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

Oleh:

Zar, Heather J. ; Cotton, Mark F ; Strauss, Stanzi ; Karpakis, Janine ; Hussey, Gregory ; Schaaf, Simon

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: British Medical Journal (keterangan: ada di Proquest) vol. 334 no. 7585 (Jan. 2007), page 136.

Ketersediaan

Perpustakaan FK Nomor Panggil: B16.K.2007.04 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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ABSTRACT Objectives To investigate the impact of isoniazid prophylaxis on mortality and incidence of tuberculosis in children with HIV. Design Two centre prospective double blind placebo controlled trial. Participants Children aged 2:8 weeks with HIV. Interventions Isoniazid or placebo given with co¬trimoxazole either daily or three times a week. Setting Two tertiary healthcare centres hi South Africa. Main outcome measures Mortality, incidence of tuberculosis, and adverse events. Results Data 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. Conclusions Prophylaxis 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 registration Clinical Trials NCT00330304. INTRODUCTION Tuberculosis and HIV are dual pandemics in children in sub-Saharan Africa. Tuberculosis accelerates the course of HI V, increasing morbidity, mortality, and the frequency of opportunistic infections,l-4 and is respon¬sible for a major proportion of mortality.5 Prevention of tuberculosis in children with HIV through prophy¬laxis with isoniazid may be effective in reducing mortal¬ity in areas with a high prevalence of tuberculosis. In studies of adults with HIV prophylaxis with isoniazid significantly reduced the incidence of tuberculosis.6-8 The effect of such prophylaxis in children is unknown. We investigated the effect of isoniazid prophylaxis on mortality in children with HIV living in an area with high tuberculosis prevalence. METHODS We carried out a prospective double blind placebo controlled trial of isoniazid versus placebo given with co-trimoxazole either daily or three times a week in children with HIV in two centres in Cape Town, South Africa. The study started in January 2003; the placebo arm of the study was ended on 17 May 2004 on the recommendation of the data safety monitoring board

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