Evidence map›Paper›PMID 41504451›Full record

Observational studyMicrobiology spectrum2026

Dolutegravir concentrations in children receiving 3-month weekly isoniazid and rifapentine (3HP) for tuberculosis prevention.

Ruvarashe J Madzime, Louvina van der Laan, Samantha du Toit, Shaun Barnabas, Ingrid Courtney, Nicole E Brown, Rada Savic, Belen P Solans, Meredith G Dixon, Lufina Tsirizani and 4 more

Registry-linked trialAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Microbiology spectrum, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03730181 (Phase I/II Dose Finding and Safety Study of Rifapentine and Isoniazid in HIV-Infected and HIV-Uninfected Children With Latent Tuberculosis Infection), which is not on this map. Not yet cited in PubMed.

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

NCT03730181 phase1 / phase2completednot on this map

Phase I/II Dose Finding and Safety Study of Rifapentine and Isoniazid in HIV-Infected and HIV-Uninfected Children With Latent Tuberculosis Infection

TypeinterventionalSponsorCenters for Disease Control and PreventionRan2019 to 2025Enrolled69ConditionsLatent TuberculosisArmsRifapentine, Isoniazid
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Ruvarashe J MadzimeDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Rondebosch, South Africa.ORCID 0000-0001-9136-7657
Louvina van der LaanDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa.ORCID 0000-0002-3584-7477
Samantha du ToitFAMCRU, Department of Paediatrics and Child Health Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa.
Shaun BarnabasFAMCRU, Department of Paediatrics and Child Health Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa.
Ingrid CourtneyDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa.
Nicole E BrownDivision of Tuberculosis Elimination, Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA.
Rada SavicDepartment of Bioengineering and Therapeutic Sciences, University of San Francisco Schools of Pharmacy and Medicine, San Francisco, California, USA.
Belen P SolansDepartment of Bioengineering and Therapeutic Sciences, University of San Francisco Schools of Pharmacy and Medicine, San Francisco, California, USA.ORCID 0000-0003-4621-5480
Meredith G DixonDivision of Tuberculosis Elimination, Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA.
Lufina TsirizaniDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Rondebosch, South Africa.
Paolo DentiDivision of Clinical Pharmacology, Department of Medicine, University of Cape Town, Rondebosch, South Africa.ORCID 0000-0001-7494-079X
Rosanna BoydDivision of Tuberculosis Elimination, Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA.
Anneke C HesselingDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Stellenbosch, South Africa.ORCID 0000-0001-9399-9834
TBTC Study 35 team

Funding

Stellenbosch University Clinical Trial Unit, Cape Town, South AfricaUM1AI069521 · NIAID · STELLENBOSCH UNIVERSITY · PI Shaun Barnabas, Anneke Catharina Hesseling · 2012 to 2026
$21.5M
CDC HHSNIAID NIH HHS UM1 AI069521
6 · The paper itself

Abstract

In Tuberculosis Trials Consortium Study 35, which investigated the optimal dosing and safety of once-weekly isoniazid and rifapentine (3HP) in 69 children requiring tuberculosis preventive therapy, 7 children with HIV received 50 mg of once-daily dolutegravir. Plasma dolutegravir concentrations were consistent with those predicted in children on dolutegravir not receiving 3HP or potential metabolic inducers. All participants maintained viral suppression. Despite the expected induction effect of 3HP, results suggest that dolutegravir dose adjustments are not required.IMPORTANCEThis work describes the observed concentrations of dolutegravir in children co-administering rifapentine and dolutegravir. The work compares these concentrations with the model-simulated concentrations of a model developed using children not taking rifapentine or other metabolically inducing agents but who were administering dolutegravir. These data are the first available in children and are valuable in understanding the interaction of dolutegravir and rifapentine in children.CLINICAL TRIALSThis study is registered with the Tuberculosis Trials Consortium Study 35 as NCT03730181.

Indexed as

Antitubercular AgentsHeterocyclic Compounds, 3-RingIsoniazidRifampinTuberculosisChildChild, PreschoolDolutegravirFemaleHIV InfectionsHumansMaleOxazinesPiperazinesPyridonesAntitubercular AgentsDolutegravirHeterocyclic Compounds, 3-RingIsoniazidOxazinesPiperazinesPyridonesRifampinrifapentinechildrendolutegravirHIVpharmacokineticsrifapentinetuberculosis

Identifiers

PMID41504451
PMCPMC12889135

What Socratic holds

Textmetadata
Read underepoch 390

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 Socratic graph.