Evidence map›Paper›PMID 25961889›Full record

ArticleThe Pediatric infectious disease journal2015

Meconium Tenofovir Concentrations and Growth and Bone Outcomes in Prenatally Tenofovir Exposed HIV-Uninfected Children.

Sarah K Himes, Julia W Wu, Denise L Jacobson, Katherine Tassiopoulos, Rohan Hazra, Deborah Kacanek, Russell B Van Dyke, Kenneth C Rich, George K Siberry, Marilyn A Huestis and 1 more

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in The Pediatric infectious disease journal, 2015. 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 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 11% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Frontiers in endocrinology · 2026
    Article
  6. Article
  7. Article
  8. Observational
  9. Article
  10. In Utero Tenofovir Exposure Is not Associated With Fetal Long Bone Growth.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016
    Article
  11. Review
  12. Bone health in HIV-infected children and adolescents.Current opinion in HIV and AIDS · 2016
    Review
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

11 authors at 5 institutions in 1 country.

Sarah K HimesFrom the *Chemistry and Drug Metabolism Section, Intramural Research Program, National Institute on Drug Abuse, National Institutes of Health, Baltimore, Maryland; †Department of Epidemiology, ‡Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts; §Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland; ¶Department of Pediatrics, Tulane University School of Medicine, New Orleans, Louisiana; and ‖Pediatrics Department, University of Illinois at Chicago, Chicago, Illinois.
Julia W Wu
Denise L Jacobson
Katherine Tassiopoulos
Rohan Hazra
Deborah Kacanek
Russell B Van Dyke
Kenneth C Rich
George K Siberry
Marilyn A Huestis
Pediatric HIVAIDS Cohort Study (PHACS)
Cancer Research And Biostatistics · USNational Institutes of Health · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USNational Institute on Drug Abuse · USTulane University · 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
Monitoring In Utero Drug ExposureZIADA000433 · NIDA · NATIONAL INSTITUTE ON DRUG ABUSE · PI SCHEIDWEILER, KARL · 2009 to 2016
$2.9M
NCATS NIH HHS UL1 TR001082NICHD NIH HHS 3 U01 HD052102-05S1NICHD NIH HHS 3 U01 HD052102-06S3NICHD NIH HHS 3U01HD052104-06S1NICHD NIH HHS HD052102NICHD NIH HHS HD052104NICHD NIH HHS U01 HD052102NICHD NIH HHS U01 HD052104
6 · The paper itself

Abstract

backgroundMaternal tenofovir disoproxil fumarate (TDF) treatment among HIV-infected pregnant women results in fetal tenofovir (TFV) exposure. Fetal TFV toxicity was demonstrated in animals, but most clinical investigations have not observed toxicity in humans.

methodsWe evaluated HIV-exposed, uninfected infants in the Surveillance Monitoring for Antiretroviral Therapy Toxicities cohort of the Pediatric HIV/AIDS Cohort Study whose mothers were prescribed TDF for ≥ 8 third trimester weeks. Infant dual-energy X-ray absorptiometry scans were obtained at 0-4 weeks to measure whole body bone mineral content. Meconium TFV concentrations were quantified by liquid chromatography-tandem mass spectrometry.

resultsFifty-eight TFV-exposed infants had meconium TFV quantified. Detectable concentrations were 11-48,100 ng/g; 3 infants had undetectable concentrations. Maternal TDF prescription duration ranged from 8 to 41 gestational weeks; infant gestational ages were 36-41 weeks. Meconium TFV concentrations were not correlated with TFV exposure duration or timing and did not vary by concomitant prescription of protease inhibitors. Increased meconium TFV concentrations were associated with greater gestational ages (ρ = 0.29, P = 0.03) and lower maternal plasma HIV RNA before delivery (ρ = -0.29, P = 0.04). Meconium TFV concentrations were not associated with infant weight, length (n = 58) or bone mineral content (n = 49).

conclusionsFor the first time, we explored associations between meconium TFV concentrations and infant growth and bone measurements; we did not observe a meconium concentration-dependent relationship for these infant outcomes. These findings support other clinical research failing to show dose-response relationships for growth and bone outcomes among intrauterine TFV-exposed infants. High meconium TFV concentrations correlated with low maternal viral load, suggesting maternal TDF adherence significantly contributes to meconium TFV concentrations.

Indexed as

AdolescentAdultAnti-HIV AgentsBone DensityFemaleGestational AgeHIV InfectionsHumansInfant, NewbornInfectious Disease Transmission, VerticalMaleMaternal ExposureMeconiumMiddle AgedPregnancyPregnancy Complications, InfectiousAnti-HIV AgentsTenofovir

Identifiers

PMID25961889
PMCPMC4573821
OpenAlexW1590146806

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.