Opportunity Information: Apply for RFA AI 16 012
Apply for RFA AI 16 012
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Pilot Clinical Trials to Eliminate the Latent HIV Reservoir (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 93.855, 93.856.
- This funding opportunity was created on Mar 10, 2016 and posted on Mar 10, 2016.
- Applicants must submit their applications by Jul 26, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The funding opportunity titled "Pilot Clinical Trials to Eliminate the Latent HIV Reservoir (U01)" (Funding Opportunity Number RFA AI 16 012) is a National Institutes of Health (NIH) initiative under the U.S. Department of Health and Human Services. It uses a cooperative agreement mechanism (U01), which means the project is not simply funded and left to run independently; instead, NIH staff are expected to have substantial scientific and programmatic involvement during the life of the award. The overall goal of the announcement is to move promising cure-oriented HIV strategies into early, pilot-scale human clinical trials specifically focused on eliminating the latent HIV reservoir, the long-lived population of infected cells that persists despite effective antiretroviral therapy and is the main barrier to a cure.
The FOA is centered on clinical testing of interventions designed to eliminate cells that harbor latent HIV. In practical terms, it is aimed at supporting trials that go beyond measuring standard clinical outcomes and instead directly evaluate whether an intervention can reduce or eradicate the hidden pool of infected cells that remain in the body when HIV is suppressed to undetectable levels in blood. This kind of work typically involves approaches such as latency-reversing agents (to "wake up" dormant virus so infected cells can be targeted), immune-based therapies (to enhance recognition and killing of infected cells), therapeutic vaccines, engineered cell approaches, antibodies, combinations of modalities, or other strategies intended to either directly clear latently infected cells or make them vulnerable to elimination. Because this is framed as a pilot clinical trial program, the expectation is generally to generate strong feasibility, safety, and biologic proof-of-concept data that can justify larger, definitive studies later.
A defining feature of the announcement is its emphasis on tight integration between clinical trial activities and advanced laboratory measurements. Applicants are expected to incorporate robust, state-of-the-art laboratory methods to detect and quantify changes in the latent reservoir. The FOA explicitly calls for laboratory approaches that can measure elimination (or attempted elimination) of latently infected cells in blood and, when appropriate, in cerebrospinal fluid and tissue. This indicates that NIH intended these trials to include careful sampling and analytic plans, potentially including assays for cell-associated HIV DNA/RNA, viral outgrowth or equivalent reservoir quantification methods, immune profiling, and tissue-based assessments where scientifically justified. The mention of cerebrospinal fluid highlights interest in understanding and measuring reservoir dynamics in compartments relevant to the central nervous system, while the mention of tissue underscores that the reservoir is not confined to circulating blood and may require lymphoid or other tissue sampling to accurately assess intervention impact.
The opportunity is classified under the Health funding activity category and is associated with CFDA numbers 93.242, 93.855, and 93.856, reflecting NIH programs that support infectious disease and immunology research. Eligibility is broad and includes many types of domestic organizations: state, county, and municipal governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other entities as described in the FOA's additional eligibility language. This broad eligibility structure is typical of NIH clinical research announcements and is designed to allow academic medical centers, research institutes, hospitals, biotech/pharma partners, and other qualified organizations to participate, including multi-institution collaborations that combine clinical trial capacity with specialized laboratory expertise.
Key administrative details in the public listing include an original and current closing date of July 26, 2016, with the opportunity posted and created on March 10, 2016. The listing does not specify an award ceiling or the expected number of awards in the provided fields, which sometimes occurs when those details are described in the full FOA text rather than in the summary record. The sponsoring agency is identified as HHS-NIH11, which corresponds to NIH components involved in the solicitation (commonly within the National Institute of Allergy and Infectious Diseases for HIV cure-related initiatives, though the exact institute and program roles would be laid out in the full announcement).
In short, this FOA was designed to accelerate early human testing of HIV cure strategies that aim to remove the latent reservoir, with a strong expectation that clinical interventions be paired with rigorous, integrated laboratory measurements across relevant body compartments. The intended output is not only clinical safety and feasibility information, but also high-quality biologic evidence showing whether and how an intervention affects the persistence of latently infected cells in people living with HIV who are typically maintained on suppressive therapy.
FAQs: Pilot Clinical Trials to Eliminate the Latent HIV Reservoir (U01) - RFA AI 16 012
What is the title and funding opportunity number for this grant?
The opportunity is titled "Pilot Clinical Trials to Eliminate the Latent HIV Reservoir (U01)" and the Funding Opportunity Number is RFA AI 16 012.
Which federal agency is offering this opportunity?
This is a National Institutes of Health (NIH) funding opportunity under the U.S. Department of Health and Human Services (HHS).
What type of award mechanism is used?
The FOA uses a cooperative agreement mechanism (U01).
What does a U01 cooperative agreement mean for how the project is run?
A U01 is not a "hands-off" award. NIH staff are expected to have substantial scientific and programmatic involvement during the life of the award, meaning the work is conducted in collaboration with NIH involvement rather than operating entirely independently.
What is the overall goal of this funding opportunity?
The goal is to move promising cure-oriented HIV strategies into early, pilot-scale human clinical trials that specifically focus on eliminating the latent HIV reservoir, which is the long-lived population of infected cells that persists despite effective antiretroviral therapy and represents a key barrier to curing HIV.
What is meant by the "latent HIV reservoir" in this FOA?
In this context, the latent reservoir refers to infected cells that can persist long-term even when antiretroviral therapy suppresses HIV to undetectable levels in blood. These cells can harbor HIV in a dormant state and can reignite infection if therapy is stopped.
What kind of clinical trials is this FOA trying to support?
This FOA is centered on pilot clinical trials in humans that test interventions designed to eliminate cells harboring latent HIV. The emphasis is on directly evaluating whether an intervention can reduce or eradicate the hidden pool of infected cells that remains despite suppressive therapy.
How is this different from a typical HIV clinical trial focused on standard clinical outcomes?
Rather than focusing only on standard clinical outcomes, the FOA emphasizes trials that directly evaluate effects on the latent reservoir itself, using advanced laboratory measurements to detect and quantify changes in latently infected cells.
What types of interventions are within scope for this FOA?
The FOA is aimed at cure-oriented strategies intended to eliminate latently infected cells or make them vulnerable to elimination. Examples mentioned include latency-reversing agents, immune-based therapies, therapeutic vaccines, engineered cell approaches, antibodies, and combinations of modalities, as well as other approaches aligned with eliminating the reservoir.
What is the expected scale and purpose of the trials funded under this announcement?
Because this is framed as a pilot clinical trial program, the expectation is to generate strong feasibility, safety, and biologic proof-of-concept data to justify larger, definitive studies later.
What role do laboratory measurements play in the proposed trials?
Laboratory measurements are a defining feature. Applicants are expected to tightly integrate clinical trial activities with robust, state-of-the-art laboratory methods designed to detect and quantify changes in the latent reservoir.
What compartments or sample types does the FOA highlight for reservoir measurement?
The FOA explicitly calls for laboratory approaches that can measure elimination (or attempted elimination) of latently infected cells in blood and, when appropriate, in cerebrospinal fluid and tissue.
Why does the FOA mention cerebrospinal fluid (CSF)?
The mention of CSF indicates interest in understanding and measuring reservoir dynamics in compartments relevant to the central nervous system, where HIV persistence may differ from what is observed in blood.
Why does the FOA mention tissue sampling?
The FOA highlights tissue because the latent reservoir is not confined to circulating blood. Tissue and lymphoid sites can be important reservoirs, and sampling may be needed (when scientifically justified) to accurately assess an intervention's impact.
What kinds of laboratory approaches are implied by the FOA summary?
The summary points to advanced approaches such as assays for cell-associated HIV DNA/RNA, viral outgrowth or equivalent reservoir quantification methods, immune profiling, and tissue-based assessments when appropriate.
What funding activity category is this opportunity listed under?
The opportunity is classified under the Health funding activity category.
Which CFDA numbers are associated with this FOA?
The listing associates this FOA with CFDA numbers 93.242, 93.855, and 93.856.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic organizations, including state, county, and municipal governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other entities as described in the FOA's additional eligibility language.
Does this FOA support collaborations across institutions?
The structure described is intended to allow multi-institution collaborations that combine clinical trial capacity with specialized laboratory expertise.
What is the application deadline shown in the public listing?
The original and current closing date shown is July 26, 2016.
When was the opportunity posted/created?
The listing indicates it was posted and created on March 10, 2016.
Is the award ceiling specified in the summary information provided?
No. The provided listing fields do not specify an award ceiling, which can happen when details are included in the full FOA text rather than in the summary record.
Is the expected number of awards specified in the provided summary?
No. The provided fields do not list the expected number of awards.
Who is the sponsoring agency identified in the listing?
The sponsoring agency is identified as HHS-NIH11 in the public listing.
What is the intended outcome of projects funded under this FOA?
The intended output includes clinical safety and feasibility information along with high-quality biologic evidence showing whether and how an intervention affects persistence of latently infected cells in people living with HIV who are typically maintained on suppressive therapy.
Does the FOA focus on people with HIV who are already on antiretroviral therapy?
Yes. The summary emphasizes the latent reservoir that persists despite effective antiretroviral therapy and discusses HIV being suppressed to undetectable levels in blood, indicating a focus on participants on suppressive therapy.
What is the central scientific emphasis of the FOA?
The central emphasis is accelerating early human testing of HIV cure strategies aimed at removing the latent reservoir, paired with rigorous, integrated laboratory measurements across relevant body compartments.
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