasma
% of participants with HIV-1 RNA below the limit of detection of the assay among participants with quantifiable HIV-1 RNA, median and interquartile range
Time frame: At enrollment, at participant study completion (up until 7 years)
Virologic Outcome Measures - HIV-1 DNA concentration in PBMCs
% of participants with HIV-1 DNA below the limit of detection of the assay among participants with quantifiable HIV-1 DNA, median and interquartile range
Time frame: At enrollment, at participant study completion (up until 7 years)
Virologic Outcome Measures - HIV-1 ARV resistance mutations
% of participants with resistance mutations
Time frame: At enrollment, at participant study completion (up until 7 years)