Evidence map›Paper›PMID 21943845›Full record

Trial reportThe international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease2011

Early antiretroviral treatment reduces risk of bacille Calmette-Guérin immune reconstitution adenitis.

H Rabie, A Violari, T Duong, S A Madhi, D Josipovic, S Innes, E Dobbels, E Lazarus, R Panchia, A G Babiker and 3 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 4 pooled it
1.2field-weighted citation impact, top 21% 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

26 citing papers in PubMed, 4 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Treating BCG-induced disease in children.The Cochrane database of systematic reviews · 2013
    Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Review
  11. BCG Vaccination and Mother-to-Infant Transmission of HIV.The Journal of infectious diseases · 2020
    Article
  12. Article
  13. Article
  14. Observational
  15. Review
  16. Review
  17. CLINICAL MANAGEMENT OF LOCALIZED BCG ADVERSE EVENTS IN CHILDREN.Revista do Instituto de Medicina Tropical de Sao Paulo · 2016
    Article
  18. Reply to Thysen et al.The Journal of infectious diseases · 2015
    Article
  19. Targeting 90-90-90--don't leave children and adolescents behind.Journal of the International AIDS Society · 2015
    Article
  20. 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

13 authors at 7 institutions in 2 countries.

H RabieChildren's Infectious Diseases Clinical Research Unit, Department of Paediatrics & Child Health, Stellenbosch University and Tygerberg Children's Hospital, Cape Town, South Africa. hrabie@sun.ac.za
A Violari
T Duong
S A Madhi
D Josipovic
S Innes
E Dobbels
E Lazarus
R Panchia
A G Babiker
D M Gibb
M F Cotton
CHER team
Stellenbosch University · ZAUniversity of the Witwatersrand · ZAMedical Research Council · GBLondon School of Hygiene & Tropical Medicine · GBNational Research Foundation · ZAPerinatal HIV Research Unit · ZATygerberg Children’s Hospital · ZA

Funding

The effect of ART on rates and transmission of TBU19AI053217 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI MCINTYRE, JAMES ALASDAIR · 2002 to 2011
$44.9M
Medical Research Council G0700837Medical Research Council MC_U122886353NIAID NIH HHS U19 AI053217NIAID NIH HHS U19 AI53217
6 · The paper itself

Abstract

settingTwo centres in Soweto and Cape Town, South Africa.

objectiveTo assess the effects of timing of initiation of antiretroviral treatment (ART) and other factors on the risk of bacille Calmette-Guérin (BCG) related regional adenitis due to immune reconstitution inflammatory syndrome (BCG-IRIS) in human immunodeficiency virus (HIV) infected infants.

designHIV-infected infants aged 6-12 weeks with CD4 count ≥25% enrolled in the Children with HIV Early Antiretroviral Therapy (CHER) Trial received early (before 12 weeks) or deferred (after immunological or clinical progression) ART; infants with CD4 count <25% all received early ART. All received BCG vaccination after birth. Reactogenicity to BCG was assessed prospectively during routine study follow-up.

resultsOf 369 infants, 32 (8.7%) developed BCG-IRIS within 6 months of starting ART, 28 (88%) within 2 months after ART initiation. Of the 32 cases, 30 (93.8%) had HIV-1 RNA > 750 000 copies/ml at initiation. Incidence of BCG-IRIS was 10.9 and 54.3 per 100 person-years (py) among infants with CD4 count ≥25% at enrolment receiving early (at median age 7.4 weeks) vs. deferred (23.2 weeks) ART, respectively (HR 0.24, 95%CI 0.11-0.53, P < 0.001). Infants with CD4 count <25% receiving early ART had intermediate incidence (41.7/100 py). Low CD4 counts and high HIV-1 RNA at initiation were the strongest independent risk factors for BCG-IRIS.

conclusionsEarly ART initiation before immunological and/or clinical progression substantially reduces the risk of BCG-IRIS regional adenitis.

Indexed as

Anti-HIV AgentsBCG VaccineCD4 Lymphocyte CountFemaleFollow-Up StudiesHIV-1HIV InfectionsHumansImmune Reconstitution Inflammatory SyndromeInfantLymphadenitisMaleProspective StudiesRisk FactorsRNA, ViralSouth AfricaAnti-HIV AgentsBCG VaccineRNA, ViralBCGimmune reconstitution inflammatory syndromepaediatric HIV

Identifiers

PMID21943845
PMCPMC3183835
OpenAlexW2154939162

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.