# HIV Exposed Uninfected Infant Cohort Study

> **NIH NIH R01** · BOSTON UNIVERSITY MEDICAL CAMPUS · 2020 · $1,119,497

## Abstract

Project Summary/Abstract
Successful implementation of mother-to-child-transmission prevention programs has decreased
perinatal HIV infections from 500,000 to 150,000 cases per year in the last decade. But it is now
evident that this has created a large and expanding number of HIV-exposed but uninfected infants
(HEU) who have more morbidity and mortality than their HIV-unexposed (HU) counterparts. Some
estimate that over 1 million children per year, or 30% of all births in some areas, are HEU children.
However, nearly all of the available evidence of these adverse clinical outcomes for HEU comes
from less rigorous cross sectional or retrospective studies, and the few prospectively followed
birth cohorts reporting clinical outcomes nearly all date from before the Option B+ era of combined
ART (cART) recommended for all HIV-infected pregnant women. It is unknown whether the
increased disease burden of HEU has been diminished by cART. The preponderance of current
evidence suggests that the immune systems of HEU children differ in fundamental ways from HU
children. However, the clinical importance of these differences is far less clear. To date, none of
these immune alterations have been correlated with clinical outcome. The goal of HEUICS is to
determine the relationship between HEU status, maternal/infant risk factors and infant clinical
outcomes. We also propose to investigate 3 plausible determinants of altered neonatal and early
infant immune dysfunction: maternal viral load, cART exposure type and duration, and fetal
exposure to maternal immune activation (IA). Our overall goals are to determine: 1) if a meaningful
increase in morbidity and/or mortality exists among HEU infants by 6 months of age despite
maternal cART during pregnancy, compared with a similar cohort of HIV-unexposed children
(SA1); 2) the degree of IA among pregnant women on cART and its association with infant clinical
outcome (SA2) and; 3) the association of IA with normal and abnormal responses of the early
infant cellular immune system (SA3). We will enroll 1500 pregnant women with and without HIV
and follow the mother-infant pairs through 6 months of age, the window during which infant
mortality rates are highest. Maternal IA status will be determined during the last trimester or at
delivery. Outcomes assessed will be morbidity (infections, sick visits, hospitalization frequency
and length) and mortality. Predictive clinical and laboratory risk factors of increased HEU
morbidity and mortality will be sought. We will enroll a nested subset of 130 mothers with high
and low levels of IA and compare infant innate immune makers that correlate with maternal IA.
Infants will be followed through 6 months of age to assess their early infant disease burden.
1! !

## Key facts

- **NIH application ID:** 9985985
- **Project number:** 5R01HD094650-03
- **Recipient organization:** BOSTON UNIVERSITY MEDICAL CAMPUS
- **Principal Investigator:** Donald M Thea
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,119,497
- **Award type:** 5
- **Project period:** 2018-09-17 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9985985

## Citation

> US National Institutes of Health, RePORTER application 9985985, HIV Exposed Uninfected Infant Cohort Study (5R01HD094650-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9985985. Licensed CC0.

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