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

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Description

This NIH R21 funding opportunity supports exploratory and developmental research to identify and evaluate HIV cure strategies that can be administered at the initiation of combination antiretroviral therapy (cART) or at cART restart after an analytical treatment interruption (ATI). The ultimate goal is to achieve sustained, treatment-free HIV remission. The program encourages innovative basic research and preclinical intervention studies, including mechanistic studies of viral reservoir dynamics and targeted interventions to limit reservoir seeding or enhance immune control at the time of ART initiation.

Clinical trials are not permitted under this opportunity, but the use of samples from existing clinical trials is encouraged. Both human and animal model studies are eligible, and applications from multidisciplinary teams, early-stage investigators, and those with private sector partners are encouraged.

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Due Dates

• May 7, 2025
• September 7, 2025
• January 7, 2026
• May 7, 2026
• September 7, 2026

All applications are due by 5:00 PM local time of the applicant organization. These are AIDS-specific due dates; standard R21 due dates do not apply.

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Funding Amount

• Maximum direct costs: $275,000 over a two-year project period.
• No more than $200,000 in direct costs may be requested in any single year.
• Project period: Up to 2 years.
• Indirect costs are in addition to direct costs, per NIH policy.

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Eligibility

Eligible Applicants:

• Public and private institutions of higher education (domestic and foreign)
• Nonprofits (with or without 501(c)(3) status)
• For-profit organizations (including small businesses)
• State, county, city, township, and special district governments
• Independent school districts
• Public housing authorities/Indian housing authorities
• Native American tribal governments (federally recognized and other)
• Faith-based and community-based organizations
• Regional organizations
• U.S. territories and possessions
• Non-domestic (non-U.S.) entities (foreign organizations) and components of U.S. organizations

Eligible Individuals:

• Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as PD(s)/PI(s).

Additional Notes:

• Multiple applications from the same institution are allowed if scientifically distinct.
• Foreign components are permitted.
• Cost sharing is not required.

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Application Process

• Applications must be submitted electronically via Grants.gov, using the NIH ASSIST system, Grants.gov Workspace, or an institutional system-to-system solution.
• Follow the NIH SF424 (R&R) Application Guide and the specific instructions in the NOFO (PAR-23-296).
• All required registrations (SAM, eRA Commons, Grants.gov) must be completed prior to submission.
• Applications must include a Data Management and Sharing Plan.
• Only limited appendix materials are allowed.
• Letters of support are required for all collaborators.

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Additional Information

• Scope: Supports basic and preclinical research only; clinical trials are not allowed.
• Research Focus: Strategies must be administered at or near the time of cART initiation or restart (within one month), or after ATI. Interventions started later or cART intensification alone are not responsive.
• Examples of responsive research:
  • Studies of HIV reservoir seeding and decay at ART initiation
  • Preclinical evaluation of novel cure/remission strategies at ART start
  • Mechanistic studies of immune responses or reservoir dynamics
• Non-responsive applications: Those proposing interventions more than one month after cART initiation, cART intensification alone, or use of FDA-approved drugs as cure interventions without mechanistic rationale.

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External Links

• Full Funding Opportunity Announcement (PAR-23-296)
• NIH Grants & Funding Home
• Apply via Grants.gov
• NIH Application Guide (Forms-H)

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Contact Information

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