Evidence map›Paper›PMID 21564164›Full record

ArticleBritish journal of clinical pharmacology2011

Lopinavir/ritonavir population pharmacokinetics in neonates and infants.

Saik Urien, Ghislaine Firtion, Suzanne T Anderson, Deborah Hirt, Caroline Solas, Gilles Peytavin, Albert Faye, Isabelle Thuret, Marthe Leprevost, Carole Giraud and 4 more

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02348177 (A Pharmacokinetics Study Comparing Lopinavir Plasma Exposure When Given as Lopinavir/Ritonavir), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.3field-weighted citation impact, top 10% 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.

NCT02348177 phase4completednot on this mapstarted 2013, after this paper: background citation

A Pharmacokinetics Study Comparing Lopinavir Plasma Exposure When Given as Lopinavir/Ritonavir (1:1) in the Presence of Rifampicin and Lopinavir/Ritonavir (4:1) Without Rifampicin in HIV and TB Co-infected Children in South Africa.

TypeinterventionalSponsorDrugs for Neglected DiseasesRan2013 to 2016Enrolled96ConditionsAcquired Immunodeficiency Syndrome, TuberculosisArmslopinavir with ritonavir in 1:1 ratio, Lopinavir/ritonavir 4:1
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 31 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Observational
  6. Article
  7. Antiretroviral therapy during the neonatal period.Southern African journal of HIV medicine · 2015
    Article
  8. Article
  9. Getting to 90-90-90 in paediatric HIV: What is needed?Journal of the International AIDS Society · 2015
    Article
  10. 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 at 7 institutions in 3 countries.

Saik UrienEA 3620, Université Paris Descartes, Paris, France. saik.urien@svp.aphp.fr
Ghislaine Firtion
Suzanne T Anderson
Deborah Hirt
Caroline Solas
Gilles Peytavin
Albert Faye
Isabelle Thuret
Marthe Leprevost
Carole Giraud
Hermione Lyall
Saye Khoo
Stéphane Blanche
Jean-Marc Tréluyer
Délégation Paris 5 · FRAssistance Publique – Hôpitaux de Paris · FRHôpital de la Timone · FRBrighton and Sussex Medical School · GBImperial College Healthcare NHS Trust · GBLondon North West Healthcare NHS Trust · GBUniversity of Liverpool · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

what is already known about this subject• Lopinavir/ritonavir pharmacokinetics have been fully investigated in adults and children. WHAT THIS STUDY ADDS: • Lopinavir/ritonavir population pharmacokinetics in 96 neonates and infants from birth to less than 2 years (1.16 to 10.4 kg) showed that CL/F and V/F were dependent on body weight on an allometric basis and post-menstrual age.

aimsBecause of immature hepatic metabolism, lopinavir could present specific pharmacokinetics in the first weeks of life. We aimed at determining the optimal dosing regimen in neonates and infants weighing 1 to 10.5 kg.

methodsLopinavir/ritonavir (LPV/r) pharmacokinetics were studied in 96 infants using a population approach. RESULTS A one-compartment model described LPV/r pharmacokinetics. Normalized to a 70 kg adult using allometry, clearance (CL/F) and distribution volume (V/F) estimates were 5.87|h(-1) 70 kg(-1) and 91.7|70 kg(-1). The relative bioavailabilty, F, increased with post-menstrual age (PMA) and reached 50% of the adult value at 39.7 weeks.

conclusionsSize and PMA explained some CL/F and V/F variability in neonates/infants. Based upon trough concentration limitations, suggested LPV/r dosing regimens were 40 mg 12 h(-1), 80 mg 12 h(-1) and 120 mg 12 h(-1) in the 1-2 kg, 2-6 kg and 6-10 kg group, respectively.

Indexed as

Anti-HIV AgentsFemaleHIV Protease InhibitorsHumansInfantInfant, NewbornLopinavirMaleModels, BiologicalModels, StatisticalPyrimidinonesReverse Transcriptase InhibitorsRitonavirAnti-HIV AgentsHIV Protease InhibitorsLopinavirPyrimidinonesReverse Transcriptase InhibitorsRitonavir

Identifiers

PMID21564164
PMCPMC3099384
OpenAlexW1927513137

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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.