CompletedNot Applicable

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

United States, Puerto Rico5,169 participantsStarted 2007-03

Plain-language summary

SMARTT will estimate the incidence of conditions and diagnoses potentially related to in utero exposure to antiretroviral therapy and/or exposure in the first two months of life among children born of HIV-infected mothers.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neurologic abnormalities

Timeframe: Annually birth through age 5; semiannual thereafter, assessments vary based on age of child.

Neurodevelopmental abnormalities

Timeframe: 1, 3, 5, 9, and 13 years of age, assessments vary based on age of child.

Abnormal growth and metabolic function

Timeframe: Annually birth through age 5; semiannual thereafter, assessments vary based on age of child.

Cardiac abnormalities

Timeframe: Ages 3-5.

Hearing dysfunction

Timeframe: At age 5 and for children of all ages meeting a hearing/language trigger.

Language dysfunction

Timeframe: 1, 2, 3, 5, and 9 years of age, assessments vary based on age.

Drug Use and Sexual Activity

Timeframe: 11, 13, 15, and 17 years of age.

Trial details

NCT IDNCT01310023

SponsorHarvard School of Public Health (HSPH)

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-05-31

View on ClinicalTrials.gov More Antiretroviral Toxicity trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Neurologic abnormalities

Timeframe: Annually birth through age 5; semiannual thereafter, assessments vary based on age of child.

Neurodevelopmental abnormalities

Timeframe: 1, 3, 5, 9, and 13 years of age, assessments vary based on age of child.

Abnormal growth and metabolic function

Timeframe: Annually birth through age 5; semiannual thereafter, assessments vary based on age of child.

Cardiac abnormalities

Timeframe: Ages 3-5.

Hearing dysfunction

Timeframe: At age 5 and for children of all ages meeting a hearing/language trigger.

Language dysfunction

Timeframe: 1, 2, 3, 5, and 9 years of age, assessments vary based on age.

Drug Use and Sexual Activity

Timeframe: 11, 13, 15, and 17 years of age.