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

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.

Conditions

Antiretroviral Toxicity

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Antiretroviral Toxicity
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama, Birmingham, Alabama, United States, 35294

La Jolla

University of California San Diego, La Jolla, California, United States, 92093

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Aurora

University of Colorado Denver Health Sciences Center, Aurora, Colorado, United States, 80045

Fort Lauderdale

Children's Diagnostic & Treatment Center, Fort Lauderdale, Florida, United States, 33316

Jacksonville

University of Florida Health Science Center, Jacksonville, Florida, United States, 32209

Miami

University of Miami, Miami, Florida, United States, 33136

Chicago

University of Illinois, Chicago, Chicago, Illinois, United States, 60612

Chicago

Ann and Robert H. Lurie Children's Hospital, Chicago, Illinois, United States, 60614

New Orleans

Tulane University Health Sciences Center, New Orleans, Louisiana, United States, 70112

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

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

2025-07