An observational study in HIV Infection, sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group. Completed at 28 sites in 11 countries. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group · Observational
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 163 is below the median of 200 across 781 observational studies indexed under HIV Infections.
Browse HIV Infections studies →International Maternal Pediatric Adolescent AIDS Clinical Trials Group is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Cohort 1
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
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)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual participant data that underlie results in the publication, after deidentification.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
Access criteria: With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network. For what types of analyses? To achieve aims in the proposal approved by the IMPAACT Network. By what mechanism will data be made available? Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/resources/study-proposals.htm. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.
Ran from Feb 2022 to primary completion in Jul 2025, 41 months.
Of 187 non-industry observational studies under HIV Infections, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's 41 months is above that.
Counting every sponsor, half of 201 studies reached it within 38 months; a quarter within 16 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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International Maternal Pediatric Adolescent AIDS Clinical Trials Group