Cardiovascular outcomes of pediatric seroreverters perinatally exposed to HAART: design of a longitudinal clinical study.
Seroreverters (uninfected children of HIV-infected mothers) have exhibited left ventricular (LV) dysfunction. Mitochondrial toxicity associated with in utero or postnatal exposure to highly active antiretroviral therapy (HAART) is a possible mechanism. Adult and animal models have demonstrated associations between LV abnormalities, cardiomyopathy, and components of HAART. Yet, outcomes in children are poorly understood. In this study, we explore HAART-associated LV abnormalities in seroreverters exposed to HAART (n = 144) or never exposed (n = 252). Subjects are drawn from the Women and Infants Transmission Study and the Pediatric Pulmonary and Cardiovascular Complications of HIV Study, respectively. Data include (1) echocardiographic studies of LV structure and function and (2) serologic cardiac biomarkers (cardiac troponin, probrain natriuretic peptide, high-sensitivity C reactive protein), both collected during the first month of life, and again at 6, 12, 24, 36, and 48 months postnatally. Planned analyses include several regression models. At this time, we have access to data for all 252 unexposed children, and 53 exposed subjects are enrolled. The cohorts are similar in terms of gender and race and the recruited subjects are representative of all eligible subjects in terms of exposure to HAART. Recruitment will continue into 2006.
Lavigne
Jill E
JE
University of Rochester, Rochester, NY, USA.
Shearer
William T
WT
Thompson
Bruce
B
Orav
E John
EJ
Starc
Thomas J
TJ
Colan
Steven D
SD
Pignatelli
Ricardo
R
O'Brien
Sharon E
SE
Bezold
Louis
L
LaRusa
Phillip
P
Easley
Kirk A
KA
Cheng
Irene
I
Duffy
Sarah A
SA
Lipshultz
Steven E
SE
D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects; D015415:Biomarkers / Q000097:blood; D002675:Child, Preschool; D015331:Cohort Studies; D004562:Electrocardiography; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control* / Q000635:transmission; D018023:HIV Seronegativity; D006331:Heart Diseases / Q000139:chemically induced* / Q000196:embryology / Q000503:physiopathology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D008297:Male; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D013997:Time Factors; D018487:Ventricular Dysfunction, Left / Q000139:chemically induced / Q000503:physiopathology
D019380:Anti-HIV Agents; D015415:Biomarkers