Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
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.
Phase
N/A
Funding Agency/Sponsor
Other
Disease
HIV-related
Enrollment Eligibility
Inclusion Criteria:
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.
Exclusion Criteria:
Dynamic Cohort:
None
Accepts Healthy Volunteers
Call +1 (305) 2434447