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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infection

Intervention / Treatment
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* Other: Cohort 1


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>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<br>* No intervention provided in this study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome Measures - Weight measured in kg | Median and interquartile range; to characterize long-term clinical profile | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | At enrollment, at participant study completion (up until 7 years) | 
| Immunologic Outcome Measures - HIV-1 antibody status | % of participants with negative serostatus | 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 | 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 | At enrollment, at participant study completion (up until 7 years) | 
| Virologic Outcome Measures - HIV-1 ARV resistance mutations | % of participants with resistance mutations | At enrollment, at participant study completion (up until 7 years) |