The Pediatric HIV AIDS Cohort Study addresses two critical research questions: (1) the consequences of fetal and infant exposure to antiretroviral therapy (ART) when used to prevent mother-to-child transmission of HIV-1, and (2) the clinical course of perinatal HIV infection among children as they proceed through adolescence towards adulthood. These questions are being addressed through two separate protocols being conducted at multiple sites in the US and Puerto Rico.
The specific aim of the SMARTT Study is, among HIV-exposed infants, to define the short and long-term safety of ART exposure. To accomplish this, HIV-uninfected children born to infected mothers are evaluated prospectively for growth, neurodevelopment, cardiac and other end-organ function. Children with abnormalities will be further evaluated to determine if they result from ART toxicity, with particular emphasis on mitochondrial dysfunction.
The specific aims of AMP are, among a cohort of pre-adolescents and adolescents with perinatal HIV (1) to define the impact of HIV infection and ART on: growth and development;sexual maturation;pubertal development;development of risk factors for cardiovascular disease;cognitive, academic, vocational, sexual, and social functioning;mental health;and risk taking behavior including substance use. (2) to identify infectious and non-infectious complication of HIV disease and ART therapy, including end organ disease (neurologic, renal, pulmonary, bone) and nutritional and metabolic abnormalities. (3) to study genetic, epigenetic, virologic (including antiretroviral resistance), and immunologic factors which impact the course of HIV infection, its complications and response to treatment. In both protocols, subjects and their primary caregivers are prospectively evaluated according to a standardized protocol. Both utilize a strategy of triggered evaluations, with specific abnormal findings leading to additional evaluations to characterize the abnormality. Repository specimens are collected for further biochemical and genetic testing.

Public Health Relevance

Defining the safety of preventive ART during pregnancy - including the safety of individual drugs - is necessary to define the safest strategy to prevent mother-to-transmission of HIV. Perinatal HIV has become a chronic condition, and an understanding of the long-term outcomes of the infection and its treatment is necessary to provide care for these children.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HD052104-10
Application #
8695417
Study Section
Special Emphasis Panel (ZHD1-DSR-A (06))
Program Officer
Russo, Denise
Project Start
2005-09-30
Project End
2015-07-31
Budget Start
2014-08-01
Budget End
2015-07-31
Support Year
10
Fiscal Year
2014
Total Cost
$980,687
Indirect Cost
$207,462
Name
Tulane University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
053785812
City
New Orleans
State
LA
Country
United States
Zip Code
70118
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Uprety, Priyanka; Patel, Kunjal; Karalius, Brad et al. (2017) Human Immunodeficiency Virus Type 1 DNA Decay Dynamics With Early, Long-term Virologic Control of Perinatal Infection. Clin Infect Dis 64:1471-1478
Jacobson, Denise L; Patel, Kunjal; Williams, Paige L et al. (2017) Growth at 2 Years of Age in HIV-exposed Uninfected Children in the United States by Trimester of Maternal Antiretroviral Initiation. Pediatr Infect Dis J 36:189-197
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Bellavia, Andrea; Williams, Paige L; DiMeglio, Linda A et al. (2017) Delay in sexual maturation in perinatally HIV-infected youths is mediated by poor growth. AIDS 31:1333-1341
Neilan, Anne M; Karalius, Brad; Patel, Kunjal et al. (2017) Association of Risk of Viremia, Immunosuppression, Serious Clinical Events, and Mortality With Increasing Age in Perinatally Human Immunodeficiency Virus-Infected Youth. JAMA Pediatr 171:450-460
Rice, Mabel L; Russell, Jonathan S; Frederick, Toni et al. (2017) Risk for Speech and Language Impairments in Pre-school Aged HIV-Exposed Uninfected Children with in utero Combination Antiretroviral Exposure. Pediatr Infect Dis J :
Lewis-de Los Angeles, C Paula; Williams, Paige L; Huo, Yanling et al. (2017) Lower total and regional grey matter brain volumes in youth with perinatally-acquired HIV infection: Associations with HIV disease severity, substance use, and cognition. Brain Behav Immun 62:100-109

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