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




September 20, 2023



September 7, 2026



Award Floor:


Match Required?





Entity Types:

State governments, County governments, City or township governments, Special district governments, Independent school districts, Public & State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities, Native American tribal organizations, Nonprofits (with 501(c)(3) status), Nonprofits (without 501(c)(3) status)

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.




Source Type:


The purpose of this Notice of Funding Opportunity (NOFO) is to identify cure strategies suitable for administration at the start of combination antiretroviral therapy (cART) and/or at cART restart after an analytical treatment interruption (ATI), with the ultimate goal of achieving sustained treatment-free remission. The scientific objective of this NOFO is to explore HIV cure strategies administered during ongoing HIV/SHIV/SIV infection, close to the time of cART initiation, before viral loads are completely suppressed, or after an analytical treatment interruption (ATI) to potentially enhance the HIV-specific immune response and/or reduce reservoir size. In addition to early cure interventions, a deeper understanding of the decay dynamics of virus-infected cell subsets following cART initiation is also needed. Therefore, longitudinal studies of the viral reservoir early in active infection and immediately after cART initiation will also be supported to inform the development of new cure strategies.

This NOFO aims to support basic research and targeted intervention activities. Basic research into novel mechanisms that contribute to intervention-mediated viral control and reductions in reservoir size will be important. The targeted interventions studied should be experimental, innovative, and not yet approved by the FDA or a foreign regulatory agency for an HIV indication.

Although clinical trials are not allowed, the use of samples from clinical trials supported by other funding mechanisms is encouraged. Besides human samples, studies in animal models, using HIV, SIV, or SHIV, are allowed. Preferentially, therapeutic strategies should be evaluated in an in vitro primary cell-based model prior to commencing in vivo studies. Early HIV/SIV interventions without cART that have demonstrated a clear antiviral effect in previous studies are also allowed.

Early HIV/SIV cure strategies without cART that demonstrated a clear antiviral effect in previous studies are allowed.

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