Opportunity Information: Apply for RFA MH 13 031
Apply for RFA MH 13 031
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Eradication of HIV 1 from CNS Reservoirs Implications for Therapeutics (R21)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242 Mental Health Research Grants 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Feb 17, 2012 and posted on Feb 17, 2012.
- Applicants must submit their applications by Sep 12, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities State governments City or township governments County governments Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education For profit organizations other than small businesses Independent school districts Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Small businesses Private institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Eradication of HIV-1 from CNS Reservoirs: Implications for Therapeutics (R21) funding opportunity (RFA-MH-13-031) was a National Institutes of Health (NIH) research grant announcement led jointly by the National Institute of Mental Health (NIMH) and the National Institute of Neurological Disorders and Stroke (NINDS). It targeted a very specific and persistent barrier to HIV cure efforts: HIV-1 that remains in the central nervous system (CNS) even when a person is on effective Highly Active Antiretroviral Therapy (HAART). The core purpose was to stimulate early-stage, high-risk/high-reward projects that could clarify how HIV persists in the brain and spinal cord, and then use that knowledge to point toward realistic eradication strategies that work in the CNS setting rather than only in blood or peripheral tissues.
A defining feature of the announcement is its exclusive focus on CNS reservoirs. In other words, the research needed to be centered on HIV-1 persistence, latency, and rebound as they occur in the CNS compartment, including the unique biological constraints of the brain environment. This emphasis reflects longstanding concerns that the CNS can function as a sanctuary site because of the blood-brain barrier, distinct immune surveillance, and potentially different infected cell types compared to the periphery. Even when systemic viral loads are suppressed, residual virus or viral products in the CNS may contribute to ongoing inflammation, neurologic complications, and the risk of rebound if therapy is interrupted. The FOA therefore aimed to push the field beyond general HIV reservoir research into work that is explicitly relevant to the brain.
The announcement highlighted five priority research areas. First, it encouraged basic studies to identify and characterize the actual CNS-based cellular reservoirs that harbor HIV-1 in individuals receiving HAART. This includes pinning down which brain-resident or CNS-associated cell populations contain viral genomes, whether those genomes are intact/replication-competent, and how these infected cells are distributed and maintained over time. Second, it called for mechanistic work on how these reservoirs are established, maintained, and later resurge. That includes the timing of CNS seeding relative to initial infection and HAART initiation, the effects of antiretroviral penetration into the CNS, and how viral expression and viral evolution may differ in the brain compared with other compartments. Third, it sought development of more physiologically relevant animal models and CNS-focused cellular assays that can genuinely reproduce persistence and latency under conditions that mimic effective HAART, since many standard models fail to capture CNS pharmacology and the brain microenvironment in a way that predicts clinical behavior.
Fourth, the FOA supported drug screening efforts aimed specifically at agents that can cross the blood-brain barrier and eliminate latent infection or other sources of residual virus in the CNS. This priority recognizes that cure-oriented compounds that look promising in peripheral blood assays may fail in the CNS if they cannot reach adequate concentrations, are actively effluxed, or trigger unacceptable neurotoxicity. Screening in CNS-relevant systems was therefore a central theme, not an add-on. Fifth, it encouraged the design of therapeutic strategies aimed at actual eradication of HIV-1 from the CNS. This could include combinations of approaches (for example, latency-reversing or latency-silencing concepts paired with immune-based clearance, gene-based strategies, or novel delivery systems) as long as the work remained anchored to CNS eradication challenges rather than generalized cure strategies.
The activity mechanism was the NIH R21 exploratory/developmental grant, signaling an interest in innovative concepts, proof-of-principle data, and enabling technologies rather than large-scale definitive clinical trials. The award ceiling listed for the opportunity was $200,000, with no cost sharing or matching requirement. While the announcement was posted in February 2012 and closed in September 2012 (and later archived), the structure illustrates how NIH was attempting to accelerate early innovation in a space where conventional approaches had struggled: eliminating virus in a compartment protected by specialized anatomy, pharmacology, and immunology.
Eligibility was broad and included many types of organizations, reflecting an intent to pull in diverse expertise. Eligible applicants spanned public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3) entities), for-profit organizations (other than small businesses, though small businesses were also listed), and multiple levels of government entities. The FOA also explicitly allowed non-U.S. (foreign) institutions to apply, permitted non-U.S. components of U.S. organizations, and allowed foreign components as defined by NIH policy. It additionally called out eligibility for institutions serving specific populations (such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, and Alaska Native and Native Hawaiian-serving institutions), as well as faith-based and community-based organizations, signaling that NIH wanted to reduce barriers to participation and encourage capacity across sectors.
From a practical standpoint, the opportunity encouraged multidisciplinary teams but did not require them. That matters because CNS HIV persistence sits at the intersection of neurology, virology, immunology, pharmacology, and model development. Competitive applications would therefore likely combine expertise in CNS biology and neuropathology, viral latency measurement, antiretroviral CNS pharmacokinetics, blood-brain barrier transport, advanced imaging or tissue analysis, and translational therapeutic design. At the same time, the R21 format meant smaller, tightly focused projects were appropriate as long as they were genuinely novel and could move the field toward CNS-specific eradication strategies.
FAQs: The Eradication of HIV-1 from CNS Reservoirs: Implications for Therapeutics (R21) (RFA-MH-13-031)
What is this funding opportunity?
This opportunity, titled The Eradication of HIV-1 from CNS Reservoirs: Implications for Therapeutics (R21) (RFA-MH-13-031), was an NIH research grant announcement using the R21 exploratory/developmental activity mechanism. It was jointly led by the National Institute of Mental Health (NIMH) and the National Institute of Neurological Disorders and Stroke (NINDS).
What problem is the FOA trying to solve?
It targeted a specific barrier to HIV cure efforts: HIV-1 that can persist in the central nervous system (CNS) even when a person is on effective Highly Active Antiretroviral Therapy (HAART). The focus was on understanding persistence in the brain and spinal cord and using that knowledge to inform realistic eradication strategies that work in the CNS, not just in blood or peripheral tissues.
Why does the FOA focus exclusively on CNS reservoirs?
The CNS can act as a sanctuary site due to factors such as the blood-brain barrier, distinct immune surveillance, and potentially different infected cell types compared with peripheral tissues. Even when systemic viral loads are suppressed, residual virus or viral products in the CNS may contribute to ongoing inflammation, neurologic complications, and risk of viral rebound if therapy is interrupted. This FOA pushed research to be explicitly relevant to the brain compartment.
What type of projects was NIH trying to stimulate?
The FOA aimed to stimulate early-stage, high-risk/high-reward projects. The emphasis was on innovative concepts, proof-of-principle data, and enabling technologies that could clarify how HIV persists in the CNS and point toward CNS-specific eradication strategies.
Is this opportunity about general HIV reservoir research?
No. A defining feature was that the research needed to be centered on HIV-1 persistence, latency, and rebound as they occur in the CNS compartment. The work needed to address the unique biological constraints of the brain environment rather than treating CNS considerations as a minor extension of peripheral reservoir studies.
What were the priority research areas highlighted in the FOA?
The FOA highlighted five priority areas:
- Basic studies to identify and characterize CNS-based cellular reservoirs in individuals receiving HAART (including which cell populations contain viral genomes, whether genomes are intact/replication-competent, and how infected cells are distributed and maintained).
- Mechanistic studies on how CNS reservoirs are established, maintained, and resurge (including timing of CNS seeding, effects of antiretroviral penetration into the CNS, and how viral expression/evolution may differ in the CNS).
- Development of physiologically relevant animal models and CNS-focused cellular assays that reproduce persistence/latency under conditions that mimic effective HAART.
- Drug screening for agents that can cross the blood-brain barrier and eliminate latent infection or other sources of residual virus in the CNS, using CNS-relevant systems.
- Design of therapeutic strategies aimed at eradication of HIV-1 from the CNS (including combination strategies, as long as they remain anchored to CNS eradication challenges).
What does it mean that this was an R21 opportunity?
The R21 mechanism is intended for exploratory and developmental research. In this FOA, that translated into an emphasis on novel ideas and early enabling work rather than large-scale, definitive clinical trials. Smaller, tightly focused projects were appropriate if they were genuinely innovative and moved the field toward CNS-specific eradication approaches.
What was the maximum award amount?
The award ceiling listed for the opportunity was $200,000.
Was cost sharing or matching required?
No. The FOA specified that there was no cost sharing or matching requirement.
When was the FOA posted and when did it close?
The announcement was posted in February 2012 and closed in September 2012. It was later archived.
Which NIH institutes led this announcement?
It was led jointly by the National Institute of Mental Health (NIMH) and the National Institute of Neurological Disorders and Stroke (NINDS).
What kinds of organizations were eligible to apply?
Eligibility was broad. It included public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), for-profit organizations (other than small businesses, though small businesses were also listed), and multiple levels of government entities.
Were non-U.S. (foreign) institutions allowed to apply?
Yes. The FOA explicitly allowed non-U.S. (foreign) institutions to apply. It also permitted non-U.S. components of U.S. organizations and allowed foreign components as defined by NIH policy.
Did the FOA encourage participation from institutions serving specific populations?
Yes. The FOA called out eligibility for institutions such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, and Alaska Native and Native Hawaiian-serving institutions. It also included faith-based and community-based organizations, reflecting an interest in broad participation across sectors.
Were multidisciplinary teams required?
No. The opportunity encouraged multidisciplinary teams but did not require them.
What kinds of expertise would likely be relevant for strong applications?
Because CNS HIV persistence sits at the intersection of multiple fields, competitive applications would likely draw on expertise such as CNS biology and neuropathology, virology and viral latency measurement, immunology, antiretroviral CNS pharmacokinetics, blood-brain barrier transport, advanced imaging or tissue analysis, model development, and translational therapeutic design. The FOA still allowed smaller teams if the project was tightly focused and clearly novel.
What kinds of models or assays did the FOA encourage?
It encouraged development of more physiologically relevant animal models and CNS-focused cellular assays that can reproduce persistence and latency under conditions that mimic effective HAART. A key motivation was that standard models often fail to capture CNS pharmacology and the brain microenvironment in a way that predicts clinical behavior.
How did the FOA treat drug screening for cure-oriented compounds?
Drug screening was a central theme, not an add-on. The FOA supported screening efforts aimed specifically at agents that can cross the blood-brain barrier and address latent infection or other sources of residual virus in the CNS, recognizing that compounds that look promising in peripheral blood assays may fail in the CNS due to poor penetration, efflux mechanisms, or neurotoxicity concerns.
What did the FOA mean by "therapeutic strategies" for CNS eradication?
The FOA encouraged therapeutic strategies aimed at actual eradication of HIV-1 from the CNS. It allowed combination concepts (for example, latency-reversing or latency-silencing paired with immune-based clearance, gene-based strategies, or novel delivery systems), as long as the approach stayed anchored to CNS-specific eradication challenges rather than generalized cure strategies.
What aspects of CNS persistence did the FOA want mechanistic insight into?
Mechanistic work was encouraged on how CNS reservoirs are established, maintained, and later resurge. Examples mentioned include the timing of CNS seeding relative to initial infection and HAART initiation, the effects of antiretroviral penetration into the CNS, and differences in viral expression and viral evolution in the brain compared with other compartments.
Did the FOA emphasize measuring whether viral genomes are intact or replication-competent in CNS cells?
Yes. Within the priority area on identifying and characterizing CNS-based cellular reservoirs, the FOA explicitly referenced determining whether viral genomes present in CNS-associated cells are intact and/or replication-competent, in addition to identifying the cell populations and their distribution and maintenance over time.
What was the practical intent behind using an R21 for this topic?
The structure reflects an NIH effort to accelerate early innovation in a difficult space: eliminating virus in a compartment protected by specialized anatomy, pharmacology, and immunology. The R21 format aligned with testing bold ideas and generating proof-of-concept evidence rather than funding large, late-stage programs.
Browse more opportunities from the same category: Health
Next opportunity: Targeting Persistent HIV Reservoirs (TaPHIR) (R21/R33)
Previous opportunity: Eradication of HIV 1 from CNS Reservoirs Implications for Therapeutics (R01)
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