Evidence map›Paper›PMID 39066509›Full record

Trial reportJournal of the Pediatric Infectious Diseases Society2024

Population Pharmacokinetics of Dolutegravir in African Children: Results From the CHAPAS-4 Trial.

Hylke Waalewijn, Roeland E Wasmann, Alasdair Bamford, Diana M Gibb, Helen M McIlleron, Angela Colbers, David M Burger, Paolo Denti, CHAPAS-4 trial team

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the Pediatric Infectious Diseases Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. Observational
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

9 authors.

Hylke WaalewijnDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Roeland E WasmannDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-5769-8150
Alasdair BamfordMedical Research Council Clinical Trials Unit, University College London, London, UK.
Diana M GibbMedical Research Council Clinical Trials Unit, University College London, London, UK.
Helen M McIlleronDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-0982-6226
Angela ColbersDepartment of Pharmacy, Research Institute for Medical Innovation, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID 0000-0002-0389-9934
David M BurgerDepartment of Pharmacy, Research Institute for Medical Innovation, Radboud University Medical Center, Nijmegen, The Netherlands.
Paolo DentiDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa.ORCID 0000-0001-7494-079X
CHAPAS-4 trial team

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
European and Developing Countries Clinical Trials Partnership TRIA2015-1078Janssen Pharmaceuticals and Gilead Sciences IncNIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

We characterized population pharmacokinetics in 42 African children receiving once-daily 25 mg (14 to <20 kg) or 50 mg (>20 kg) dolutegravir. Coadministration with emtricitabine and tenofovir alafenamide reduced dolutegravir bioavailability by 19.6% (95% confidence interval: 8.13%-30.8%) compared with zidovudine or abacavir with lamivudine. Nevertheless, concentrations remained above efficacy targets, confirming current dosing recommendations.

Indexed as

Anti-HIV AgentsHeterocyclic Compounds, 3-RingHIV InfectionsOxazinesPiperazinesPyridonesAdenineAdolescentAlanineBiological AvailabilityChildChild, PreschoolDideoxynucleosidesDolutegravirDrug InteractionsDrug Therapy, CombinationAdenineAlanineAnti-HIV AgentsDideoxynucleosidesDolutegravirEmtricitabineHeterocyclic Compounds, 3-RingHIV Integrase InhibitorsLamivudineOxazinesPiperazinesPyridonesTenofovirZidovudinechildrendolutegravirHIVpharmacokineticpopulation pharmacokinetics

Identifiers

PMID39066509
PMCPMC11424990

What OpenQuestion holds

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Registered trials

None linked

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.