Opportunity Information: Apply for RFA AI 13 055

  • The National Institutes of Health 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): 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
  • This funding opportunity was created on Nov 25, 2013 and posted on Oct 24, 2013.
  • Applicants must submit their applications by Jul 15, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $4,000,000.00 to eligible and selected applicants.
  • Eligible applicants include: Small businesses For profit organizations other than small businesses Private institutions of higher education Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) County governments Special district governments Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments State governments Independent school districts.
  • 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) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:

The Pilot Clinical Trials to Eliminate the Latent HIV Reservoir (U01) opportunity, Funding Opportunity Number RFA-AI-13-055, is a National Institutes of Health (NIH) cooperative agreement designed to support early, tightly focused clinical trials that test strategies intended to eliminate the latent HIV reservoir in adults living with HIV who are already receiving suppressive antiretroviral therapy (ART). The central scientific aim is to move beyond controlling viral replication and instead evaluate interventions that can reduce or eradicate long-lived, latently infected cells that persist despite effective ART and are widely recognized as the major barrier to a cure. Because this is a U01 cooperative agreement, applicants should expect substantial NIH program involvement during trial planning and execution, with an emphasis on coordinated milestones, close oversight, and collaborative problem-solving typical of cooperative mechanisms.

A defining feature of this FOA is that proposed pilot trials are expected to be fully integrated with laboratory-based analytical tools capable of detecting and quantifying changes in the latent reservoir. The announcement stresses measuring elimination (or meaningful reduction) of latently infected cells not only in blood, but also in tissue, reflecting the reality that HIV persistence can be compartmentalized and may not be adequately captured by peripheral blood testing alone. In practice, this means strong applications would pair clinical interventions with robust virologic and immunologic assays and include a clear plan for sampling, reservoir measurement, and interpretation of reservoir dynamics, rather than treating laboratory evaluation as an afterthought.

The opportunity falls under the NIH health research activity area and is associated with CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). The total estimated funding level listed for the FOA is $4,000,000, and the announcement explicitly indicates that there is no cost sharing or matching requirement. The FOA was posted on October 24, 2013, with an original closing date of March 7, 2014, later reflected with a current closing date of July 15, 2014, and an archive date of August 15, 2014. Even though these dates indicate the opportunity is historical/archived, the content still illustrates NIH priorities and expectations for pilot cure-oriented clinical trial design in this area.

Eligibility is broad across U.S.-based organizations and governmental entities. Eligible applicants include small businesses and other for-profit organizations, public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), and a range of government bodies such as state governments, county governments, city or township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities. The FOA also clarifies additional eligible applicant types, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and eligible federal agencies. Non-U.S. (foreign) institutions and non-U.S. components of U.S. organizations are not eligible to apply, although foreign components, as defined by the NIH Grants Policy Statement, are allowed, which typically means discrete foreign collaborations can be included when well-justified and compliant with NIH policy.

Operationally, applicants are directed to the full announcement for detailed requirements and submission instructions via the NIH Grants Guide link provided (http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-13-055.html). For access or linking problems, the FOA provides NIH Office of Extramural Research (OER) webmaster contact information (FBOWebmaster@OD.NIH.GOV). Overall, the FOA is centered on translating cure-directed reservoir elimination concepts into carefully designed pilot clinical trials, with success dependent on rigorous integration of clinical intervention protocols and state-of-the-art reservoir measurement in both blood and tissue.

FAQs: Pilot Clinical Trials to Eliminate the Latent HIV Reservoir (U01) - RFA-AI-13-055

What is this funding opportunity?

This is the NIH Funding Opportunity Announcement (FOA) titled Pilot Clinical Trials to Eliminate the Latent HIV Reservoir (U01), Funding Opportunity Number RFA-AI-13-055. It supports early, tightly focused clinical trials that test strategies intended to eliminate (or meaningfully reduce) the latent HIV reservoir.

What type of NIH award is this?

The FOA uses a U01 cooperative agreement mechanism. A cooperative agreement means NIH program staff are expected to have substantial involvement in planning and executing the study, including coordinated milestones, close oversight, and collaborative problem-solving.

What is the central scientific goal of the FOA?

The primary aim is to move beyond simply controlling viral replication and instead evaluate interventions designed to reduce or eradicate long-lived, latently infected cells that persist despite effective antiretroviral therapy (ART). These latent reservoirs are described as a major barrier to an HIV cure.

Who is the target study population for the proposed clinical trials?

The FOA is focused on adults living with HIV who are already receiving suppressive antiretroviral therapy (ART).

What kinds of studies are expected to be proposed?

The announcement emphasizes pilot clinical trials that are early-stage and tightly focused, aimed specifically at strategies intended to eliminate or reduce the latent HIV reservoir.

How important are laboratory measurements in this FOA?

Laboratory evaluation is a defining feature. Proposed pilot trials are expected to be fully integrated with laboratory-based analytical tools capable of detecting and quantifying changes in the latent reservoir. The FOA stresses that reservoir measurement should be central to the trial design rather than treated as an add-on.

Does the FOA expect reservoir measurements only in blood?

No. The FOA specifically stresses measuring elimination (or meaningful reduction) of latently infected cells not only in blood but also in tissue, reflecting that HIV persistence can be compartmentalized and may not be adequately captured by peripheral blood testing alone.

What types of assays or tools are implied as important?

The FOA highlights the need for robust virologic and immunologic assays and a clear plan for sampling, reservoir measurement, and interpretation of reservoir dynamics. The emphasis is on analytical tools that can detect and quantify changes in the latent reservoir.

What does "cooperative agreement" mean for applicants in practice?

Applicants should expect substantial NIH program involvement during both trial planning and execution. The FOA describes this as coordinated milestones, close oversight, and collaborative problem-solving that are typical of cooperative mechanisms like the U01.

What is the estimated total funding level for this FOA?

The FOA lists a total estimated funding level of $4,000,000.

Is there a cost sharing or matching requirement?

No. The FOA explicitly indicates no cost sharing or matching requirement.

What NIH activity area does this opportunity fall under?

The FOA falls under the NIH health research activity area and is associated with CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).

Who is eligible to apply?

Eligibility is broad across U.S.-based organizations and governmental entities. Eligible applicants include small businesses and other for-profit organizations; public and private institutions of higher education; nonprofit organizations (including those with and without 501(c)(3) status); and multiple levels of government such as state, county, and city or township governments.

Are special district governments and independent school districts eligible?

Yes. The FOA lists special district governments and independent school districts among eligible applicant types.

Are public housing authorities eligible to apply?

Yes. The FOA includes public housing authorities/Indian housing authorities as eligible applicants.

Are minority-serving institutions included in eligibility?

Yes. The FOA explicitly lists eligibility for Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).

Are faith-based or community-based organizations eligible?

Yes. The FOA states that faith-based or community-based organizations are eligible applicants.

Are U.S. territories or possessions eligible?

Yes. The FOA includes U.S. territories or possessions among eligible applicant types.

Are federal agencies eligible to apply?

Yes. The FOA states that eligible federal agencies may apply.

Are non-U.S. (foreign) institutions eligible to apply?

No. The FOA states that non-U.S. (foreign) institutions and non-U.S. components of U.S. organizations are not eligible to apply.

Can the project include any foreign involvement at all?

Yes, potentially. While foreign institutions cannot apply as the applicant organization, the FOA notes that foreign components, as defined by the NIH Grants Policy Statement, are allowed. This generally means discrete, well-justified foreign collaborations may be included when compliant with NIH policy.

Where can applicants find the full FOA and submission instructions?

The FOA directs applicants to the NIH Grants Guide announcement page for detailed requirements and submission instructions: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-13-055.html.

What should someone do if they have access or linking problems with the FOA webpage?

The FOA provides NIH Office of Extramural Research (OER) webmaster contact information for access/linking issues: FBOWebmaster@OD.NIH.GOV.

When was this FOA posted and what are the key dates mentioned?

The FOA was posted on October 24, 2013. It lists an original closing date of March 7, 2014, later reflected with a current closing date of July 15, 2014, and an archive date of August 15, 2014.

Is this an active funding opportunity?

The dates provided indicate the opportunity is historical/archived. Even so, the FOA content illustrates NIH priorities and expectations for pilot cure-oriented HIV reservoir elimination trial design.

What makes an application align well with the FOA’s expectations?

Based on the FOA description, strong alignment would include a carefully designed pilot clinical trial paired with rigorous virologic and immunologic assays, with a clear plan for sampling in both blood and tissue, reservoir measurement, and interpretation of reservoir dynamics, alongside readiness to work within the close-collaboration structure of a U01 cooperative agreement.

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