Evidence map›Paper›PMID 18525035›Full record

Trial reportThe New England journal of medicine2008

Extended antiretroviral prophylaxis to reduce breast-milk HIV-1 transmission.

Newton I Kumwenda, Donald R Hoover, Lynne M Mofenson, Michael C Thigpen, George Kafulafula, Qing Li, Linda Mipando, Kondwani Nkanaunena, Tsedal Mebrahtu, Marc Bulterys and 2 more

Erratum issued 2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 157 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
157citing papers in PubMed, 7 pooled it
30.5field-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.

NCT00115648 phase3completednot on this map

Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission

TypeinterventionalSponsorJohns Hopkins Bloomberg School of Public HealthRan2004 to 2009Enrolled3,300ConditionsHIV InfectionsArmsNevirapine, AZT, NVP and AZT, NVP, NVP+AZT
NCT01388452 nacompletednot on this mapstarted 2011, after this paper: background citation

Presumptive and Definitive Virologic HIV Diagnosis in Hospitalized Malawian Infants

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2011 to 2012Enrolled300ConditionsHIV InfectionsArmsPoint of care HIV RNA PCR
3 · Its place in the literature

Who cites it

157 citing papers in PubMed, 7 syntheses or guidelines pooled it, 401 citations in OpenAlex.

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  2. Antiretroviral interventions for preventing breast milk transmission of HIV.The Cochrane database of systematic reviews · 2014
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  18. Pooled individual data analysis of 5 randomized trials of infant nevirapine prophylaxis to prevent breast-milk HIV-1 transmission.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2013
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97 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 2 countries.

Newton I KumwendaBloomberg School of Public Health, Johns Hopkins University, Baltimore, MD 21205, USA.
Donald R Hoover
Lynne M Mofenson
Michael C Thigpen
George Kafulafula
Qing Li
Linda Mipando
Kondwani Nkanaunena
Tsedal Mebrahtu
Marc Bulterys
Mary Glenn Fowler
Taha E Taha
Johns Hopkins University · USJohns Hopkins Medicine · USUniversity of Malawi · MW

Funding

inter epi.research studies to reduce mother to child HIV-1 transU50PS022061 · PS · UNIVERSITY OF MALAWI · PI KUMWENDA, NEWTON ISAAC · 2005 to 2008
$2.5M
CDC HHS U50-CC0222061NCHHSTP CDC HHS 5-U50-PS022061-05
6 · The paper itself

Abstract

backgroundEffective strategies are urgently needed to reduce mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) through breast-feeding in resource-limited settings.

methodsWomen with HIV-1 infection who were breast-feeding infants were enrolled in a randomized, phase 3 trial in Blantyre, Malawi. At birth, the infants were randomly assigned to one of three regimens: single-dose nevirapine plus 1 week of zidovudine (control regimen) or the control regimen plus daily extended prophylaxis either with nevirapine (extended nevirapine) or with nevirapine plus zidovudine (extended dual prophylaxis) until the age of 14 weeks. Using Kaplan-Meier analyses, we assessed the risk of HIV-1 infection among infants who were HIV-1-negative on DNA polymerase-chain-reaction assay at birth.

resultsAmong 3016 infants in the study, the control group had consistently higher rates of HIV-1 infection from the age of 6 weeks through 18 months. At 9 months, the estimated rate of HIV-1 infection (the primary end point) was 10.6% in the control group, as compared with 5.2% in the extended-nevirapine group (P<0.001) and 6.4% in the extended-dual-prophylaxis group (P=0.002). There were no significant differences between the two extended-prophylaxis groups. The frequency of breast-feeding did not differ significantly among the study groups. Infants receiving extended dual prophylaxis had a significant increase in the number of adverse events (primarily neutropenia) that were deemed to be possibly related to a study drug.

conclusionsExtended prophylaxis with nevirapine or with nevirapine and zidovudine for the first 14 weeks of life significantly reduced postnatal HIV-1 infection in 9-month-old infants. (ClinicalTrials.gov number, NCT00115648.)

Indexed as

Breast FeedingHIV-1Anti-HIV AgentsDeveloping CountriesDrug Administration ScheduleDrug Therapy, CombinationFemaleHIV InfectionsHumansInfantInfant MortalityInfant, NewbornInfectious Disease Transmission, VerticalKaplan-Meier EstimateMalawiMaleAnti-HIV AgentsNevirapineZidovudine

Identifiers

PMID18525035
OpenAlexW2038183880

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.