Cellular Models of HIV Pathogenesis within NIDDK Mission Areas (R01 Clinical Trial Not Allowed) | RFA DK 25 021

Opportunity Information: Apply for RFA DK 25 021

Cellular Models of HIV Pathogenesis within NIDDK Mission Areas (R01 Clinical Trial Not Allowed) is an NIH research grant opportunity (Funding Opportunity Number RFA-DK-25-021) that supports projects aimed at building, refining, and applying advanced human-relevant cellular systems to better understand how HIV interacts with tissues and biological processes that fall under the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The central emphasis is on physiologically realistic models that capture key features of normal human biology, especially next-generation platforms such as microphysiological systems (often called "organ-on-a-chip" approaches), organoids, and other three-dimensional cellular or tissue models. The intent is to move beyond simplified culture systems and use models that can more faithfully reproduce tissue architecture, multicellular interactions, and functional biology relevant to HIV persistence and HIV-associated disease processes in NIDDK-related organ systems.

The scientific goals focus on HIV pathogenesis in contexts that matter to NIDDK, with projects expected to explore how HIV establishes and maintains persistence, how latency is created and sustained, what triggers reactivation, and what mechanisms might enable eradication or durable control. In addition to direct viral biology, the NOFO highlights interest in pathological processes that contribute to co-occurring conditions, meaning applicants can propose studies that link HIV infection or HIV-related inflammation and immune dysfunction to downstream tissue injury or chronic complications within NIDDK areas. In practice, this can include mechanistic work on how HIV or HIV-driven immune signaling affects metabolic pathways, gut and liver biology, pancreatic function, kidney tissue integrity, or other relevant physiological processes, as long as the proposal remains anchored in strong cellular modeling and clear relevance to NIDDK mission priorities.

This is an R01 mechanism, which typically supports substantial, hypothesis-driven or technology-enabling research programs, and it is explicitly "Clinical Trial Not Allowed," meaning the funded work must be non-clinical-trial research rather than interventional studies in human participants. The funding instrument type is a grant, categorized under discretionary funding, and the activity category is listed under food and nutrition and health. The opportunity references CFDA numbers 93.313 and 93.847, aligning it with NIH/NIDDK-related assistance listings. The posted award ceiling is $500,000, indicating an upper bound on the funding level anticipated per award under this announcement (with final budgets generally depending on NIH policies, project scope, and negotiated needs).

Eligibility is broad and includes many organization types across the public, private, nonprofit, and academic sectors. Eligible applicants include state, county, and city governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations that are not federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education); for-profit organizations (other than small businesses) as well as small businesses; and other categories. The NOFO also explicitly calls out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations). This wide eligibility is meant to encourage participation from diverse institutions and communities with relevant expertise in HIV biology, tissue modeling, and NIDDK-related disease research.

Key dates and administrative details include a creation date of September 16, 2024, and an original application closing date of March 20, 2025. The sponsoring agency is the National Institutes of Health. While the posting lists "ExpectedAwards" without a specific number in the provided text, applicants should generally interpret that as meaning NIH anticipates making one or more awards depending on the quality of applications and availability of funds.

Overall, this NOFO is designed for researchers who can credibly recreate aspects of human tissue physiology in vitro and use those systems to answer hard questions about HIV persistence and HIV-driven pathology in organ systems relevant to diabetes, digestive diseases, nutrition, and kidney disease. Competitive applications will typically present a strong rationale for why the chosen cellular model is necessary and superior for the specific biological questions posed, a clear plan to validate that the model reflects meaningful features of human physiology, and well-defined mechanistic endpoints tied to viral persistence, latency, reactivation, eradication strategies, or the biology of HIV-associated comorbidities within NIDDK mission areas.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Cellular Models of HIV Pathogenesis within NIDDK Mission Areas (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.313, 93.847.
• This funding opportunity was created on 2024-09-16.
• Applicants must submit their applications by 2025-03-20. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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