Evidence map›Paper›PMID 23687222›Full record

Trial reportThe Journal of infectious diseases2013

Clinical and genetic determinants of plasma nevirapine exposure following an intrapartum dose to prevent mother-to-child HIV transmission.

Saran Vardhanabhuti, Edward P Acosta, Heather J Ribaudo, Patrice Severe, Umesh Lalloo, Nagalingeshwaran Kumarasamy, Frank Taulo, Joseph Kabanda, Olola Oneko, Prudence Ive and 7 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.7field-weighted citation impact, top 16% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 21 citations in OpenAlex.

  1. Pharmacogenetic predictors of nevirapine pharmacokinetics in Ghanaian children living with HIV with or without TB coinfection.Infection, genetics and evolution : journal of molecular epidemiology and evolutionary genetics in infectious diseases · 2021
    Trial
  2. HIV post-treatment controllers have distinct immunological and virological features.Proceedings of the National Academy of Sciences of the United States of America · 2023
    Article
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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

17 authors at 13 institutions in 7 countries.

Saran VardhanabhutiStatistical Data Analysis Center, Harvard School of Public Health, Boston, Massachusetts, USA.
Edward P Acosta
Heather J Ribaudo
Patrice Severe
Umesh Lalloo
Nagalingeshwaran Kumarasamy
Frank Taulo
Joseph Kabanda
Olola Oneko
Prudence Ive
Pradeep Sambarey
Ellen S Chan
Jane Hitti
Francis Hong
Deborah McMahon
David W Haas
A5207 ACTG Study Team
Harvard University · USUniversity of Pittsburgh · USB. J. Medical College & Sassoon Hospital · INGheskio Centers · HTJoint Clinical Research Centre · UGKilimanjaro Christian Medical Centre · TZUniversity of Alabama at Birmingham · USUniversity of KwaZulu-Natal · ZAUniversity of Malawi · MWUniversity of the Witwatersrand · ZAUniversity of Washington · USVanderbilt University · USYR Gaitonde Centre for AIDS Research and Education · IN

Funding

WOMEN'S HEALTH AGENDAU01AI038858 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI BENSON, CONSTANCE ANN · 1996 to 2008
$157.5M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
The Malawi Clinical Trials UnitU01AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI TAHA, TAHA E · 2007 to 2011
$46.7M
University of Pittsburgh Clinical Trials UnitUM1AI069494 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI SUSAN L KOLETAR, John W Mellors · 2012 to 2026
$38.0M
Units for HIV/AIDS Clinical Trials NetworksU01AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI SANNE, IAN MATTHIAS · 2007 to 2011
$24.2M
GHESKIO HIV Clinical Trial UnitUM1AI069421 · NIAID · GHESKIO CENTER · PI JEAN WILLIAM PAPE · 2012 to 2026
$23.6M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitU01AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BENSON, CONSTANCE ANN · 2007 to 2011
$19.3M
Case AIDS Clinical Trials UnitU01AI069501 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI LEDERMAN, MICHAEL MARCEL · 2007 to 2011
$14.7M
HIV/AIDS Clinical Trials UnitU01AI069484 · NIAID · DUKE UNIVERSITY · PI BARTLETT, JOHN A · 2007 to 2011
$14.6M
NIAID NIH HHS P30 AI054999NIAID NIH HHS P30 AI54999NIAID NIH HHS R01 AI077505NIAID NIH HHS U01 AI038858NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01 AI069417NIAID NIH HHS U01 AI069421NIAID NIH HHS U01 AI069426NIAID NIH HHS U01 AI069432NIAID NIH HHS U01 AI069439NIAID NIH HHS U01 AI069463NIAID NIH HHS U01 AI069484NIAID NIH HHS U01 AI069494NIAID NIH HHS U01 AI069501NIAID NIH HHS U01 AI069518NIAID NIH HHS U01 AI38858NIAID NIH HHS U01 AI69463NIAID NIH HHS UM1 AI069421NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

objectiveNevirapine is metabolized by cytochrome P450 (CYP) 2B6 and CYP3A4. We characterized relationships between clinical parameters, human genetics, pharmacokinetics, and human immunodeficiency virus type 1 (HIV-1) drug resistance mutations in pregnant women following single-dose intrapartum nevirapine.

methodsIn AIDS Clinical Trials Group study A5207, women received nevirapine at onset of labor and were randomly assigned to receive lamivudine/zidovudine, emtricitabine/tenofovir, or lopinavir/ritonavir for 7 or 21 days. Plasma nevirapine level was quantified on postpartum day 1 and on weeks 1, 3, and 5. We assayed 214 polymorphisms in CYP2B6 and other genes and evaluated associations with pharmacokinetic parameters, including elimination constant, time to protein-adjusted 50% inhibitory concentration (IC50), and week 5 nevirapine level below the quantification limit.

resultsAmong 301 women with evaluable pharmacokinetic and genotype data, lower body mass index and random assignment to receive lopinavir/ritonavir were associated with more rapid nevirapine elimination. Among those of African ancestry, longer time to IC50 was associated with CYP2B6 983T → C (P = .004) but not with CYP2B6 516G → T (P = .8). Among Indians, slower nevirapine elimination was associated with CYP2B6 516G → T (P = .04). Emergent resistance was infrequent and not associated with pharmacokinetics or CYP2B6 genotype.

conclusionsThe effects on plasma drug exposure following single-dose nevirapine may be greater for CYP2B6 983T → C than for 516G → T and are less pronounced than at steady state.

Indexed as

AdultAnti-HIV AgentsAryl Hydrocarbon HydroxylasesChemopreventionCytochrome P-450 CYP2B6FemaleHIV InfectionsHumansInfant, NewbornInfectious Disease Transmission, VerticalInhibitory Concentration 50MaleMetabolic Clearance RateNevirapineOxidoreductases, N-DemethylatingPlasmaAnti-HIV AgentsAryl Hydrocarbon HydroxylasesCYP2B6 protein, humanCytochrome P-450 CYP2B6NevirapineOxidoreductases, N-DemethylatingCYP2B6nevirapinepharmacogeneticspharmacokineticspregnancy

Identifiers

PMID23687222
PMCPMC3719905
OpenAlexW2120761049

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.