Pharmacokinetic Research in Pediatric HIV/TB Co-Infection (R01)

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Purpose. This Funding Opportunity Announcement (FOA), issued by the National Institute of Child Health and Human Development (NICHD) and the National Institute of Mental Health (NIMH), encourages Research Project Grant (R01) applications from institutions/organizations that propose to evaluate the pharmacokinetics of anti-tuberculosis (anti-TB) drugs and pharmacokinetic drug interactions between anti-TB drugs and anti-HIV medications, and to potentially provide preliminary data regarding the effect of such pharmacokinetic parameters on the outcome of treatment in children with HIV/TB co-infection.Pediatric research in these areas lags far behind that in adults due to the many challenges surrounding the diagnosis and management of TB disease in children. Research related to the treatment of TB in the context of pediatric HIV/TB co-infection is urgently needed.This FOA will support grants to define appropriate dosing of anti-TB agents in HIV-infected children and that will generate knowledge regarding the optimization of management of TB/HIV co-infection in children, including the management of central nervous system (CNS) involvement with TB through the evaluation of CNS penetration of anti-TB agents in the context of antiretroviral therapy. Mechanism of Support. This FOA will utilize the NIH Research Project Grant (R01) grant mechanism and is issued in parallel with an FOA of identical scientific scope, RFA HD-09-016 that solicits applications under the R21 grant mechanism. Funds Available and Anticipated Number of Awards. The NICHD intends to commit $1.15 million (total costs), and NIMH intends to commit $350,000 (total costs) in FY 2010 to support one to three meritorious applications. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

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