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

Completed

Conditions studied: Antiretroviral Toxicity

In brief

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.

Key facts

Study ID

NCT01310023

Run by

Harvard School of Public Health (HSPH)

People needed

5169

Starts

2007-03-01

Expected to finish

2025-05-31

Last updated by the study team

2025-06-27

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Dynamic Cohort:
• None

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• University of California San Diego — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• University of Colorado Denver Health Sciences Center — Aurora, Colorado, United States
• Children's Diagnostic & Treatment Center — Fort Lauderdale, Florida, United States
• University of Florida Health Science Center — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• University of Illinois, Chicago — Chicago, Illinois, United States
• Ann and Robert H. Lurie Children's Hospital — Chicago, Illinois, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Rutgers - New Jersey Medical School — Newark, New Jersey, United States
• SUNY Downstate Medical Center — Brooklyn, New York, United States
• New York University School of Medicine — New York, New York, United States
• SUNY Stony Brook — Stony Brook, New York, United States
• Bronx Lebanon Hospital Center — The Bronx, New York, United States
• Jacobi Medical Center — The Bronx, New York, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Puerto Rico Medical Center — San Juan, PR, Puerto Rico
• San Juan Research Hospital — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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