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


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.

SUBMITTER: Zeldow B 

PROVIDER: S-EPMC5606242 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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

Zeldow B B   Kim S S   McSherry G G   Cotton M F MF   Jean-Philippe P P   Violari A A   Bobat R R   Nachman S S   Mofenson L M LM   Madhi S A SA   Mitchell C C  

The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease 20170101 1


<h4>Setting</h4>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).<h4>Objective</h4>To estimate TB incidence and mortality and the effect of ART.<h4>Design</h4>Children were pre-screened to exclude TB disease and exposure, actively screened 3-monthly for TB exposure and symptoms, and provided post-expos  ...[more]

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