Trial reportPloS one2012
Efficacy of a six-month versus a 36-month regimen for prevention of tuberculosis in HIV-infected persons in India: a randomized clinical trial.
Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00351702 (Evaluation of Two Different Preventive Therapy Regimens for Tuberculosis in HIV Infected Persons), which is not on this map. Cited by 23 papers, 4 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.
Evaluation of Two Different Preventive Therapy Regimens for Tuberculosis in HIV Infected Persons
Who cites it
23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 52 citations in OpenAlex.
- 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
- Continuous isoniazid for the treatment of latent tuberculosis infection in people living with HIV.AIDS (London, England) · 2016Pooled it
- A mid-level health manager intervention to promote uptake of isoniazid preventive therapy among people with HIV in Uganda: a cluster randomised trial.The lancet. HIV · 2022Trial
- Isoniazid plus antiretroviral therapy to prevent tuberculosis: a randomised double-blind, placebo-controlled trial.Lancet (London, England) · 2014Trial
- Article
- Review
- Breakthrough TB among people living with HIV on TB preventive therapy.Public health action · 2022Article
- Pulmonary tuberculosis screening in anti-retroviral treated adults living with HIV in Kenya.BMC infectious diseases · 2021Article
- Incidence of tuberculosis among HIV infected individuals on long term antiretroviral therapy in private healthcare sector in Pune, Western India.BMC infectious diseases · 2019Article
- Crusade for TB:The Indian journal of medical research · 2019Article
- TB preventive therapy for people living with HIV: key considerations for scale-up in resource-limited settings.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2018Article
- Addressing knowledge gaps and prevention for tuberculosis-infected Indian adults: a vital part of elimination.BMC infectious diseases · 2018Article
- IPT during HIV treatment in Myanmar: high rates of coverage, completion and drug adherence.Public health action · 2018Article
- Tuberculosis preventive treatment: the next chapter of tuberculosis elimination in India.BMJ global health · 2018Article
- Tuberculosis Associated with HIV Infection.Microbiology spectrum · 2017Review
- Current trends and intricacies in the management of HIV-associated pulmonary tuberculosis.AIDS research and therapy · 2016Review
- Debunking the myths perpetuating low implementation of isoniazid preventive therapy amongst human immunodeficiency virus-infected persons.World journal of virology · 2015Review
- Use of isoniazid preventive therapy for tuberculosis prophylaxis among people living with HIV/AIDS: a review of the literature.Journal of acquired immune deficiency syndromes (1999) · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundThe optimal duration of preventive therapy for tuberculosis (TB) among HIV-infected persons in TB-endemic countries is unknown.
methodsAn open-label randomized clinical trial was performed and analyzed for equivalence. Seven hundred and twelve HIV-infected, ART-naïve patients without active TB were randomized to receive either ethambutol 800 mg and isoniazid 300 mg daily for six-months (6EH) or isoniazid 300 mg daily for 36-months (36H). Drugs were dispensed fortnightly and adherence checked by home visits. Patients had chest radiograph, sputum smear and culture performed every six months, in addition to investigations if they developed symptoms. The primary endpoint was incident TB while secondary endpoints were all-cause mortality and adverse events. Survival analysis was performed on the modified intent to treat population (m-ITT) and rates compared.
findingsTuberculosis developed in 22 (6.4%) of 344 subjects in the 6EH arm and 13 (3.8%) of 339 subjects in the 36H arm with incidence rates of 2.4/100 py (95%CI- 1.4-3.5) and 1.6/100 py (95% CI-0.8-3.0) with an adjusted rate ratio (aIRR) of 1.6 (0.8-3.2). Among TST-positive subjects, the aIRR of 6EH was 1.7 (0.6-4.3) compared to 36H, p = 0.8. All-cause mortality and toxicity were similar in the two arms. Among 15 patients with confirmed TB, 4 isolates were resistant to isoniazid and 2 were multidrug-resistant.
interpretationBoth regimens were similarly effective in preventing TB, when compared to historical incidence rates. However, there was a trend to lower TB incidence with 36H. There was no increase in isoniazid resistance compared to the expected rate in HIV-infected patients. The trial is registered at ClinicalTrials.gov, NCT00351702.
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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.