NCT01310023Completed
Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women
Source: ClinicalTrials.gov · Last updated 27 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 5169 (actual)
- First submitted
- 4 Mar 2011
- Start date
- Mar 2007
- Primary completion date
- 31 May 2025
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Diseases
- HIV
- NCT number
- NCT01310023
What you commit to
- Study type: Observational
- Participants enrolled: 5169
- From Mar 2007 to the primary completion date, 31 May 2025
- 22 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Dynamic Cohort:
- None
Who the study is looking for
- 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.
Sex: All · Accepts healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Puerto Rico Medical Center Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| San Juan Research Hospital Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| University of Colorado Denver Health Sciences Center Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| University of Maryland Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| University of Alabama Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| SUNY Downstate Medical Center Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| University of Illinois Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Ann and Robert H. Lurie Children's Hospital Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Children's Diagnostic & Treatment Center Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Florida Health Science Center Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| University of California San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| University of Southern California Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Rutgers New Jersey Medical School Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Tulane University Health Sciences Center Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| New York University School of Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| SUNY-Stony Brook Coordinator of this site? Confirm its status | Stony Brook | United States | Unknown status |
| Jacobi Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Bronx-Lebanon Hospital Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.