Trial reportThe New England journal of medicine2011
Primary isoniazid prophylaxis against tuberculosis in HIV-exposed children.
Trial report in The New England journal of medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 81 papers, 11 of them syntheses that pooled 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.
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.
A Randomized, Double Blind, Placebo Controlled Trial to Determine the Efficacy of Isoniazid (INH) in Preventing Tuberculosis Disease and Latent Tuberculosis Infection Among Infants With Perinatal Exposure to HIV
Preventing Mycobacterium Tuberculosis Infection in HIV-Exposed Infants
Who cites it
81 citing papers in PubMed, 11 syntheses or guidelines pooled it, 161 citations in OpenAlex.
- Tuberculosis in children who are HIV-exposed uninfected.AIDS (London, England) · 2026Pooled it
- Efficacy and safety of different regimens in the treatment of patients with latent tuberculosis infection: a systematic review and network meta-analysis of randomized controlled trials.Archives of public health = Archives belges de sante publique · 2023Pooled it
- Tuberculosis preventive therapy for people living with HIV: A systematic review and network meta-analysis.PLoS medicine · 2021Pooled it
- 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 · 2020Pooled it
- Isoniazid for the Prevention of Tuberculosis in HIV-Infected Children: A Systematic Review and Meta-Analysis.The Pediatric infectious disease journal · 2018Pooled it
- Role of HIV exposure and infection in relation to neonatal GBS disease and rectovaginal GBS carriage: a systematic review and meta-analysis.Scientific reports · 2017Pooled it
- Isoniazid for preventing tuberculosis in HIV-infected children.The Cochrane database of systematic reviews · 2017Pooled it
- Antibiotics for preventing lower respiratory tract infections in high-risk children aged 12 years and under.The Cochrane database of systematic reviews · 2015Pooled it
- Efficacy of isoniazid prophylactic therapy in prevention of tuberculosis in children: a meta-analysis.BMC infectious diseases · 2014Pooled it
- Rifamycins (rifampicin, rifabutin and rifapentine) compared to isoniazid for preventing tuberculosis in HIV-negative people at risk of active TB.The Cochrane database of systematic reviews · 2013Pooled it
- Clinical practice guideline for the evaluation, treatment, and follow-up of children in contact with patients with pulmonary tuberculosis in Colombia.Colombia medica (Cali, Colombia)Guideline
- Predictors of TB disease in HIV-exposed children from Southern Africa.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2023Trial
- A CD4+ TNF+ monofunctional memory T-cell response to BCG vaccination is associated with Mycobacterium tuberculosis infection in infants exposed to HIV.EBioMedicine · 2022Trial
- A Randomized Controlled Trial of Isoniazid to Prevent Mycobacterium tuberculosis Infection in Kenyan Human Immunodeficiency Virus-Exposed Uninfected Infants.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Trial
- Evaluation of a serum-based antigen test for tuberculosis in HIV-exposed infants: a diagnostic accuracy study.BMC medicine · 2021Trial
- High Incidence of Tuberculosis Infection in HIV-exposed Children Exiting an Isoniazid Preventive Therapy Trial.The Pediatric infectious disease journal · 2018Trial
- Safety and Immunogenicity of Newborn MVA85A Vaccination and Selective, Delayed Bacille Calmette-Guerin for Infants of Human Immunodeficiency Virus-Infected Mothers: A Phase 2 Randomized, Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018Trial
- BCG vaccination induces HIV target cell activation in HIV-exposed infants in a randomized trial.JCI insight · 2017Trial
- Use of antiretrovirals in HIV-infected children in a tuberculosis prevention trial: IMPAACT P1041.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2017Trial
- Source case identification in HIV-exposed infants and tuberculosis diagnosis in an isoniazid prevention study.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2016Trial
21 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
10 authors at 9 institutions in 2 countries.
Funding
Abstract
backgroundThe dual epidemic of human immunodeficiency virus (HIV) and tuberculosis is a major cause of sickness and death in sub-Saharan Africa. We conducted a double-blind, randomized, placebo-controlled trial of preexposure isoniazid prophylaxis against tuberculosis in HIV-infected children and uninfected children exposed to HIV during the perinatal period.
methodsWe randomly assigned 548 HIV-infected and 804 HIV-uninfected infants (91 to 120 days of age) to isoniazid (10 to 20 mg per kilogram of body weight per day) or matching placebo for 96 weeks. All patients received bacille Calmette-Guérin (BCG) vaccination against tuberculosis within 30 days after birth. HIV-infected children had access to antiretroviral therapy. The primary outcome measures were tuberculosis disease and death in HIV-infected children and latent tuberculosis infection, tuberculosis disease, and death in HIV-uninfected children within 96 to 108 weeks after randomization.
resultsAntiretroviral therapy was initiated in 98.9% of HIV-infected children during the study. Among HIV-infected children, protocol-defined tuberculosis or death occurred in 52 children (19.0%) in the isoniazid group and 53 (19.3%) in the placebo group (P=0.93). Among HIV-uninfected children, there was no significant difference in the combined incidence of tuberculosis infection, tuberculosis disease, or death between the isoniazid group (39 children, 10%) and the placebo group (45 children, 11%; P=0.44). The rate of tuberculosis was 121 cases per 1000 child-years (95% confidence interval [CI], 95 to 153) among HIV-infected children as compared with 41 per 1000 child-years (95% CI, 31 to 52) among HIV-uninfected children. There were no significant differences in clinical or severe laboratory toxic effects between treatment groups.
conclusionsPrimary isoniazid prophylaxis did not improve tuberculosis-disease-free survival among HIV-infected children or tuberculosis-infection-free survival among HIV-uninfected children immunized with BCG vaccine. Despite access to antiretroviral therapy, the burden of tuberculosis remained high among HIV-infected children. (Funded by the National Institutes of Health and Secure the Future; ClinicalTrials.gov number, NCT00080119.).
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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.