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Clinical Trial
. 2017 Jan 1;21(1):38-45.
doi: 10.5588/ijtld.16.0149.

Use of antiretrovirals in HIV-infected children in a tuberculosis prevention trial: IMPAACT P1041

B Zeldow  1 , S Kim  2 , G McSherry  3 , M F Cotton  4 , P Jean-Philippe  5 , A Violari  6 , R Bobat  7 , S Nachman  8 , L M Mofenson  9 , S A Madhi  10 , C Mitchell  11
Affiliations
Clinical Trial

Use of antiretrovirals in HIV-infected children in a tuberculosis prevention trial: IMPAACT P1041

B Zeldow et al. Int J Tuberc Lung Dis. .

Abstract

Setting: International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) P1041, a tuberculosis (TB) prevention trial conducted among children enrolled from 2004 to 2008 during South Africa's roll-out of combination antiretroviral therapy (ART).

Objective: To estimate TB incidence and mortality and the effect of ART.

Design: Children were pre-screened to exclude TB disease and exposure, actively screened 3-monthly for TB exposure and symptoms, and provided post-exposure isoniazid prophylaxis therapy (IPT). TB diagnoses were definite, probable, or possible, and mortality all-cause. Testing was at the 5% significance level.

Results: In 539 children (aged 3-4 months) followed up for a median of 74 weeks (interquartile range [IQR] 48-116), incidence/100 person-years (py) was 10.67 (95%CI 8.47-13.26) for any TB and 2.89 (95%CI 1.85-4.31) for definite/probable TB. Any TB incidence was respectively 9.39, 13.59, and 9.83/100 py before, <180 days after, and 180 days after ART initiation. Adjusted analysis showed a non-significant increase in any TB (HR 1.32, 95%CI 0.71-2.52, P = 0.38) and a significant reduction in mortality (HR 0.39, 95%CI 0.17-0.82, P = 0.017) following ART initiation.

Conclusions: ART reduced mortality but not TB incidence in human immunodeficiency virus (HIV) infected children in IMPAACT P1041, possibly attributable to active screening for TB exposure and symptoms with post-exposure IPT. Research into this as a strategy for TB prevention in high HIV-TB burden settings may be warranted.

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Conflict of interest statement

Conflicts of interest: Drs Violari and Cotton report receiving lecture fees from Abbott Laboratories, Dr Madhi reports receiving fees from Pfizer, GSK, Sanofi Pasteur and Novartis for participation in expert-boards and/or for supporting PhD students, and Dr Mitchell reports receiving lecture fees from MedImmune, GSK, and Novartis Vaccines. No other potential conflict of interest relevant to this article was reported.

Figures

Figure 1
Figure 1
Disposition of Study Participants
See this image and copyright information in PMC

References

    1. WHO. Global Tuberculosis Report 2015. 2015 http://apps.who.int/iris/bitstream/10665/191102/1/9789241565059_eng.pdf?.... Accessed December 22, 2015.
    1. Perez-Velez CM, Marais BJ. Tuberculosis in children. N Engl J Med. 2012;367(4):348–361. - PubMed
    1. Swaminathan S, Rekha B. Pediatric tuberculosis: global overview and challenges. Clin Infect Dis. 2010;50(Suppl 3):S184–194. - PubMed
    1. Hesseling AC, Cotton MF, Jennings T, et al. High incidence of tuberculosis among HIV-infected infants: evidence from a South African population-based study highlights the need for improved tuberculosis control strategies. Clin Infect Dis. 2009;48(1):108–114. - PubMed
    1. Dangor Z, Izu A, Hillier K, et al. Impact of the Antiretroviral Treatment Program on the Burden of Hospitalization for Culture-confirmed Tuberculosis in South African Children: A Time-series Analysis. Pediatr Infect Dis J. 2013;32(9):972–977. - PubMed

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