Evidence map›Paper›PMID 20516271›Full record

Trial reportAntimicrobial agents and chemotherapy2010

Is the recommended once-daily dose of lamivudine optimal in West African HIV-infected children?

Naïm Bouazza, Déborah Hirt, Christophe Bardin, Serge Diagbouga, Boubacar Nacro, Hervé Hien, Emmanuelle Zoure, François Rouet, Adama Ouiminga, Stephane Blanche and 4 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Article
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

14 authors.

Naïm BouazzaEA 3620, Université Paris-Descartes, Unité de Recherche Clinique, Hôpital Tarnier, 89 Rue d'Assas, 75006 Paris, France. naim.bouazza@cch.aphp.fr
Déborah Hirt
Christophe Bardin
Serge Diagbouga
Boubacar Nacro
Hervé Hien
Emmanuelle Zoure
François Rouet
Adama Ouiminga
Stephane Blanche
Philippe Van De Perre
Jean-Marc Tréluyer
Philippe Msellati
Saik Urien

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We aimed in this study to describe lamivudine concentration-time courses in treatment-naïve children after once-daily administration, to study the effects of body weight and age on lamivudine pharmacokinetics, and to simulate an optimized administration scheme. For this purpose, lamivudine concentrations were measured in 49 children after at least 2 weeks of didanosine-lamivudine-efavirenz treatment. A total of 148 plasma lamivudine concentrations were measured, and a population pharmacokinetic model was developed with NONMEM. The influence of individual characteristics was tested using a likelihood ratio test. Children were divided into two groups, according to their pharmacokinetic parameters, thanks to tree regression analysis. For each patient, the area under the curve was derived from estimated individual pharmacokinetic parameters. Different once-daily doses were simulated in each group, to obtain the same exposure in children as the mean effective exposure in adults (8.9 mg/liter.h). A two-compartment model in which the slope of distribution is assumed to be equal to the absorption rate constant adequately described the data. Parameter estimates were standardized for a mean standard body weight using an allometric model. Children were then divided into 2 groups according to body weight: CL/F was significantly higher in children weighing less than 17 kg (1.12 liters/h/kg) than in children over 17 kg (0.95 liters/h/kg; P=0.01). The target mean AUC of 8.9 mg/liters.h was obtained with a 10-mg/kg once-daily lamivudine (3TC) dose for children below 17 kg; the recommended dose of 8 mg/kg seems to be sufficient in children weighing more than 17 kg. These assumptions should be prospectively confirmed.

Indexed as

AdolescentAfrica, WesternAlkynesAnti-HIV AgentsArea Under CurveBenzoxazinesChildChild, PreschoolCyclopropanesDidanosineDrug Administration ScheduleDrug Therapy, CombinationFemaleHIV InfectionsHumansLamivudineAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesDidanosineefavirenzLamivudineReverse Transcriptase Inhibitors

Identifiers

PMID20516271
PMCPMC2916343

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.