Clinical trialNCT01310023CompletedObservational

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

SponsorHarvard School of Public Health (HSPH)Enrollment5,169Antiretroviral Toxicity

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Ellen Chadwick, M.D.
Ann & Robert H Lurie Children's Hospital of Chicago
Principal Investigator
clinicaltrials.gov ↗
Paige L Williams
Harvard School of Public Health (HSPH)
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

22 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Puerto Rico

University of Puerto Rico Medical Center
San Juan, PR, Puerto Rico
San Juan Research Hospital
San Juan, Puerto Rico

United States

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
Ann and Robert H. Lurie Children'S Hospital
Chicago, Illinois, United States
University of Illinois, Chicago
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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Mar 2007
Primary completion: 31 May 2025
Completion: 31 May 2025
Last update posted: 27 Jun 2025
Registered enrollment: 5,169
Registry id: NCT01310023

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.