Evidence map›Paper›PMID 22585772›Full record

Trial reportPediatrics2012

Infant outcomes after maternal antiretroviral exposure in resource-limited settings.

Karin Nielsen-Saines, Lauren Komarow, Susan Cu-Uvin, Gonzague Jourdain, Karin L Klingman, David E Shapiro, Lynne Mofenson, Laura Moran, Thomas B Campbell, Jane Hitti and 3 more

Abstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Pediatrics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Zika Virus: An Emerging Global Health Threat.Frontiers in cellular and infection microbiology · 2017
    Review
  4. Article
  5. Article
  6. DisclosingJournal of the International AIDS Society · 2016
    Article
  7. Review
  8. Article
  9. Article
  10. 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

13 authors.

Karin Nielsen-SainesDepartment of Pediatrics, Division of Infectious Diseases, David Geffen UCLA School of Medicine, MDCC 22-442, 10833 LeConte Ave, Los Angeles, CA 90095, USA. knielsen@mednet.ucla.edu
Lauren Komarow
Susan Cu-Uvin
Gonzague Jourdain
Karin L Klingman
David E Shapiro
Lynne Mofenson
Laura Moran
Thomas B Campbell
Jane Hitti
Susan Fiscus
Judith Currier
ACTG 5190/PACTG 1054 Study Team

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
HIV PREVENTION TRIALS NETWORK LEADERSHIP GROUPU01AI046749 · NIAID · FAMILY HEALTH INTERNATIONAL · PI CATES, WILLARD · 1999 to 2005
$73.5M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
UZ-UCSF Clinical Trials UnitU01AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CHIRENJE, ZVAVAHERA MIKE · 2007 to 2011
$49.3M
The Malawi Clinical Trials UnitU01AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI TAHA, TAHA E · 2007 to 2011
$46.7M
Statistical/Data Management Center-Pediatric AIDS CTGU01AI041110 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI FENTON, TERRENCE · 1997 to 2006
$38.6M
NIAID NIH HHS 1 U01 AI068616NIAID NIH HHS 1 U01 AI069463-01NIAID NIH HHS 1 U01 AI069518NIAID NIH HHS 5 U01 AI069399-05NIAID NIH HHS 5 U01 AI069436-02NIAID NIH HHS 5 U01 AI069450NIAID NIH HHS 5 U01 AI41110NIAID NIH HHS AI068632NIAID NIH HHS AI68634NIAID NIH HHS P30 AI050410NIAID NIH HHS U01 AI041110NIAID NIH HHS U01 AI046749NIAID NIH HHS U01 AI047986NIAID NIH HHS U01 AI068616NIAID NIH HHS U01 AI068632NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069399NIAID NIH HHS U01 AI069401NIAID NIH HHS U01 AI069429NIAID NIH HHS U01 AI069432NIAID NIH HHS U01 AI069436NIAID NIH HHS U01 AI069450NIAID NIH HHS U01 AI069463NIAID NIH HHS U01 AI069512NIAID NIH HHS U01AI069512NIAID NIH HHS U01 AI069518NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI106701NICHD NIH HHS HHSN267200800001CNICHD NIH HHS N01-HD-3-3345NIDDK NIH HHS HHSN267200800001GNIDDK NIH HHS N01-DK-9-01
6 · The paper itself

Abstract

BACKGROUND AND

objectiveThe impact of maternal antiretrovirals (ARVs) during pregnancy, labor, and postpartum on infant outcomes is unclear.

methodsInfants born to HIV-infected mothers in ARV studies were followed for 18 months.

resultsBetween June 2006 and December 2008, 236 infants enrolled from Africa (n = 36), India (n = 47), Thailand (n = 152), and Brazil (n = 1). Exposure to ARVs in pregnancy included ≥ 3 ARVs (10%), zidovudine/intrapartum ARV (81%), and intrapartum ARV (9%). There were 4 infant infections (1 in utero, 3 late postpartum) and 4 deaths with 1.8% mortality (95% confidence interval [CI], 0.1%-3.5%) and 96.4% HIV-1-free survival (95% CI, 94.0%-98.9%). Birth weight was ≥ 2.5 kg in 86%. In the first 6 months, Indian infants (nonbreastfed) had lowest median weights and lengths and smallest increases in growth. After 6 months, African infants had the lowest median weight and weight-for-age z scores. Infants exposed to highest maternal viral load had the lowest height and height-for-age z scores. Serious adverse events occurred in 38% of infants, did not differ by country, and correlated with less maternal ARV exposure. Clinical diagnoses were seen in 84% of Thai, 31% of African, and 9% of Indian infants. Congenital defects/inborn errors of metabolism were seen in 18 (7.6%) infants, of which 17 were Thai (11%: 95% CI, 6.7%-17.0%); none had first trimester ARV exposure.

conclusionsInfant follow-up in large international cohorts is feasible and provides important safety and HIV transmission data following maternal ARV exposure. Increased surveillance increases identification of congenital/inborn errors.

Indexed as

Health ResourcesHIV-1Infectious Disease Transmission, VerticalAnti-HIV AgentsCohort StudiesDeveloping CountriesFemaleFollow-Up StudiesHIV InfectionsHumansInfantInternationalityPregnancyPregnancy Complications, InfectiousProspective StudiesTreatment OutcomeAnti-HIV Agents

Identifiers

PMID22585772
PMCPMC3362906

What OpenQuestion holds

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Registered trials

None linked

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.