Evidence map›Paper›PMID 20554983›Full record

Trial reportThe New England journal of medicine2010

Antiretroviral regimens in pregnancy and breast-feeding in Botswana.

R L Shapiro, M D Hughes, A Ogwu, D Kitch, S Lockman, C Moffat, J Makhema, S Moyo, I Thior, K McIntosh and 20 more

2 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 264 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
264citing papers in PubMed, 14 pooled it
30.3field-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.

NCT00270296 phase2completednot on this map

Lopinavir/Ritonavir/Combivir vs. Abacavir/Zidovudine/Lamivudine for Virologic Efficacy and the Prevention of Mother-to-Child HIV Transmission Among Breastfeeding Women With CD4 Counts Greater Than or Equal to 200 Cells/mm3 in Botswana

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2006 to 2010Enrolled730ConditionsHIV InfectionsArmsTrizivir, Lamivudine/Zidovudine, Lopinavir/Ritonavir, Nevirapine
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

264 citing papers in PubMed, 14 syntheses or guidelines pooled it, 517 citations in OpenAlex.

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  13. Antiretroviral interventions for preventing breast milk transmission of HIV.The Cochrane database of systematic reviews · 2014
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204 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

30 authors at 11 institutions in 4 countries.

R L ShapiroDivision of Infectious Diseases, Beth Israel Deaconess Medical Center, 110 Francis St., Suite GB, Boston, MA 02215, USA. rshapiro@hsph.harvard.edu
M D Hughes
A Ogwu
D Kitch
S Lockman
C Moffat
J Makhema
S Moyo
I Thior
K McIntosh
E van Widenfelt
J Leidner
K Powis
A Asmelash
E Tumbare
S Zwerski
U Sharma
E Handelsman
K Mburu
O Jayeoba
E Moko
S Souda
E Lubega
M Akhtar
C Wester
R Tuomola
W Snowden
M Martinez-Tristani
L Mazhani
M Essex
Botswana Harvard AIDS Institute Partnership · BWHarvard University · USNational Institute of Allergy and Infectious Diseases · USAbbott Fund · USBeth Israel Deaconess Medical Center · USBrigham and Women's Hospital · USChildren's Hospital · TNGlaxoSmithKline (United Kingdom) · GBMassachusetts General Hospital · USMinistry of Health · BWNational Institutes of Health · US

Funding

INTERNATIONAL TRAINING IN AIDS-RELATED EPIDEMIOLOGYD43TW000004 · FIC · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI ESSEX, MYRON E · 1988 to 2012
$13.4M
HAART to Prevent HIV Transmission to Infants In BotswanaU01AI066454 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI SHAPIRO, ROGER L · 2005 to 2010
$5.3M
FIC NIH HHS D43 TW000004FIC NIH HHS D43 TW00004NIAID NIH HHS U01 AI066454NIAID NIH HHS U01-AI066454
6 · The paper itself

Abstract

backgroundThe most effective highly active antiretroviral therapy (HAART) to prevent mother-to-child transmission of human immunodeficiency virus type 1 (HIV-1) in pregnancy and its efficacy during breast-feeding are unknown.

methodsWe randomly assigned 560 HIV-1-infected pregnant women (CD4+ count, > or = 200 cells per cubic millimeter) to receive coformulated abacavir, zidovudine, and lamivudine (the nucleoside reverse-transcriptase inhibitor [NRTI] group) or lopinavir-ritonavir plus zidovudine-lamivudine (the protease-inhibitor group) from 26 to 34 weeks' gestation through planned weaning by 6 months post partum. A total of 170 women with CD4+ counts of less than 200 cells per cubic millimeter received nevirapine plus zidovudine-lamivudine (the observational group). Infants received single-dose nevirapine and 4 weeks of zidovudine.

resultsThe rate of virologic suppression to less than 400 copies per milliliter was high and did not differ significantly among the three groups at delivery (96% in the NRTI group, 93% in the protease-inhibitor group, and 94% in the observational group) or throughout the breast-feeding period (92% in the NRTI group, 93% in the protease-inhibitor group, and 95% in the observational group). By 6 months of age, 8 of 709 live-born infants (1.1%) were infected (95% confidence interval [CI], 0.5 to 2.2): 6 were infected in utero (4 in the NRTI group, 1 in the protease-inhibitor group, and 1 in the observational group), and 2 were infected during the breast-feeding period (in the NRTI group). Treatment-limiting adverse events occurred in 2% of women in the NRTI group, 2% of women in the protease-inhibitor group, and 11% of women in the observational group.

conclusionsAll regimens of HAART from pregnancy through 6 months post partum resulted in high rates of virologic suppression, with an overall rate of mother-to-child transmission of 1.1%. (ClinicalTrials.gov number, NCT00270296.)

Indexed as

Antiretroviral Therapy, Highly ActiveBreast FeedingHIV-1AdultCD4 Lymphocyte CountFemaleFollow-Up StudiesHIV InfectionsHIV Protease InhibitorsHumansInfantInfant, NewbornInfectious Disease Transmission, VerticalMaleNeutropeniaNevirapineHIV Protease InhibitorsNevirapineRNA, ViralZidovudine

Identifiers

PMID20554983
PMCPMC2999916
OpenAlexW2116914456

What OpenQuestion holds

Textmetadata
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.