Evidence map›Paper›PMID 24504006›Full record

Trial reportPloS one2014

Maternal valacyclovir and infant cytomegalovirus acquisition: a randomized controlled trial among HIV-infected women.

Alison C Roxby, Claire Atkinson, Kristjana Asbjörnsdóttir, Carey Farquhar, James N Kiarie, Alison L Drake, Anna Wald, Michael Boeckh, Barbra Richardson, Vincent Emery and 2 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00530777 (HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding), which is not on this map. Cited by 26 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 3 pooled it
4.1field-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.

NCT00530777 phase2completednot on this map

HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding

TypeinterventionalSponsorUniversity of WashingtonRan2008 to 2010Enrolled148ConditionsHIV Infections, Herpes SimplexArmsvalacyclovir, placebo
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 3 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Congenital Cytomegalovirus and HIV Perinatal Transmission.The Pediatric infectious disease journal · 2018
    Trial
  5. Trial
  6. Article
  7. Article
  8. Review
  9. Review
  10. Article
  11. The impact of maternal HIV and malaria infection on the prevalence of congenital cytomegalovirus infection in Western Kenya.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2019
    Article
  12. Article
  13. Review
  14. Article
  15. Cytomegalovirus infection in pregnancy.Birth defects research · 2017
    Review
  16. Review
  17. Cytomegalovirus and paediatric HIV infection.Journal of virus eradication · 2016
    Article
  18. Article
  19. Observational
  20. 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

12 authors at 4 institutions in 3 countries.

Alison C RoxbyDepartment of Medicine, University of Washington, Seattle, Washington, United States of America.
Claire AtkinsonCentre for Virology, Department of Infection, School of Biomedical and Life Sciences, University College London, London, United Kingdom.
Kristjana AsbjörnsdóttirDepartment of Epidemiology, University of Washington, Seattle, Washington, United States of America.
Carey FarquharDepartment of Medicine, University of Washington, Seattle, Washington, United States of America ; Department of Epidemiology, University of Washington, Seattle, Washington, United States of America ; Department of Global Health, University of Washington, Seattle, Washington, United States of America.
James N KiarieDepartment of Obstetrics and Gynaecology, University of Nairobi, Nairobi, Kenya.
Alison L DrakeDepartment of Global Health, University of Washington, Seattle, Washington, United States of America.
Anna WaldDepartment of Medicine, University of Washington, Seattle, Washington, United States of America ; Department of Epidemiology, University of Washington, Seattle, Washington, United States of America ; Department of Laboratory Medicine, University of Washington, Seattle, Washington, United States of America ; Division of Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
Michael BoeckhDepartment of Medicine, University of Washington, Seattle, Washington, United States of America ; Division of Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America ; Division of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
Barbra RichardsonDepartment of Global Health, University of Washington, Seattle, Washington, United States of America ; Department of Biostatistics, University of Washington, Seattle, Washington, United States of America ; Division of Vaccine and Infectious Disease, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
Vincent EmeryDepartment of Microbial and Cellular Science, University of Surrey, Guildford, United Kingdom.
Grace John-StewartDepartment of Medicine, University of Washington, Seattle, Washington, United States of America ; Department of Epidemiology, University of Washington, Seattle, Washington, United States of America ; Department of Global Health, University of Washington, Seattle, Washington, United States of America ; Department of Pediatrics, University of Washington, Seattle, Washington, United States of America.
Jennifer A SlykerDepartment of Global Health, University of Washington, Seattle, Washington, United States of America.
University of Washington · USUniversity College London · GBUniversity of Nairobi · KEUniversity of Surrey · GB

Funding

University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI EDWIN ROBERTO ORELLANA · 1988 to 2026
$104.9M
THE PERINATAL COMPLICATIONS OF ASYMPTOMATIC GENITAL HERPES SIMPLEX VIRUSP01AI030731 · NIAID · UNIVERSITY OF WASHINGTON · PI WALD, ANNA · 1991 to 2017
$34.3M
Fogarty International Clinical Research Scholars Support Center @ Vanderbilt-AAMCR24TW007988 · FIC · VANDERBILT UNIVERSITY · PI VERMUND, STEN H. · 2007 to 2011
$27.6M
VENEREAL DISEASET32AI007140 · NIAID · UNIVERSITY OF WASHINGTON · PI Julia Cook Dombrowski · 1985 to 2026
$19.4M
INTERNATIONAL TRAINING GRANT IN EPIDEMIOLOGYD43TW000007 · FIC · UNIVERSITY OF WASHINGTON · PI FARQUHAR, CAREY · 1988 to 2012
$16.3M
Interdisciplinary Tranining in Cancer ResearchT32CA080416 · NCI · UNIVERSITY OF WASHINGTON · PI STODDARD, BARRY L. · 1998 to 2023
$9.7M
THE ROLE OF ANTIBODIES IN MOTHER TO CHILD HIV TRANSMISSIONR01AI076105 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI OVERBAUGH, JULIE M. · 2008 to 2023
$8.8M
Clinical Research in HSV InfectionsK24AI071113 · NIAID · UNIVERSITY OF WASHINGTON · PI WALD, ANNA · 2006 to 2015
$1.7M
Infections in Hematopoietic Cell Transplant RecipientsK24HL093294 · NHLBI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BOECKH, MICHAEL J · 2009 to 2019
$1.5M
Pediatric HIV-1 in Africa: Pathogenesis and ManagementK24HD054314 · NICHD · UNIVERSITY OF WASHINGTON · PI JOHN-STEWART, GRACE C. · 2006 to 2016
$1.2M
Immune activation during pregnancy and contraception in HIV-infected Kenyan womenK23HD071788 · NICHD · UNIVERSITY OF WASHINGTON · PI ROXBY, ALISON CHRISTINA · 2012 to 2016
$648k
HIV-1 and Protective Immunity against Common Childhood PathogensK24AI087399 · NIAID · UNIVERSITY OF WASHINGTON · PI FARQUHAR, CAREY · 2010 to 2014
$647k
FIC NIH HHS D43 TW000007FIC NIH HHS R24 TW007988NCI NIH HHS T32 CA080416NHLBI NIH HHS K24 HL093294NIAID NIH HHS K01 AI087369NIAID NIH HHS K24 AI071113NIAID NIH HHS K24 AI087399NIAID NIH HHS P01 AI030731NIAID NIH HHS P01 AI30731NIAID NIH HHS P30 AI027757NIAID NIH HHS R01 AI076105NIAID NIH HHS T32 AI007140NICHD NIH HHS K23 HD071788NICHD NIH HHS K24 HD 054314NICHD NIH HHS K24 HD054314NICHD NIH HHS R03 HD 057773NICHD NIH HHS R03 HD057773NICHD NIH HHS R03 HD 057773-02S1
6 · The paper itself

Abstract

backgroundStudies in HIV-1-infected infants and HIV-1-exposed, uninfected infants link early cytomegalovirus (CMV) acquisition with growth delay and cognitive impairment. We investigated maternal valacyclovir to delay infant acquisition of CMV.

methodsPregnant women with HIV-1, HSV-2 and CD4 count >250 cells/µl were randomized at 34 weeks gestation to 500 mg twice-daily valacyclovir or placebo for 12 months. Maternal CMV DNA was measured in plasma at 34 weeks gestation, in cervical secretions at 34 and 38 weeks gestation, and in breast milk at 7 postpartum timepoints; infant CMV DNA was measured in dried blood spots at 8 timepoints including birth.

resultsAmong 148 women, 141 infants were compared in intent-to-treat analyses. Maternal and infant characteristics were similar between study arms. Infant CMV acquisition did not differ between study arms, with 46/70 infants (66%) in placebo arm and 47/71 infants (66%) in the valacyclovir arm acquiring CMV; median time to CMV detection did not differ. CMV DNA was detected in 92% of 542 breast milk specimens with no difference in CMV level between study arms. Change in cervical shedding of CMV DNA between baseline and 38 weeks was 0.40-log greater in the placebo arm than the valacyclovir arm (p = 0.05).

conclusionsIn this cohort of HIV-1-seropositive mothers, two-thirds of infants acquired CMV by one year. Maternal valacyclovir had no effect on timing of infant CMV acquisition or breast milk CMV viral loads, although it modestly reduced cervical CMV shedding. Maternal prophylaxis to reduce infant CMV acquisition warrants further evaluation in trials with antiviral agents. TRIALS REGISTRATION: ClinicalTrials.gov NCT00530777.

Indexed as

CytomegalovirusHIV SeropositivityInfectious Disease Transmission, VerticalAcyclovirAntiviral AgentsCytomegalovirus InfectionsFemaleHumansInfantInfant, NewbornMilk, HumanPregnancyPremedicationTreatment OutcomeValacyclovirValineAcyclovirAntiviral AgentsValacyclovirValine

Identifiers

PMID24504006
PMCPMC3913686
OpenAlexW2098604179

What OpenQuestion holds

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LicenceCC BY
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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.