Evidence map›Paper›PMID 20554982›Full record

Trial reportThe New England journal of medicine2010

Maternal or infant antiretroviral drugs to reduce HIV-1 transmission.

Charles S Chasela, Michael G Hudgens, Denise J Jamieson, Dumbani Kayira, Mina C Hosseinipour, Athena P Kourtis, Francis Martinson, Gerald Tegha, Rodney J Knight, Yusuf I Ahmed and 13 more

2 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2010. 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 227 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
227citing papers in PubMed, 3 pooled it
31.2field-weighted citation impact, top 1% 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.

NCT00164736 phase3completednot on this map

HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health

TypeinterventionalSponsorCenters for Disease Control and PreventionRan2004 to 2010Enrolled2,369ConditionsHIV InfectionsArmsMaternal zidovudine/lamivudine/lopinavir-ritonavir, Infant nevirapine, Maternal protein and calorie supplement
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

227 citing papers in PubMed, 3 syntheses or guidelines pooled it, 435 citations in OpenAlex.

  1. Pooled it
  2. Antiretroviral interventions for preventing breast milk transmission of HIV.The Cochrane database of systematic reviews · 2014
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  9. Assessment of Nevirapine Prophylactic and Therapeutic Dosing Regimens for Neonates.Journal of acquired immune deficiency syndromes (1999) · 2017
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167 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 1 institution in 1 country.

Charles S ChaselaUniversity of North Carolina Project, Lilongwe, Malawi.
Michael G Hudgens
Denise J Jamieson
Dumbani Kayira
Mina C Hosseinipour
Athena P Kourtis
Francis Martinson
Gerald Tegha
Rodney J Knight
Yusuf I Ahmed
Deborah D Kamwendo
Irving F Hoffman
Sascha R Ellington
Zebrone Kacheche
Alice Soko
Jeffrey B Wiener
Susan A Fiscus
Peter Kazembe
Innocent A Mofolo
Maggie Chigwenembe
Dorothy S Sichali
Charles M van der Horst
BAN Study Group
Principia Ingenieros Consultores · ES

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
UNC Center for Health Promotion and Disease PreventionU48DP000059 · DP · UNIV OF NORTH CAROLINA CHAPEL HILL · PI AMMERMAN, ALICE S · 2004 to 2009
$14.4M
Carolina Population CenterR24HD050924 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MORGAN, SAMUEL PHILIP · 2005 to 2014
$10.0M
AIDS INTERNATIONAL TRAINING AND RESEARCH PROGRAMD43TW001039 · FIC · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ADIMORA, ADAORA A · 1998 to 2013
$9.9M
FIC NIH HHS 2-D43 TW01039-06FIC NIH HHS D43 TW001039NCCDPHP CDC HHS SIP 26-04 U48-DP000059-01NCCDPHP CDC HHS U48 DP000059NIAID NIH HHS P30 AI050410NIAID NIH HHS P30-AI50410NICHD NIH HHS R24 HD050924PHS HHS SIP 13-01 U48-CCU409660-09
6 · The paper itself

Abstract

backgroundWe evaluated the efficacy of a maternal triple-drug antiretroviral regimen or infant nevirapine prophylaxis for 28 weeks during breast-feeding to reduce postnatal transmission of human immunodeficiency virus type 1 (HIV-1) in Malawi.

methodsWe randomly assigned 2369 HIV-1-positive, breast-feeding mothers with a CD4+ lymphocyte count of at least 250 cells per cubic millimeter and their infants to receive a maternal antiretroviral regimen, infant nevirapine, or no extended postnatal antiretroviral regimen (control group). All mothers and infants received perinatal prophylaxis with single-dose nevirapine and 1 week of zidovudine plus lamivudine. We used the Kaplan-Meier method to estimate the cumulative risk of HIV-1 transmission or death by 28 weeks among infants who were HIV-1-negative 2 weeks after birth. Rates were compared with the use of the log-rank test.

resultsAmong mother-infant pairs, 5.0% of infants were HIV-1-positive at 2 weeks of life. The estimated risk of HIV-1 transmission between 2 and 28 weeks was higher in the control group (5.7%) than in either the maternal-regimen group (2.9%, P=0.009) or the infant-regimen group (1.7%, P<0.001). The estimated risk of infant HIV-1 infection or death between 2 and 28 weeks was 7.0% in the control group, 4.1% in the maternal-regimen group (P=0.02), and 2.6% in the infant-regimen group (P<0.001). The proportion of women with neutropenia was higher among those receiving the antiretroviral regimen (6.2%) than among those in either the nevirapine group (2.6%) or the control group (2.3%). Among infants receiving nevirapine, 1.9% had a hypersensitivity reaction.

conclusionsThe use of either a maternal antiretroviral regimen or infant nevirapine for 28 weeks was effective in reducing HIV-1 transmission during breast-feeding. (ClinicalTrials.gov number, NCT00164736.)

Indexed as

Breast FeedingHIV-1AdultAnti-Retroviral AgentsCD4 Lymphocyte CountDrug HypersensitivityDrug Therapy, CombinationFemaleHIV InfectionsHIV SeronegativityHumansInfant, NewbornInfectious Disease Transmission, VerticalKaplan-Meier EstimateLamivudineMaleAnti-Retroviral AgentsLamivudineNevirapineZidovudine

Identifiers

PMID20554982
PMCPMC3440865
OpenAlexW2126184004

What OpenQuestion holds

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LicenceTDM
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.