Pharmacokinetic Research in Pediatric HIV/TB Co Infection (R01) | Apply Online

Opportunity Summary:

The Pharmacokinetic Research in Pediatric HIV/TB Co-Infection (R01) funding opportunity (RFA-HD-09-015) is an NIH grant announcement led by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) with participation from the National Institute of Mental Health (NIMH). Its main goal is to close a major evidence gap in how tuberculosis (TB) drugs behave in the bodies of children who are also living with HIV, and how TB drugs interact with antiretroviral therapy (ART). In practical terms, the FOA is looking for R01 research projects that measure and analyze pharmacokinetics (how drugs are absorbed, distributed, metabolized, and eliminated) for anti-TB medications in HIV-infected children, and that characterize pharmacokinetic drug-drug interactions between anti-TB regimens and anti-HIV medications. The announcement emphasizes that pediatric data lag far behind adult data because diagnosing and managing TB in children is difficult, and because co-treatment with HIV introduces extra complexity and risk. The urgency is framed around the need for better, child-specific evidence to support safe and effective treatment decisions.

A central scientific theme is dosing: the FOA explicitly supports studies designed to define appropriate dosing of anti-TB agents in HIV-infected children rather than relying on adult-derived assumptions. Applicants are also encouraged to generate early or preliminary evidence about whether specific pharmacokinetic parameters (for example, drug exposure levels over time) are linked to meaningful clinical outcomes in pediatric HIV/TB co-infection, such as treatment response or failure. Another highlighted priority is improving management when TB affects the central nervous system. The FOA calls out the evaluation of central nervous system (CNS) penetration of anti-TB agents in the context of antiretroviral therapy, reflecting the clinical reality that TB meningitis and other CNS forms of TB are especially dangerous in children and may require adequate drug levels in the CNS to improve outcomes.

From a grants and administrative perspective, this opportunity uses the NIH Research Project Grant (R01) mechanism, meaning it is intended for full-scale, hypothesis-driven projects with sufficient scope to produce robust pharmacokinetic and interaction data. It was issued in parallel with a companion announcement of the same scientific scope using the R21 mechanism (RFA-HD-09-016), which generally supports more exploratory or early-stage work. For this R01 FOA, the NIH projected support in FY 2010 totaling about $1.5 million in total costs (NICHD intending to commit $1.15 million and NIMH $350,000), with an anticipated one to three awards depending on the quality of applications and the availability of funds.

Eligibility is broad and includes many common applicant types across academia, government, and the nonprofit and for-profit sectors. Eligible applicants include public and private institutions of higher education, public and state-controlled universities, nonprofits with or without 501(c)(3) status (with the usual exclusions noted), for-profit organizations other than small businesses, and small businesses. Government entities at multiple levels (state, county, city or township, special districts), as well as public housing authorities/Indian housing authorities, are listed as eligible. The FOA also explicitly includes a range of mission-focused and underserved-serving institutions and organizations, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations. Importantly, it also allows non-U.S. entities (foreign organizations), regional organizations, and U.S. territories or possessions, signaling interest in research that may be conducted in settings where pediatric HIV/TB co-infection is most prevalent.

Key logistics included a posted date of March 3, 2010, with an application closing date of August 24, 2010, and an archive date of September 24, 2010. The opportunity is categorized as discretionary funding, uses the grant funding instrument, and falls under health-related assistance programs (including CFDA 93.242 for Mental Health Research Grants and 93.865 for Child Health and Human Development Extramural Research). No cost sharing or matching was required, which is typical for many NIH research grants. The full announcement was hosted through the NIH grants guide, with support contacts routed through the NIH Office of Extramural Research (OER) for access or linking issues.

Overall, the FOA is aimed at generating the kind of pediatric-specific pharmacokinetic and interaction evidence that can directly improve real-world clinical care for children facing the combined burden of HIV and TB, including severe forms like CNS TB. The intended payoff is clearer dosing guidance, better co-treatment strategies with ART, and a stronger scientific basis for optimizing outcomes in a population that has historically been under-studied compared with adults.

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