Evidence map›Paper›PMID 17085459›Full record

Trial reportBMJ (Clinical research ed.)2007

Effect of isoniazid prophylaxis on mortality and incidence of tuberculosis in children with HIV: randomised controlled trial.

Heather J Zar, Mark F Cotton, Stanzi Strauss, Janine Karpakis, Gregory Hussey, H Simon Schaaf, Helena Rabie, Carl J Lombard

4 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ (Clinical research ed.), 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 94 papers, 21 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed, 21 pooled it
8.4field-weighted citation impact, top 2% 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.

NCT00330304 phase3completednot on this map

Long Term Study of 2 Isoniazid (INH) Prophylactic Regimens With Concomitant Cotrimoxazole (CTX) in HIV-infected Children - Impact on Morbidity, Mortality, Bacterial Resistance and Incidence of Tuberculosis

TypeinterventionalSponsorUniversity of Cape TownRan2003 to 2011Enrolled450ConditionsTuberculosisArmsIsoniazid, Cotrimoxazole, isoniazid, placebo
NCT01494038 phase4completednot on this mapstarted 2014, after this paper: background citation

A Phase IV Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Safety of Immediate (Antepartum-Initiated) Versus Deferred (Postpartum-Initiated) Isoniazid Preventive Therapy Among HIV-Infected Women in High Tuberculosis (TB) Incidence Settings

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2014 to 2017Enrolled956ConditionsHIV Infections, TuberculosisArmsIsoniazid (INH), Placebo for isoniazid (INH)
NCT02348177 phase4completednot on this mapstarted 2013, after this paper: background citation

A Pharmacokinetics Study Comparing Lopinavir Plasma Exposure When Given as Lopinavir/Ritonavir (1:1) in the Presence of Rifampicin and Lopinavir/Ritonavir (4:1) Without Rifampicin in HIV and TB Co-infected Children in South Africa.

TypeinterventionalSponsorDrugs for Neglected DiseasesRan2013 to 2016Enrolled96ConditionsAcquired Immunodeficiency Syndrome, TuberculosisArmslopinavir with ritonavir in 1:1 ratio, Lopinavir/ritonavir 4:1
NCT02613169 phase2completednot on this mapstarted 2016, after this paper: background citation

Preventing Mycobacterium Tuberculosis Infection in HIV-Exposed Infants

TypeinterventionalSponsorUniversity of WashingtonRan2016 to 2020Enrolled300ConditionsTuberculosisArmsIsoniazid
3 · Its place in the literature

Who cites it

94 citing papers in PubMed, 21 syntheses or guidelines pooled it, 254 citations in OpenAlex.

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  9. Guidelines for the Treatment of Latent Tuberculosis Infection: Recommendations from the National Tuberculosis Controllers Association and CDC, 2020.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2020
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  12. Isoniazid for preventing tuberculosis in HIV-infected children.The Cochrane database of systematic reviews · 2017
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  20. Guideline

34 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

Heather J ZarSchool of Child and Adolescent Health, Red Cross Children's Hospital, University of Cape Town, South Africa. hzar@ich.uct.ac.za
Mark F Cotton
Stanzi Strauss
Janine Karpakis
Gregory Hussey
H Simon Schaaf
Helena Rabie
Carl J Lombard
South African Medical Research Council · ZAStellenbosch University · ZARed Cross War Memorial Children's Hospital · ZAUniversity of Cape Town · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo investigate the impact of isoniazid prophylaxis on mortality and incidence of tuberculosis in children with HIV.

designTwo centre prospective double blind placebo controlled trial.

participantsChildren aged > or =8 weeks with HIV.

interventionsIsoniazid or placebo given with co-trimoxazole either daily or three times a week.

settingTwo tertiary healthcare centres in South Africa.

main outcome measuresMortality, incidence of tuberculosis, and adverse events.

resultsData on 263 children (median age 24.7 months) were available when the data safety monitoring board recommended discontinuing the placebo arm; 132 (50%) were taking isoniazid. Median follow-up was 5.7 (interquartile range 2.0-9.7) months. Mortality was lower in the isoniazid group than in the placebo group (11 (8%) v 21 (16%), hazard ratio 0.46, 95% confidence interval 0.22 to 0.95, P=0.015) by intention to treat analysis. The benefit applied across Centers for Disease Control clinical categories and in all ages. The reduction in mortality was similar in children on three times a week or daily isoniazid. The incidence of tuberculosis was lower in the isoniazid group (5 cases, 3.8%) than in the placebo group (13 cases, 9.9%) (hazard ratio 0.28, 0.10 to 0.78, P=0.005). All cases of tuberculosis confirmed by culture were in children in the placebo group.

conclusionsProphylaxis with isoniazid has an early survival benefit and reduces incidence of tuberculosis in children with HIV. Prophylaxis may offer an effective public health intervention to reduce mortality in such children in settings with a high prevalence of tuberculosis.

trial registrationClinical Trials NCT00330304.

Indexed as

Africa South of the SaharaAnti-Retroviral AgentsAntitubercular AgentsChildChild, PreschoolDeveloping CountriesDouble-Blind MethodHealth Services AccessibilityHIV InfectionsHumansIncidenceInfantInfant, NewbornIsoniazidTuberculosis, PulmonaryAnti-Retroviral AgentsAntitubercular AgentsIsoniazid

Identifiers

PMID17085459
PMCPMC1779846
OpenAlexW2155753953

What OpenQuestion 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 OpenQuestion graph.