Evidence map›Paper›PMID 19114673›Full record

ArticleAntimicrobial agents and chemotherapy2009

Antiretroviral concentrations in breast-feeding infants of mothers receiving highly active antiretroviral therapy.

Mark Mirochnick, Timothy Thomas, Edmund Capparelli, Clement Zeh, Diane Holland, Rose Masaba, Prisca Odhiambo, Mary Glenn Fowler, Paul J Weidle, Michael C Thigpen

Registry-linked trialAbstract read
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04862975 (Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana), which is not on this map. Cited by 48 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 3 pooled it
3.7field-weighted citation impact, top 7% 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.

NCT04862975 completednot on this mapstarted 2024, after this paper: background citation

Pharmacokinetics of Antiretroviral Drugs in Lactating Women and Breastmilk Fed Infants Under 6 Months of Age in Botswana

TypeobservationalSponsorDuke UniversityRan2024 to 2025Enrolled164ConditionsLactating Women on Select DOI, Breastmilk Fed Infants of Mothers on Select DOI, HIV InfectionsArmsDolutegravir, Lamivudine, Emtricitabine, Tenofovir Disoproxil Fumarate
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 3 syntheses or guidelines pooled it, 119 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Antiretroviral interventions for preventing breast milk transmission of HIV.The Cochrane database of systematic reviews · 2014
    Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Increased risk of severe infant anemia after exposure to maternal HAART, Botswana.Journal of acquired immune deficiency syndromes (1999) · 2011
    Trial
  10. Trial
  11. Article
  12. Observational
  13. Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Importance of Prospective Studies in Pregnant and Breastfeeding Women Living With Human Immunodeficiency Virus.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019
    Article
  19. Article
  20. Article
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 3 countries.

Mark MirochnickBoston Medical Center, Boston University School of Medicine, Boston, Massachusetts 02118, USA. markm@bu.edu
Timothy Thomas
Edmund Capparelli
Clement Zeh
Diane Holland
Rose Masaba
Prisca Odhiambo
Mary Glenn Fowler
Paul J Weidle
Michael C Thigpen
Centers for Disease Control and Prevention · KEKenya Medical Research Institute · KENational Center for HIV/AIDS Viral Hepatitis STD and TB Prevention · USUniversity of California, San Diego · USBoston University · USMUJHU Research Collaboration · UG

Funding

Pediatric Pharmacology Research Unit NetworkU10HD031318 · NICHD · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI CAPPARELLI, EDMUND VINCENT · 2004 to 2009
$2.1M
Antiretroviral Pharmacology/Lactating Mother/InfantsR21HD051470 · NICHD · BOSTON MEDICAL CENTER · PI MIROCHNICK, MARK H · 2005 to 2006
$453k
NICHD NIH HHS 1R21HD051470-01NICHD NIH HHS 5U10 HD031318-14NICHD NIH HHS R21 HD051470NICHD NIH HHS U10 HD031318
6 · The paper itself

Abstract

There are limited data describing the concentrations of zidovudine, lamivudine, and nevirapine in nursing infants as a result of transfer via breast milk. The Kisumu Breastfeeding Study is a phase IIb open-label trial of prenatal, intrapartum, and postpartum maternal treatment with zidovudine, lamivudine, and nevirapine from 34 weeks of gestation to 6 months postpartum. In a pharmacokinetic substudy, maternal plasma, breast milk, and infant dried blood spots were collected for drug assay on the day of delivery and at 2, 6, 14, and 24 weeks after delivery. Sixty-seven mother-infant pairs were enrolled. The median concentrations in breast milk of zidovudine, lamivudine, and nevirapine during the study period were 14 ng/ml, 1,214 ng/ml, and 4,546 ng/ml, respectively. Zidovudine was not detectable in any infant plasma samples obtained after the day of delivery, while the median concentrations in infant plasma samples from postpartum weeks 2, 6, and 14 were 67 ng/ml, 32 ng/ml, and 24 ng/ml for lamivudine and 987 ng/ml, 1,032 ng/ml, and 734 ng/ml for nevirapine, respectively. Therefore, lamivudine and nevirapine, but not zidovudine, are transferred to infants via breast milk in biologically significant concentrations. The extent and effect of infant drug exposure via breast milk must be well understood in order to evaluate the benefits and risks of maternal antiretroviral use during lactation.

Indexed as

Breast FeedingAdolescentAdultAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveBloodClinical Trials, Phase II as TopicDesiccationFemaleHIV InfectionsHumansInfantInfectious Disease Transmission, VerticalLactationLamivudineNevirapineAnti-HIV AgentsLamivudineNevirapineReverse Transcriptase InhibitorsZidovudine

Identifiers

PMID19114673
PMCPMC2650559
OpenAlexW2112601356

What OpenQuestion holds

Textmetadata
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.