Opportunities for HIV Cure Strategies at the Time of ART Initiation (R21 Clinical Trial Not Allowed)

The National Institutes of Health (NIH), through the National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), invites applications for the “Opportunities for HIV Cure Strategies at the Time of ART Initiation” under the R21 exploratory/developmental research grant mechanism. This funding opportunity is designed to support basic and pre-clinical research into HIV cure strategies that are administered at the initiation of combination antiretroviral therapy (cART) or during its reinitiation following an analytical treatment interruption (ATI). The overarching goal is to discover methods capable of achieving a sustained treatment-free remission for individuals living with HIV. The grant focuses on interventions aimed at reducing the HIV reservoir and enhancing HIV-specific immune responses. Emphasis is placed on early-stage research that can illuminate decay dynamics of HIV-infected cells and test novel therapeutic strategies in animal models or using human clinical samples. Eligible strategies must be experimental and not yet FDA-approved for HIV indications, though early interventions without cART that have shown antiviral activity in prior studies are acceptable. Basic research should target mechanisms influencing reservoir size and viral control, while targeted interventions may include strategies to eliminate infected cells or boost immune responses. Eligible applicants include a broad range of entities such as higher education institutions, nonprofits, for-profit organizations, and various governmental entities. Both domestic and foreign institutions, including those with non-U.S. components, are eligible. Applications must conform to the NIH standard application instructions, and only projects without clinical trials will be accepted. The funding opportunity does not require cost-sharing or a letter of intent. The funding instrument is a grant with a project period of up to two years and a combined budget not exceeding $275,000 in direct costs, with a maximum of $200,000 in any single year. Applications must be submitted electronically via NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution. Reviewers will evaluate applications based on significance, innovation, investigators, approach, and environment. The evaluation will emphasize the potential of the research to contribute to the goal of HIV remission without continuous therapy. Applications are reviewed through a structured schedule with multiple annual due dates for AIDS-related applications: January 7, May 7, and September 7. Awards follow approximately six to nine months after each due date. The final application submission date is May 24, 2025, per a revised expiration timeline. Scientific and administrative contacts are available for each participating NIH institute, and applicants are encouraged to consult these officials with specific questions. The NIH strongly encourages collaboration with industry partners and interdisciplinary team science, particularly involving early-stage investigators.