| Birth defects among a cohort of infants born to HIV-infected women on antiretroviral medication. | |
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MedLine Citation:
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PMID: 21142844 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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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:
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Title: Journal of perinatal medicine Volume: 39 ISSN: 1619-3997 ISO Abbreviation: J Perinat Med Publication Date: 2011 Mar |
Date Detail:
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Created Date: 2011-03-10 Completed Date: 2011-07-08 Revised Date: 2011-07-27 |
Medline Journal Info:
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Nlm Unique ID: 0361031 Medline TA: J Perinat Med Country: Germany |
Other Details:
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Languages: eng Pagination: 163-70 Citation Subset: IM |
Affiliation:
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Eunice Kennedy Shriver National Institute for Child Health and Human Development, Bethesda, MD, USA. hw59i@nih.gov |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Anti-HIV Agents / adverse effects* Cohort Studies Congenital Abnormalities / epidemiology, etiology* Double-Blind Method Female HIV Infections / complications*, drug therapy*, transmission Heart Defects, Congenital / epidemiology, etiology Humans Infant, Newborn Infectious Disease Transmission, Vertical / prevention & control Nevirapine / adverse effects Pregnancy Pregnancy Complications, Infectious / drug therapy* Risk Factors |
| Grant Support | |
ID/Acronym/Agency:
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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 |
| Chemical | |
Reg. No./Substance:
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0/Anti-HIV Agents; 129618-40-2/Nevirapine |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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