Opportunities for HIV Cure Strategies at the Time of ART Initiation (R01 Clinical Trial Not Allowed)

The National Institutes of Health (NIH), specifically through the National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Institute of Mental Health (NIMH), is soliciting applications under the "Opportunities for HIV Cure Strategies at the Time of ART Initiation (R01 Clinical Trial Not Allowed)" funding opportunity. This grant program seeks to identify and support HIV cure strategies administered at the start of combination antiretroviral therapy (cART) or upon cART re-initiation after an analytical treatment interruption (ATI). These strategies aim to achieve sustained treatment-free remission in people living with HIV. The opportunity emphasizes basic research and preclinical intervention efforts that explore novel mechanisms and experimental interventions, excluding clinical trials. Proposed research should focus on interventions near the time of cART initiation to reduce HIV reservoir size or enhance immune responses. Acceptable studies include longitudinal reservoir decay studies, primary cell-based models, animal models using HIV/SIV/SHIV, and use of clinical samples from other funded trials. Projects should demonstrate innovative approaches, conceptual rigor, and potential for translation to future clinical interventions. Applications proposing strategies more than one month post-cART initiation or that utilize FDA-approved therapies without mechanistic justification are deemed non-responsive. The program encourages the involvement of early-stage investigators, team science, and private sector collaborations, particularly in product development. Applications must follow the SF424 (R&R) Application Guide and NIH's updated submission and review frameworks. The maximum project duration is five years with no set budget cap, but proposed budgets must match the scope and needs of the project. Multiple application types are allowed, including new, renewal, and resubmission applications. Applicant organizations must be registered with SAM, eRA Commons, and Grants.gov, and individuals must have eRA Commons accounts. Applications are due by NIH’s standard AIDS submission dates through September 7, 2026, with a current expiration date of May 24, 2025. Submissions are electronic only and must adhere strictly to NIH formatting and submission rules. Contact points are listed for both scientific inquiries and grants management for each participating institute. Additional information on human subjects, inclusion policies, and data sharing must be included per NIH guidelines.