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

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Conditions

Antiretroviral ToxicityConditions and diagnoses potentially related to perinatal exposure to antiretroviral medications

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2007-03
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT01310023

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * ART exposure data by trimester of pregnancy must be available if ART exposed.
  4. * Entry prior to birth through \< 72 hours of age.
  5. * Willingness of parent/legal guardian to provide written permission for child to participate in study.
  6. * Willingness of biological mother to enroll at initial enrollment of her child.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

University of Alabama
Birmingham, Alabama, 35294
United States
University of California San Diego
La Jolla, California, 92093
United States
University of Southern California
Los Angeles, California, 90033
United States
University of Colorado Denver Health Sciences Center
Aurora, Colorado, 80045
United States
Children's Diagnostic & Treatment Center
Fort Lauderdale, Florida, 33316
United States
University of Florida Health Science Center
Jacksonville, Florida, 32209
United States
University of Miami
Miami, Florida, 33136
United States
University of Illinois, Chicago
Chicago, Illinois, 60612
United States
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, 60614
United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
United States
University of Maryland
Baltimore, Maryland, 21201
United States
Rutgers - New Jersey Medical School
Newark, New Jersey, 07101-1709
United States
Bronx Lebanon Hospital Center
Bronx, New York, 10457
United States
Jacobi Medical Center
Bronx, New York, 10461
United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203-2098
United States
New York University School of Medicine
New York, New York, 10016
United States
SUNY Stony Brook
Stony Brook, New York, 11794
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4318
United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105-2764
United States
Baylor College of Medicine
Houston, Texas, 77030-3498
United States

Collaborators and Investigators

Sponsor: Harvard School of Public Health (HSPH)

  • Paige L Williams, PRINCIPAL_INVESTIGATOR, Harvard School of Public Health (HSPH)
  • Ellen Chadwick, M.D., PRINCIPAL_INVESTIGATOR, Ann & Robert H Lurie Children's Hospital of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2007-03
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2007-03
Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

  • Conditions and diagnoses potentially related to perinatal exposure to antiretroviral medications

Additional Relevant MeSH Terms

  • Antiretroviral Toxicity