HIV Infection
Conditions
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.
Interventions
OTHERCohort 1
No intervention provided in this study
Sponsors
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)
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcome Measures - Weight measured in kg | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | At enrollment, at participant study completion (up until 7 years) | % of participants with negative serostatus |
| Virologic Outcome Measures - HIV-1 RNA in plasma | 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 | 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 | At enrollment, at participant study completion (up until 7 years) | % of participants with resistance mutations |
Countries
Botswana, Brazil, Haiti, Kenya, Malawi, South Africa, Tanzania, Thailand, Uganda, United States, Zimbabwe
Outcome results
None listed