Evidence map›Paper›PMID 23340561›Full record

ArticleThe Pediatric infectious disease journal2013

Safety of perinatal exposure to antiretroviral medications: developmental outcomes in infants.

Patricia A Sirois, Yanling Huo, Paige L Williams, Kathleen Malee, Patricia A Garvie, Betsy Kammerer, Kenneth Rich, Russell B Van Dyke, Molly L Nozyce, Pediatric HIVAIDS Cohort Study

Registry-linked trialOpen access · greenAbstract readMulticenter Study
In one paragraph

Article in The Pediatric infectious disease journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01310023 (Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women), which is not on this map. Cited by 43 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01310023 completednot on this map

Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women

TypeobservationalSponsorHarvard School of Public Health (HSPH)Ran2007 to 2025Enrolled5,169ConditionsAntiretroviral Toxicity
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 1 synthesis or guideline pooled it, 66 citations in OpenAlex.

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  16. Evaluating Neurodevelopmental Consequences of Perinatal Exposure to Antiretroviral Drugs: Current Challenges and New Approaches.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2021
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 2 countries.

Patricia A SiroisDepartment of Pediatrics, Tulane University School of Medicine, New Orleans, LA 70112, USA. psirois@tulane.edu
Yanling Huo
Paige L Williams
Kathleen Malee
Patricia A Garvie
Betsy Kammerer
Kenneth Rich
Russell B Van Dyke
Molly L Nozyce
Pediatric HIVAIDS Cohort Study
Tulane University · USHarvard University · USBoston Children's Museum · USFIT Consulting (Italy) · ITNorthwestern University · USUniversity of Illinois Chicago · US

Funding

PHACS - Data and Operations CenterU01HD052102 · NICHD · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI WILLIAMS, PAIGE L · 2005 to 2019
$242.7M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
Pediatric HIV/AIDS Cohort Study (PHACS): Understanding Maternal HIV Disease through Pregnancy and the Postpartum Period and its Role in Child Health OutcomesU01HD052104 · NICHD · TULANE UNIVERSITY OF LOUISIANA · PI VAN DYKE, RUSSELL B. · 2005 to 2019
$15.7M
NCATS NIH HHS UL1 TR001082NICHD NIH HHS HD052102NICHD NIH HHS HD052104NICHD NIH HHS U01 HD052102NICHD NIH HHS U01 HD052104
6 · The paper itself

Abstract

backgroundThis study evaluated effects of perinatal exposure to antiretroviral (ARV) medications on neurodevelopment of HIV-exposed, uninfected infants.

methodsHIV-exposed, uninfected infants (age 9-15 months) enrolled in Surveillance Monitoring for Antiretroviral Therapy Toxicities, a multisite prospective surveillance study, completed the Bayley Scales of Infant and Toddler Development-Third Edition (Bayley-III), assessing cognition, language, motor skills, social-emotional development and adaptive behavior. Linear regression models were used to evaluate associations between Bayley-III outcomes in infants with and without perinatal and neonatal ARV exposure, by regimen (combination ARV [cARV] versus non-cARV), type of regimen (defined by drug class) and individual ARVs (for infants with cARV exposure), adjusting for maternal and infant health and demographic covariates.

resultsAs of May 2010, 374 infants had valid Bayley-III evaluations. Median age at testing was 12.7 months; 49% male, 79% black and 16% Hispanic. Seventy-nine percent were exposed to regimens containing protease inhibitors (9% of protease inhibitor-containing regimens also included non-nucleoside reverse transcriptase inhibitors), 5% to regimens containing non-nucleoside reverse transcriptase inhibitors (without protease inhibitor) and 14% to regimens containing only nucleoside reverse transcriptase inhibitors. Overall, 83% were exposed to cARV. No Bayley-III outcome was significantly associated with overall exposure to cARV, ARV regimen or neonatal prophylaxis. For individual ARVs, following sensitivity analyses, the adjusted group mean on the Language domain was within age expectations but significantly lower for infants with perinatal exposure to atazanavir (P = 0.01).

conclusionsThese results support the safety of perinatal ARV use. Continued monitoring for adverse neurodevelopmental outcomes in older children is warranted, and the safety of atazanavir merits further study.

Indexed as

Anti-Retroviral AgentsChild DevelopmentFemaleHIV InfectionsHumansInfantLongitudinal StudiesMaleNervous SystemPerinatal CarePregnancyPregnancy ComplicationsProspective StudiesAnti-Retroviral Agents

Identifiers

PMID23340561
PMCPMC3723344
OpenAlexW2040712012

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.