HIV InfectionNCT05154513
Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV
An observational study of HIV Infection, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 28 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infection
- What is being tested?
- Cohort 1
- How many people
- 163 participants
- Where
- 28 sitesin 11 countries
- Study dates
- 2 Feb 2022to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
28 sites in 11 countries.
28 sites in 11 countries
United States6 sites
5030, Emory University School of Medicine Clinical Research Site
Atlanta, Georgia, 30322
University of Colorado (5052)
Aurora, Colorado, 80045
5055, South Florida CDTC Fort Lauderdale Clinical Research Site
Fort Lauderdale, Florida, 33316
5128, Texas Children's Hospital Clinical Research Site
Houston, Texas, 77030
David Geffen School of Medicine at UCLA (CRS 5112)
Los Angeles, California, 90095
Univ of Miami Pediatric/Perinatal HIV/AIDS (5127)
Miami, Florida, 33136
Brazil5 sites
School of Medicine, University of Minas Gerais - FUNDEP (5073)
Belo Horizonte
5071, Instituto de Puericultura e Pediatria Martagao Gesteira Clinical Research Site
Rio de Janeiro
Hospital dos Servidores Rio de Janeiro
Rio de Janeiro
Hospital Geral De Nova Igaucu (5097)
Rio de Janeiro
Ribeirao Preto Medical School, University of Sao Paulo (5074)
São Paulo
South Africa4 sites
30300, Umlazi Clinical Research Site
Durban
Soweto IMPAACT CRS (8052)
Johannesburg, Gauteng
8051, Wits RHI Shandukani Research Centre Clinical Research Site
Johannesburg
Family Clinical Research Unit (FAM-CRU) CRS (8950)
Tygerberg Hills
Zimbabwe3 sites
Seke North CRS 30306
Chitungwiza
St. Mary's CRS 30303
Chitungwiza
Harare Family Care (31890)
Harare
Botswana2 sites
Gaborone CRS 12701
Gaborone
Molepolole Prevention/Treatment Trials CRS 12702
Molepolole
Malawi2 sites
College of Med. JHU CRS (30301)
Blantyre
University of North Carolina Lilongwe (12001)
Lilongwe
Thailand2 sites
Siriraj Hospital Mahidol University CRS (5115)
Bangkok, Ratchathewi, 10700
Chiang Rai Regional Hospital (5116)
Chiang Rai
Kenya1 site
5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center Kericho Clinical Research Site
Kericho
About this study
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.
Read the 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.
- Conditions
- HIV Infection
- Being tested
- Cohort 1
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1Other
No intervention provided in this study
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | 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. Receives: Other: Cohort 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome Measures - Weight measured in kg
Median and interquartile range; to characterize long-term clinical profile
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At enrollment, at participant study completion (up until 7 years)
Immunologic Outcome Measures - HIV-1 antibody status
% of participants with negative serostatus
Measured: 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
Measured: 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
Measured: At enrollment, at participant study completion (up until 7 years)
Virologic Outcome Measures - HIV-1 ARV resistance mutations
% of participants with resistance mutations
Measured: At enrollment, at participant study completion (up until 7 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start2 Feb 2022
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Shaun Barnabas, MD, PhD, Study chair, University of StellenboschSamantha Fry, MD, MMed, Study chair, University of StellenboschJulia Rosebush, DO, FAAP, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154513
- Sponsor's protocol ID
- IMPAACT 2028
- Other IDs
- 5UM1AI068632-19, HHSN275201800001I
- Status last verified
- Jan 2026
- First submitted
- 4 Mar 2021
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Clinical, Immunologic, and Virologic Profiles of Children Who Received Early Treatment for HIV
- ClinicalTrials.gov ID
- NCT05154513
- Acronym / sponsor ID
- IMPAACT 2028
- Conditions
- HIV Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials GroupResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Cohort 1Children 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort 1No intervention provided in this study | Other | Cohort 1 |
Primary outcome
Clinical Outcome Measures - Weight measured in kg
Time frame: At enrollment, at participant study completion (up until 7 years)
Median and interquartile range; to characterize long-term clinical profile
Clinical Outcome Measures - Height measured in cm
Time frame: At enrollment, at participant study completion (up until 7 years)
Median and interquartile range; to characterize long-term clinical profile
Clinical Outcome Measures - Weight-for-height Z score
Time frame: At enrollment, at participant study completion (up until 7 years)
Median and interquartile range, % of participants with Z scores corresponding to mild, moderate, or severe malnutrition
Clinical Outcome Measures - Head circumference measured in cm
Time frame: At birth, 24 months of age
Median and interquartile range; to characterize long-term clinical profile
Clinical Outcome Measures - Head circumference-for-age Z score
Time frame: At birth, 24 months of age
Median and interquartile range; to characterize long-term clinical profile
Clinical Outcome Measures - Cumulative incidence of WHO clinical Stage 3 or Stage 4 conditions
Time frame: At enrollment, at participant study completion (up until 7 years)
% of patients with outcome; to characterize long-term clinical profile
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
Time frame: At enrollment, at participant study completion (up until 7 years)
% of patients with outcome; to characterize long-term clinical profile
Clinical Outcome Measures - Cumulative incidence of other medical conditions of interest
Time frame: At enrollment, at participant study completion (up until 7 years)
% of patients with outcome; to characterize long-term clinical profile
Clinical Outcome Measures - Cumulative incidence of mortality
Time frame: At study participant completion (up until 7 years)
% of patients with outcome; to characterize long-term clinical profile
Immunologic Outcome Measures - CD4+ cell counts and percentages
Time frame: At enrollment, at participant study completion (up until 7 years)
Median and interquartile range; to characterize long-term immunologic profile
Immunologic Outcome Measures - CD8+ cell counts and percentages
Time frame: At enrollment, at participant study completion (up until 7 years)
Median and interquartile range; to characterize long-term immunologic profile
Immunologic Outcome Measures - HIV-1 antibody status
Time frame: At enrollment, at participant study completion (up until 7 years)
% of participants with negative serostatus
Virologic Outcome Measures - HIV-1 RNA in plasma
Time frame: At enrollment, at participant study completion (up until 7 years)
% 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
Virologic Outcome Measures - HIV-1 DNA concentration in PBMCs
Time frame: At enrollment, at participant study completion (up until 7 years)
% 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
Virologic Outcome Measures - HIV-1 ARV resistance mutations
Time frame: At enrollment, at participant study completion (up until 7 years)
% of participants with resistance mutations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaun Barnabas, MD, PhD study chair
University of Stellenbosch
Samantha Fry, MD, MMed study chair
University of Stellenbosch
Julia Rosebush, DO, FAAP study chair
University of Chicago
28 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 28 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Brazil, South Africa, Zimbabwe, Botswana and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcome Measures - Weight measured in kg (time frame: At enrollment, at participant study completion (up until 7 years)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.