Elucidating Immunometabolic Responses to HIV Infection that Increase TB or HBV Risk (R01 Clinical Trial Not Allowed)

The National Institutes of Health (NIH), through its National Institute of Allergy and Infectious Diseases (NIAID), issued a funding opportunity titled "Elucidating Immunometabolic Responses to HIV Infection that Increase TB or HBV Risk" under activity code R01. This grant is focused on supporting research that investigates the long-term immunometabolic alterations caused by HIV infection, particularly in individuals whose viral load is suppressed through combination antiretroviral therapy (cART). The overarching objective is to understand how these metabolic changes influence susceptibility to secondary infections like tuberculosis (TB) and hepatitis B virus (HBV), which remain major causes of morbidity and mortality among people living with HIV (PLWH). The funder, NIAID, is a component of the U.S. Department of Health and Human Services and plays a central role in the national and global research strategy against infectious, immunologic, and allergic diseases. NIAID supports both basic and applied research aimed at understanding, preventing, and treating these conditions. This funding opportunity underscores NIAID’s commitment to advancing knowledge in immunometabolism—a field that examines the intersection between immune response and metabolic regulation. Recent advances in immunometabolism and systems biology offer the potential for significant progress in discovering biomarkers and therapeutic targets for co-infections in HIV-positive populations. The scope of this opportunity covers hypothesis-driven basic, preclinical, and translational laboratory research. Specific areas of interest include how HIV-induced changes to immunometabolism affect immune regulation and response to treatment during co-infection with TB or HBV. Proposed projects may include investigations into cell-cell interactions, multi-omic immune profiling, and the identification of therapeutic or diagnostic biomarkers. The NOFO encourages the formation of interdisciplinary teams, incorporation of machine learning or AI techniques, and utilization of existing clinical samples and model systems. Applications must not propose clinical trials. The grant supports projects of up to five years in duration. While the application budget is not capped, it must be commensurate with the project’s scope and needs. The opportunity is open to a wide range of domestic and foreign applicants, including institutions of higher education, non-profits, tribal governments, small and for-profit businesses, and international entities. All applicants are required to complete standard federal registrations such as SAM.gov, eRA Commons, and Grants.gov. The original open date for this NOFO was April 7, 2025, with recurring AIDS-related application deadlines on May 7, September 7, and January 7 of each year through January 2028. However, the opportunity was officially expired early on February 18, 2026, per Notice NOT-AI-26-010. Notwithstanding this expiration, applications may be accepted for a limited period on a case-by-case basis under NIH’s late submission policy, especially for AIDS-designated applications. The earliest possible project start dates range from December 2025 to July 2028, depending on the cycle. Applicants are instructed to follow the standard NIH application process using platforms such as ASSIST, institutional system-to-system (S2S) solutions, or Grants.gov Workspace. Comprehensive guidance on formatting, required forms, data sharing, biosketches, letters of support, and human subjects protocols are provided in the NIH Application Guide. Notably, all applications must include a Data Management and Sharing Plan in line with NIH policy. Evaluation of applications will consider significance, innovation, rigor, feasibility, investigator expertise, and the scientific environment. Funding decisions will be based on peer review results, availability of funds, and alignment with program priorities. Direct pre-award costs are allowable, and selected recipients will receive formal Notices of Award from NIAID.