Evidence map›Paper›PMID 25222305›Full record

Trial reportThe Pediatric infectious disease journal2014

Predictors of virologic and clinical response to nevirapine versus lopinavir/ritonavir-based antiretroviral therapy in young children with and without prior nevirapine exposure for the prevention of mother-to-child HIV transmission.

Jane C Lindsey, Michael D Hughes, Avy Violari, Susan H Eshleman, Elaine J Abrams, Mutsa Bwakura-Dangarembizi, Linda Barlow-Mosha, Portia Kamthunzi, Pauline M Sambo, Mark F Cotton and 10 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Pediatric infectious disease journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 15% 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

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Observational
  4. Article
  5. Article
  6. African Multi-Site 2-Year Neuropsychological Study of School-Age Children Perinatally Infected, Exposed, and Unexposed to Human Immunodeficiency Virus.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020
    Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Observational
  13. Getting to 90-90-90 in paediatric HIV: What is needed?Journal of the International AIDS Society · 2015
    Article
  14. Review
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

20 authors at 6 institutions in 7 countries.

Jane C LindseyFrom the *Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, MA; †University of Witwatersrand, Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, Johannesburg, South Africa; ‡Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD; §Department of Epidemiology, ICAP, Mailman School of Public Health and College of Physicians and Surgeons, Columbia University, New York, NY; ¶Department of Paediatrics and Child Health, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe; ‖Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda; **University of North Carolina Project, Lilongwe, Malawi; ††University Teaching Hospital, Lusaka, Zambia; ‡‡Division of Paediatrics and Infectious Diseases, Tygerberg Children's Hospital, Stellenbosch University, Tygerberg; §§University of the Witwatersrand Reproductive Health and HIV Institute, Faculty of Health Sciences, Johannesburg, South Africa; ¶¶Department of Pediatrics, BJ Medical College and Sassoon General Hospital, Pune, India; ‖‖Duke University-Kilimanjaro Christian Medical Center Collaboration, Moshi, Tanzania; ***Department of Paediatrics and Child Health, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa; †††Frontier Science and Technology Research Foundation, Amherst, NY; ‡‡‡Social and Scientific Systems, Durham, NC; §§§Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Rockville, MD; ¶¶¶HJF-DAIDS, a Division of The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Contractor to NIAID, NIH, DHHS, Bethesda, MD; and ‖‖‖Division of Infectious Diseases and International Health, Geisel School of Medicine at Dartmouth, One Medical Center Drive, Lebanon, NH.
Michael D Hughes
Avy Violari
Susan H Eshleman
Elaine J Abrams
Mutsa Bwakura-Dangarembizi
Linda Barlow-Mosha
Portia Kamthunzi
Pauline M Sambo
Mark F Cotton
Harry Moultrie
Sandhya Khadse
Werner Schimana
Raziya Bobat
Bonnie Zimmer
Elizabeth Petzold
Lynne M Mofenson
Patrick Jean-Philippe
Paul Palumbo
P1060 Study Team
Johns Hopkins University · USCancer Research And Biostatistics · USChris Hani Baragwanath Hospital · ZADartmouth College · USHenry M. Jackson Foundation · USNational Institutes of Health · US

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
Soweto Clinical Trials UnitUM1AI069453 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI Glenda E Gray, Lerato Mohapi · 2012 to 2026
$40.9M
Statistical/Data Management Center-Pediatric AIDS CTGU01AI041110 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI FENTON, TERRENCE · 1997 to 2006
$38.6M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGU01AI068616 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI SHAPIRO, DAVID ERIC · 2006 to 2010
$38.6M
The Johns Hopkins University - Uganda Clinical Trials UnitUM1AI069530 · NIAID · JOHNS HOPKINS UNIVERSITY · PI MARY Glenn Fowler, Philippa Musoke · 2012 to 2026
$34.8M
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI REES, HELEN, SANNE, IAN MATTHIAS · 2012 to 2025
$31.8M
NIAID NIH HHS 1 U01 AI068616NIAID NIH HHS 5 U01 AI41110NIAID NIH HHS U01 AI041110NIAID NIH HHS U01 AI068616NIAID NIH HHS U01 AI068632NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069453NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069530
6 · The paper itself

Abstract

backgroundIn a randomized trial comparing nevirapine (NVP)-based versus lopinavir/ritonavir (LPV/r)-based antiretroviral therapy (ART) in HIV-infected children [primary endpoint discontinuation of study treatment for any reason or virologic failure by week 24] aged 2 months to 3 years, we assessed whether clinical, virologic, immunologic and safety outcomes varied by prior single-dose NVP exposure (PrNVP) for prevention of mother-to-child HIV transmission and other covariates.

methodsEfficacy was assessed by time to ART discontinuation or virologic failure, virologic failure/death and death; safety by time to ART discontinuation because of a protocol-defined toxicity and first ≥ grade 3 adverse event; immunology and growth by changes in CD4%, weight/height World Health Organization z-scores from entry to week 48. Cox proportional hazards and linear regression models were used to test whether treatment differences depended on PrNVP exposure and other covariates.

resultsOver a median follow up of 48 (PrNVP) and 72 (no PrNVP) weeks, there was no evidence of differential treatment effects by PrNVP exposure or any other covariates. LPV/r-based ART was superior to NVP-based ART for efficacy and safety outcomes; however, those on NVP had larger improvements in CD4%, weight and height z-scores. Lower pretreatment CD4% and higher HIV-1 RNA levels were associated with reduced efficacy, lower pretreatment CD4% with shorter time to ART discontinuation because of a protocol-defined toxicity, and no PrNVP with shorter time to first grade ≥ 3 adverse event.

conclusionsDifferences between LPV/r and NVP ART in efficacy, safety, immunologic and growth outcomes did not depend on PrNVP exposure, prior breast-feeding, sex, HIV-1 subtype, age, pretreatment CD4%, HIV-1 RNA or World Health Organization disease stage. This finding should be considered when selecting an ART regimen for young children.

Indexed as

Africa South of the SaharaAnti-HIV AgentsChild, PreschoolFemaleHIV-1HIV InfectionsHumansIncidenceIndiaInfantInfant, NewbornInfectious Disease Transmission, VerticalLopinavirMaleNevirapineRitonavirAnti-HIV AgentsLopinavirNevirapineRitonavir

Identifiers

PMID25222305
PMCPMC4166566
OpenAlexW2317258756

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Registered trials

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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.