Document Detail

Birth defects among a cohort of infants born to HIV-infected women on antiretroviral medication.
MedLine Citation:
PMID:  21142844     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To determine rate of and risk factors for birth defects in infants born to HIV-infected women receiving nucleoside and protease inhibitor antiretroviral (ARV) therapy.
METHODS: Birth defects were evaluated among infants on the Pediatric AIDS Clinical Trials Group 316 trial that studied addition of peripartum nevirapine to established ARV regimen for prevention of mother-to-child transmission. Maternal therapy was categorized by trimester of earliest exposure. Birth defects were coded using conventions of the Antiretroviral Pregnancy Registry.
RESULTS: Birth defects were detected in 60/1414 (4.2%; 95% CI 3.3-5.4%) infants including 30/636 (4.7%; 95% CI 3.2-6.7%) with first trimester ARV exposure and 30/778 (3.9%; 95% CI 2.6-5.5%) with exposure only after the first trimester (P=0.51). Rates of classes of defects were similar between first trimester compared to later exposure groups except heart defects which occurred in 16 (2.5%; 95% CI 1.4-4.1%) with first trimester ARV exposure and in six (0.8%; 95% CI 0.3-1.7%) infants with later exposure (P=0.02). Exposure to ARV was not associated with specific types of heart defects. Two cases of cardiomyopathy were noted.
CONCLUSION: ARV use in early pregnancy was not associated with an increased risk of birth defects overall. The possible association of ARV exposure with heart defects requires further surveillance.
D Heather Watts; Sharon Huang; Mary Culnane; Kathleen A Kaiser; Angela Scheuerle; Lynne Mofenson; Kenneth Stanley; Marie-Louise Newell; Laurent Mandelbrot; Jean-Francois Delfraissy; Coleen K Cunningham
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2010-12-13
Journal Detail:
Title:  Journal of perinatal medicine     Volume:  39     ISSN:  1619-3997     ISO Abbreviation:  J Perinat Med     Publication Date:  2011 Mar 
Date Detail:
Created Date:  2011-03-10     Completed Date:  2011-07-08     Revised Date:  2013-07-03    
Medline Journal Info:
Nlm Unique ID:  0361031     Medline TA:  J Perinat Med     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  163-70     Citation Subset:  IM    
Eunice Kennedy Shriver National Institute for Child Health and Human Development, Bethesda, MD, USA.
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MeSH Terms
Anti-HIV Agents / adverse effects*
Cohort Studies
Congenital Abnormalities / epidemiology,  etiology*
Double-Blind Method
HIV Infections / complications*,  drug therapy*,  transmission
Heart Defects, Congenital / epidemiology,  etiology
Infant, Newborn
Infectious Disease Transmission, Vertical / prevention & control
Nevirapine / adverse effects
Pregnancy Complications, Infectious / drug therapy*
Risk Factors
Grant Support
5 U01 AI41110/AI/NIAID NIH HHS; AI068632/AI/NIAID NIH HHS; N01-DK-9-001/HHSN267200800001C/DK/NIDDK NIH HHS; U01 AI068632/AI/NIAID NIH HHS; U01 AI068632-03/AI/NIAID NIH HHS
Reg. No./Substance:
0/Anti-HIV Agents; 129618-40-2/Nevirapine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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