Request for Information (RFI): Public Comment on Development of a Funding Opportunity Announcement on HIV Persistence

Notice Number: NOT-AI-09-013

Key Dates
Release Date:   November 12, 2008
Opening Date:   November 21, 2008
Closing Date:   January 15, 2009

The email address for this RFI will not be available after Close of Business January 15, 2009

Issued by
National Institute of Allergy and Infectious Diseases (http://www.niaid.nih.gov)

Purpose

NIAID is seeking input from the scientific community regarding research on the nature of HIV persistence and the development of strategies for diminishing or eradicating sources of virus remaining despite optimal antiretroviral treatment (residual viremia).  Recent scientific advances suggest that renewed efforts are warranted in this area of HIV research.  The information obtained from responses to this RFI will aid the Division of AIDS (DAIDS), NIAID, in developing a future Funding Opportunity Announcement (FOA).
 
Background

Residual viremia can be detected in HIV-infected persons on effective combination antiretroviral treatment, at a level of <50 copies per ml.  The level of viremia appears to be independent of the particular regimen and is not affected by intensification of the regimen with additional drugs.  This suggests that the potential of the currently available drugs to eliminate virus has been reached and that new treatment goals should be adopted.  The source of residual viremiaremains a subject of debate.   Further basic research is needed to understand the source of residual viremia, the molecular mechanisms that facilitate persistence, and potential therapeutic strategies to specifically target residual virus reservoirs.

Two new treatment goals have been proposed by the HIV scientific community:  long term remission without treatment (functional cure) or eradication.  The NIAID wishes to explore the possibility of developing a new initiative to move toward these goals through basic research and developmental activities.  To facilitate progress, the NIAID is proposing a new organizational format for the research, i.e. a “collaboratory” composed of academia, the private sector, and Government, with the maximum flexibility possible for making decisions on how to mobilize resources and meet objectives.

Information Requested

In order to aid the conceptualization of the anticipated FOA, this RFI invites the scientific community to respond to the following items, keeping in mind the model of a collaboration among academia, the private sector, and Government.

1.  Indicate what research should be included.  In other words, describe what new basic information, technologies, and resources are needed to make progress in this area.  Indicate whether  animal models and/or pilot clinical studies should be included.

2.  Indicate what research should be excluded.  In other words, describe what approaches have already been, or are currently being, explored at a sufficient level.

3.  Describe what would be the optimal configuration for research collaboration between academia and the private sector to work on this problem.  Describe how  the collaboration should be governed and what would be the respective roles and contributions of the partners.  

4.  Describe whether there is value added to pursuing this research within a collaborative framework or whether  the traditional investigator initiated mechanisms work just as well, or possibly better.

Responses

Responses will be accepted until COB (5:00pm EST) January 15, 2009 and may be sent to the following email address:   [email protected]

You are asked to limit your total response to a maximum of 5 pages.

This RFI shall not be construed as a solicitation for applications or as an obligation on the part of the Government.  The Government will not pay for the preparation of any information submitted. Responders should be aware that the information provided will be analyzed and may be used to develop future funding opportunity announcements and/or appear in various reports. The Government cannot guarantee the confidentiality of the information provided.

Inquiries

Questions about this request for information may be directed to:

Sandra Bridges PhD
Basic Sciences Program
Division of AIDS, NIAID, NIH
Telephone: 301 496 8198
Email: [email protected]

Or

Sarah Read MD
Treatment Research Program
Division of AIDS, NIAID, NIH
Telephone:   301 451 2757
Email:  [email protected]