Evidence map›Paper›PMID 38592950›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024

Clinical Outcomes in Children With Human Immunodeficiency Virus Treated for Nonsevere Tuberculosis in the SHINE Trial.

Chishala Chabala, Eric Wobudeya, Marieke M van der Zalm, Monica Kapasa, Priyanka Raichur, Robert Mboizi, Megan Palmer, Aarti Kinikar, Syed Hissar, Veronica Mulenga and 8 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.3field-weighted citation impact, top 12% 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.

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

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. 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

18 authors at 7 institutions in 6 countries.

Chishala ChabalaDepartment of Paediatrics, School of Medicine, University of Zambia, Lusaka, Zambia.ORCID 0000-0002-5551-5752
Eric WobudeyaMulago Hospital, Makerere University-John Hopkins Hospital Research Collaboration, Kampala, Uganda.ORCID 0000-0001-9574-5539
Marieke M van der ZalmDepartment of Paediatrics and Child Health, Desmond Tutu TB Centre, Stellenbosch University, Cape Town, South Africa.
Monica KapasaChildren's Hospital, University Teaching Hospitals, Lusaka, Zambia.
Priyanka RaichurByramjee Jeejeebhoy Medical College, Johns Hopkins University Clinical Research Site, Pune, India.ORCID 0000-0001-7938-3398
Robert MboiziMulago Hospital, Makerere University-John Hopkins Hospital Research Collaboration, Kampala, Uganda.
Megan PalmerDepartment of Paediatrics and Child Health, Desmond Tutu TB Centre, Stellenbosch University, Cape Town, South Africa.ORCID 0000-0002-2534-2483
Aarti KinikarByramjee Jeejeebhoy Medical College, Johns Hopkins University Clinical Research Site, Pune, India.ORCID 0000-0001-9466-1130
Syed HissarIndian Council of Medical Research, National Institute for Research in Tuberculosis, Chennai, India.
Veronica MulengaDepartment of Paediatrics, School of Medicine, University of Zambia, Lusaka, Zambia.ORCID 0000-0003-1843-8169
Vidya MaveByramjee Jeejeebhoy Medical College, Johns Hopkins University Clinical Research Site, Pune, India.ORCID 0000-0001-8509-4517
Philippa MusokeMulago Hospital, Makerere University-John Hopkins Hospital Research Collaboration, Kampala, Uganda.
Anneke C HesselingDepartment of Paediatrics and Child Health, Desmond Tutu TB Centre, Stellenbosch University, Cape Town, South Africa.ORCID 0000-0001-9399-9834
Helen McIlleronFaculty of Health Sciences, Department of Medicine, Division of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-0982-6226
Diana GibbInstitute of Clinical Trials and Methodology, Medical Research Council-Clinical Trials Unit at University College London, London, United Kingdom.ORCID 0000-0002-9738-5490
Angela CrookInstitute of Clinical Trials and Methodology, Medical Research Council-Clinical Trials Unit at University College London, London, United Kingdom.ORCID 0000-0002-6174-8747
Anna TurkovaInstitute of Clinical Trials and Methodology, Medical Research Council-Clinical Trials Unit at University College London, London, United Kingdom.
SHINE Trial Team
MRC Clinical Trials Unit at UCL · GBDesmond Tutu HIV Foundation · ZAMulago Hospital · UGUniversity of Cape Town · ZAJohns Hopkins University · USUniversity Teaching Hospital · ZMIndian Council of Medical Research · IN

Funding

Joint Global Health Trials SchemeMedical Research Council MR/L004445/1UK Medical Research Council MR/L004445/1Wellcome Trust
6 · The paper itself

Abstract

backgroundChildren with human immunodeficiency virus (HIV, CWH) are at high risk of tuberculosis (TB) and face poor outcomes, despite antiretroviral therapy (ART). We evaluated outcomes in CWH and children not living with HIV treated for nonsevere TB in the SHINE trial.

methodsSHINE was a randomized trial that enrolled children aged <16 years with smear-negative, nonsevere TB who were randomized to receive 4 versus 6 months of TB treatment and followed for 72 weeks. We assessed TB relapse/recurrence, mortality, hospitalizations, grade ≥3 adverse events by HIV status, and HIV virological suppression in CWH.

resultsOf 1204 children enrolled, 127 (11%) were CWH, of similar age (median, 3.6 years; interquartile range, 1.2, 10.3 versus 3.5 years; 1.5, 6.9; P = .07) but more underweight (weight-for-age z score, -2.3; (3.3, -0.8 versus -1.0; -1.8, -0.2; P < .01) and anemic (hemoglobin, 9.5 g/dL; 8.7, 10.9 versus 11.5 g/dL; 10.4, 12.3; P < .01) compared with children without HIV. A total of 68 (54%) CWH were ART-naive; baseline median CD4 count was 719 cells/mm3 (241-1134), and CD4% was 16% (10-26). CWH were more likely to be hospitalized (adjusted odds ratio, 2.4; 1.3-4.6) and to die (adjusted hazard ratio [aHR], 2.6; 95% confidence interval [CI], 1.2 to 5.8). HIV status, age <3 years (aHR, 6.3; 1.5, 27.3), malnutrition (aHR, 6.2; 2.4, 15.9), and hemoglobin <7 g/dL (aHR, 3.8; 1.3,11.5) independently predicted mortality. Among children with available viral load (VL), 45% and 61% CWH had VL <1000 copies/mL at weeks 24 and 48, respectively. There was no difference in the effect of randomized treatment duration (4 versus 6 months) on TB treatment outcomes by HIV status (P for interaction = 0.42).

conclusionsWe found no evidence of a difference in TB outcomes between 4 and 6 months of treatment for CWH treated for nonsevere TB. Irrespective of TB treatment duration, CWH had higher rates of mortality and hospitalization than their counterparts without HIV. Clinical Trials Registration. ISRCTN63579542.

Indexed as

Antitubercular AgentsHIV InfectionsTuberculosisAdolescentAnti-HIV AgentsCD4 Lymphocyte CountChildChild, PreschoolFemaleHospitalizationHumansInfantMaleRecurrenceTreatment OutcomeViral LoadAnti-HIV AgentsAntitubercular Agentsadverse eventschildren with HIVmortalitytuberculosisviral suppression

Identifiers

PMID38592950
PMCPMC11259218
OpenAlexW4394594731

What OpenQuestion holds

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LicenceCC BY
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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.