Evidence map›Paper›PMID 32661003›Full record

ArticleAntimicrobial agents and chemotherapy2020

Effect of Pregnancy on Unbound Raltegravir Concentrations in the ANRS 160 RalFe Trial.

Yi Zheng, Déborah Hirt, Sandrine Delmas, Gabrielle Lui, Sihem Benaboud, Jerome Lechedanec, Jean-Marc Tréluyer, Camille Chenevier-Gobeaux, Elisa Arezes, Ambre Gelley and 6 more

Abstract readMulticenter Study
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2020. 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. Observational
  3. Long-Acting Injectable Cabotegravir and Rilpivirine in a Pregnant Woman With HIV.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Article
  4. Article
  5. HIV-1 Integrase Strand Transfer Inhibitors and Neurodevelopment.Pharmaceuticals (Basel, Switzerland) · 2022
    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

16 authors.

Yi ZhengService de Pharmacologie Clinique, AP-HP, Hôpital Cochin, Paris, France.
Déborah HirtService de Pharmacologie Clinique, AP-HP, Hôpital Cochin, Paris, France deborah.hirt@aphp.fr.ORCID 0000-0002-9898-2609
Sandrine DelmasService d'Epidémiologie et Santé Publique, AP-HP, Hôpital Bicêtre, Le Kremlin-Bicêtre, France.
Gabrielle LuiService de Pharmacologie Clinique, AP-HP, Hôpital Cochin, Paris, France.
Sihem BenaboudService de Pharmacologie Clinique, AP-HP, Hôpital Cochin, Paris, France.
Jerome LechedanecService d'Epidémiologie et Santé Publique, AP-HP, Hôpital Bicêtre, Le Kremlin-Bicêtre, France.
Jean-Marc TréluyerService de Pharmacologie Clinique, AP-HP, Hôpital Cochin, Paris, France.
Camille Chenevier-GobeauxService de Diagnostic Biologique Automatisé, AP-HP, Hôpital Cochin, Paris, France.
Elisa ArezesService d'Epidémiologie et Santé Publique, AP-HP, Hôpital Bicêtre, Le Kremlin-Bicêtre, France.
Ambre GelleyANRS, France Recherche Nord&Sud Sida-hiv Hépatites, Paris, France.
Imane AmriANRS, France Recherche Nord&Sud Sida-hiv Hépatites, Paris, France.
Saïk UrienEA7323, Université de Paris, Paris, France.
Naïm BouazzaEA7323, Université de Paris, Paris, France.
Frantz FoissacEA7323, Université de Paris, Paris, France.
Josiane WarszawskiInserm 1018 CESP, Hôpital Bicêtre, Le Kremlin-Bicêtre, France.
Jade GhosnService des Maladies Infectieuses et Tropicales, AP-HP, Hôpitaux Universitaires Paris Nord Val de Seine, site Bichat-Claude Bernard, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A population pharmacokinetic model was developed to explore the pharmacokinetics modification of unbound raltegravir during pregnancy. The RalFe ANRS160 study was a nonrandomized, open-label, multicenter trial enrolling HIV-infected pregnant women receiving a combined antiretroviral regimen containing 400 mg raltegravir twice daily. Biological samples were collected during the third trimester of pregnancy (between 30 and 37 weeks of gestational age) and at postpartum (4 to 6 weeks after delivery). A population pharmacokinetic model was developed with Monolix software. A total of 360 plasma samples were collected from 43 women during pregnancy and postpartum. The unbound raltegravir was described by a one-compartment model with a transit compartment with first-order absorption, evolving to bound raltegravir (by a linear binding to albumin) or metabolism to RAL-glucuronide or to a first-order elimination, with a circadian rhythm. During pregnancy, the absorption was decreased and delayed and the raltegravir elimination clearance and glucuronidation increased by 37%. Median total and unbound area under the curve from 0 to 12 h significantly decreased by 36% and 27% during pregnancy. Median total trough concentration (

Indexed as

Anti-HIV AgentsHIV InfectionsPregnancy Complications, InfectiousFemaleHumansPostpartum PeriodPregnancyPregnancy Trimester, ThirdRaltegravir PotassiumAnti-HIV AgentsRaltegravir PotassiumHIVpopulation pharmacokineticspregnant womenraltegravirunbound concentrations

Identifiers

PMID32661003
PMCPMC7508578

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.