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Monitoring health effects in children born to HIV-infected mothers

Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women

Harvard School of Public Health (HSPH) · NCT01310023

This study is trying to see if children born to mothers with HIV who took medication during pregnancy have any health problems as they grow up.

Quick facts

Study typeObservational
Enrollment5170 (estimated)
SexAll
SponsorHarvard School of Public Health (HSPH) (other)
Locations22 sites (Birmingham, Alabama and 21 other locations)
Trial IDNCT01310023 on ClinicalTrials.gov

What this trial studies

This observational study aims to estimate the incidence of health conditions related to in utero exposure to antiretroviral therapy (ART) among children born to HIV-infected mothers. It will actively monitor children under 12 years of age for various abnormalities potentially linked to ART exposure during pregnancy and the first two months of life. The study will utilize a registry approach to collect clinical and laboratory data, identifying adverse events and significant observations to establish patterns of toxicity. The findings will help address concerns regarding the long-term effects of ART on infants.

Who should consider this trial

Good fit: Ideal candidates include HIV-exposed fetuses greater than or equal to 23 weeks gestation or live infants born after 22 weeks gestation to HIV-infected mothers.

Not a fit: Patients who are HIV-positive infants will not benefit from this study as they will be discontinued and referred for care outside the study.

Why it matters

Potential benefit: If successful, this study could provide critical insights into the safety and long-term health effects of antiretroviral medications on children born to HIV-infected mothers.

How similar studies have performed: While this study addresses a critical gap in understanding ART toxicity, similar studies have not been extensively conducted, making this approach relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Dynamic Cohort:

* HIV-exposed living fetus greater than or equal to 23 weeks gestation or a live infant born after 22 weeks gestation. Infants exposed and unexposed to ART will be enrolled.
* Any infant born of an HIV-infected mother may be enrolled pending determination of the infant's HIV infection status. However, infants found to be HIV-positive will be discontinued from the study and will be referred for care outside this study. HIV infection status will be determined using the Diagnosis of Lack of Infection in HIV-Exposed Children.
* ART exposure data by trimester of pregnancy must be available if ART exposed.
* Entry prior to birth through \< 72 hours of age.
* Willingness of parent/legal guardian to provide written permission for child to participate in study.
* Willingness of biological mother to enroll at initial enrollment of her child.

Exclusion Criteria:

Dynamic Cohort:

None

Where this trial is running

Birmingham, Alabama and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Antiretroviral Toxicity, Conditions and diagnoses potentially related to perinatal exposure to antiretroviral medications

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.