Evidence map›Paper›PMID 26867136›Full record

ArticleAIDS (London, England)2016

Atazanavir exposure in utero and neurodevelopment in infants: a comparative safety study.

Ellen C Caniglia, Kunjal Patel, Yanling Huo, Paige L Williams, Suad Kapetanovic, Kenneth C Rich, Patricia A Sirois, Denise L Jacobson, Sonia Hernandez-Diaz, Miguel A Hernán and 2 more

2 registry-linked trialsOpen access · greenAbstract readComparative Study
In one paragraph

Article in AIDS (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
4.0field-weighted citation impact, top 6% 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
NCT01418014 completednot on this map

Adolescent Master Protocol

TypeobservationalSponsorHarvard School of Public Health (HSPH)Ran2007 to 2021Enrolled678ConditionsHIV/AIDS
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.

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  10. Neurodevelopment of children who are HIV-exposed and uninfected in Kenya.Journal of the International AIDS Society · 2023
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 2 countries.

Ellen C CanigliaaHarvard T.H. Chan School of Public Health, Boston, Massachusetts bDepartment of Psychiatry and Behavioral Sciences, University of Southern California Keck School of Medicine, Los Angeles, California cNational Institutes of Health, National Institute of Mental Health, Bethesda, Maryland dUniversity of Illinois at Chicago College of Medicine, Chicago, Illinois eTulane University School of Medicine, New Orleans, Louisiana fHarvard-MIT Division of Health Sciences and Technology, Boston, Massachusetts, USA.
Kunjal Patel
Yanling Huo
Paige L Williams
Suad Kapetanovic
Kenneth C Rich
Patricia A Sirois
Denise L Jacobson
Sonia Hernandez-Diaz
Miguel A Hernán
George R Seage
Pediatric HIVAIDS Cohort Study
Apple (Israel) · ILHarvard University · US

Funding

PHACS - Data and Operations CenterU01HD052102 · NICHD · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI WILLIAMS, PAIGE L · 2005 to 2019
$242.7M
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
PROGRAM FOR AIDS CLINICAL RESEARCH TRAINING (PACRT)T32AI007433 · NIAID · MASSACHUSETTS GENERAL HOSPITAL · PI MARK J SIEDNER · 1992 to 2026
$11.4M
NIAID NIH HHS T32 AI007433NICHD NIH HHS U01 HD052102NICHD NIH HHS U01 HD052104
6 · The paper itself

Abstract

objectiveTo evaluate the safety of in-utero exposure to atazanavir and neurodevelopment in perinatally HIV-exposed but uninfected (PHEU) infants.

designProspective cohort study of mother-PHEU infant pairs in the Surveillance Monitoring for ART Toxicities protocol of the Pediatric HIV/AIDS Cohort Study.

methodsPregnant women living with HIV who initiated an antiretroviral regimen during pregnancy were followed from the date of antiretroviral initiation. Women were classified according to whether the antiretroviral regimen contained atazanavir and the trimester of antiretroviral initiation. Neurodevelopment at 9-15 months was evaluated using the Bayley Scales of Infant and Toddler Development-Third Edition (Bayley-III). We estimated mean differences for the five Bayley-III domains for atazanavir-containing regimens versus all other regimens. Models included baseline covariates and adjustment for failure to complete the Bayley-III using inverse probability weighting.

resultsPHEU infants were exposed in utero to atazanavir-containing (n = 167) and nonatazanavir-containing (n = 750) antiretroviral regimens. The adjusted mean differences (95% confidence interval) in Bayley-III domain scores for initiating an atazanavir-containing regimen in the first trimester were: cognitive, -1.5 (-6.2, 3.2); language, -3.3 (-7.6, 1.0); motor, -2.9 (-7.7, 1.9); social-emotional, 0.1 (-6.2, 6.4); and adaptive behavior, -0.1 (-4.3, 4.0). The mean differences for the second or third trimester were: cognitive, 0.4 (-3.2, 4.0); language, -3.4 (-6.2, -0.5); motor, 0.3 (-2.9, 3.4); social-emotional, -5.9 (-9.4, -2.3); and adaptive behavior, -2.5 (-5.9, 0.8).

conclusionIn-utero exposure to atazanavir-containing regimens compared with non-atazanavir-containing regimens may adversely affect language and social-emotional development in PHEU infants during the first year of life, but the absolute difference is small.

Indexed as

Prenatal Exposure Delayed EffectsAdultAtazanavir SulfateFemaleFetal DevelopmentFollow-Up StudiesHIV InfectionsHIV Protease InhibitorsHumansInfantInfant, NewbornMaleNervous SystemPregnancyPregnancy Complications, InfectiousProspective StudiesAtazanavir SulfateHIV Protease Inhibitors

Identifiers

PMID26867136
PMCPMC4851579
OpenAlexW2315261964

What OpenQuestion holds

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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.