Notice of Change of Program Priorities to be Supported by PAR-12-109 “Targeting Persistent HIV Reservoirs (TaPHIR) (R21/R33)”

Notice Number: NOT-AI-14-023

Key Dates
Release Date: January 15, 2014

Related Announcements
PAR-12-109

Issued by
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The purpose of this Notice is to identify changes regarding program priorities for eligible research projects described in Funding Opportunity Announcement (FOA) PAR-12-109, “Targeting Persistent HIV Reservoirs (TaPHIR) (R21/R33)”. The following changes are made to align with the U.S. President’s initiative to expand support for research aimed at a cure or lifelong remission of HIV infection.

1) Applications that define the basic cellular and molecular mechanisms of HIV latency and persistence are requested.

2) The restrictions to the eligible research have been reduced to 'Clinical Trials not allowable' only.

In Part 2, Section I under Research Objectives and Scope, the following changes in language are indicated by bold text:

CURRENT LANGUAGE:
Specifically, applicants should address one or more of the following five research objectives:

  • Design approaches to specifically and efficiently target and eliminate latently HIV-infected cells in vivo. Elimination could be achieved via direct killing (e.g., using a therapeutic), by targeted removal or depletion, or by indirectly facilitating or directing a specific immune response (e.g. tagging cells for clearance by the immune system). Therapeutic HIV vaccines should not be proposed under this FOA.

NEW LANGUAGE:
Specifically, applicants should address one or more of the following six research objectives:

  • Design approaches to specifically and efficiently target and eliminate latently HIV-infected cells in vivo. Elimination could be achieved via direct killing (e.g., using a therapeutic), by targeted removal or depletion, or by indirectly facilitating or directing a specific immune response (e.g. tagging cells for clearance by the immune system).
  • Define the basic cellular and molecular mechanisms of HIV latency and persistence.

CURRENT LANGUAGE:
Note: Applications proposing any of the following will not be considered appropriate for this FOA. 

  • Approaches that are dependent on active HIV replication or ongoing HIV gene expression;
  • Studies that rely on intensification of antiretroviral therapy;
  • Approaches that involve non-specific reactivation of HIV gene expression through use of, for example, cytokines, HDAC inhibitors, DNA methyltransferase inhibitors, PKC activators, unless such reactivation is combined with a specific cell killing or HIV inactivation component and/or a novel, HIV-specific reactivation strategy;
  • Basic research studies of viral or cellular factors involved in latency without a clearly defined translational approach for which proof-of-concept will be determined during the term of the award;
  • Development of animal models to study HIV persistence, unless coupled with the testing of a novel strategy for eradication of viral reservoirs during the term of the award;
  • Concepts currently under clinical investigation, unless a component of a novel combination strategy
  • Therapeutic vaccines;
  • Clinical Trials.

Investigators addressing basic science questions concerning the nature of the persistent HIV reservoir and its maintenance should instead consider submitting their applications in response to PA-09-152 “Basic Research on HIV Persistence” (R01).

NEW LANGUAGE:
Note: Applications proposing any of the following will not be considered appropriate for this FOA. 

  • Clinical Trials.

All other aspects of the FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Karl Salzwedel, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-5332
Email: salzwedelkd@mail.nih.gov

 

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