Evidence map›Paper›PMID 28079918›Full record

Trial reportBritish journal of clinical pharmacology2017

Dose evaluation of lamivudine in human immunodeficiency virus-infected children aged 5 months to 18 years based on a population pharmacokinetic analysis.

Esther J H Janssen, Diane E T Bastiaans, Pyry A J Välitalo, Annemarie M C van Rossum, Evelyne Jacqz-Aigrain, Hermione Lyall, Catherijne A J Knibbe, David M Burger

Abstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
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

8 authors.

Esther J H JanssenDivision of Pharmacology, Leiden Academic Centre for Drug Research, Leiden University, Leiden, the Netherlands.
Diane E T BastiaansDepartment of Pharmacy & Radboud Institute for Health Sciences (RIHS), Radboud University Medical Center, Nijmegen, the Netherlands.
Pyry A J VälitaloDivision of Pharmacology, Leiden Academic Centre for Drug Research, Leiden University, Leiden, the Netherlands.
Annemarie M C van RossumDivision of Pediatric Infectious Diseases and Immunology, Erasmus MC/Sophia, Rotterdam, the Netherlands.
Evelyne Jacqz-AigrainDepartment of Pediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, Université Paris VII, Paris, France.
Hermione LyallDepartment of Pediatrics, St Mary's Hospital, London, UK.
Catherijne A J KnibbeDivision of Pharmacology, Leiden Academic Centre for Drug Research, Leiden University, Leiden, the Netherlands.
David M BurgerDepartment of Pharmacy & Radboud Institute for Health Sciences (RIHS), Radboud University Medical Center, Nijmegen, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThe objectives of this study were to characterize age-related changes in lamivudine pharmacokinetics in children and evaluate lamivudine exposure, followed by dose recommendations for subgroups in which target steady state area under the daily plasma concentration-time curve (AUC

methodsPopulation pharmacokinetic modelling was performed in NONMEM using data from two model-building datasets and two external datasets [n = 180 (age 0.4-18 years, body weight 3.4-60.5 kg); 2061 samples (median 12 per child); daily oral dose 60-300 mg (3.9-17.6 mg kg

resultsA two-compartment model with sequential zero order and first order absorption best described the data. Apparent clearance and central volume of distribution (% RSE) were 13.2 l h

conclusionBodyweight best predicted the developmental changes in apparent lamivudine clearance and volume of distribution. For children aged 5 months-18 years with a body weight <14 kg, the dose should be increased from 8 to 10 mg kg

Indexed as

AdolescentAnti-HIV AgentsArea Under CurveBiological AvailabilityBody WeightChildChild, PreschoolDose-Response Relationship, DrugFemaleHIV InfectionsHumansInfantLamivudineMaleModels, StatisticalPopulationAnti-HIV AgentsLamivudinehuman immunodeficiency virus/acquired immune deficiency syndromemodelling and simulationpaediatricspharmacotherapytherapeutic drug monitoring

Identifiers

PMID28079918
PMCPMC5427247

What OpenQuestion holds

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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.