June 2023 DAIDS Council-Approved Concepts

Concepts represent early planning stages for program announcements, requests for applications, notices of special interest, or solicitations for Council's input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to Opportunities & Announcements.

Note: Council approval does not guarantee that a concept will become an initiative.

Table of Contents

Fiscal Year (FY) 2024 Division of AIDS (DAIDS) Concept

FY 2025 DAIDS Concepts

Notice of Special Interest (NOSI)—HIV Cure-Related Research in Diverse Populations

For the published notice of special interest, check the June 23, 2023 Guide notice, Notice of Special Interest (NOSI)—HIV Cure-Related Research in Diverse Populations.

Mechanisms of Inducing HIV Immunity in Early Life

For the published request for applications, check the June 18, 2024 Guide announcement, Mechanisms of Inducing HIV Immunity in Early Life (MIEL) (U01, Clinical Trial Not Allowed). 

HIV Vaccine Research and Design (HIVRAD) Program

For the published program announcement with special receipt, referral, and/or review considerations, check the October 4, 2023 Guide announcement, HIV Vaccine Research and Design (HIVRAD) Program (P01, Clinical Trial Not Allowed).

Virology Core Laboratory

For the published request for proposals, check the September 7, 2023 solicitation, Virology Core Laboratory.

Humoral Immunology Core Laboratory for AIDS Vaccine Research and Development

For the published request for proposals, check the November 17, 2023 solicitation, Humoral Immunology Core Laboratory for AIDS Vaccine Research.

Functional Omics Core Laboratory

For the published request for proposals, check the February 16, 2024 solicitation, Functional Omics Laboratory.

Resource Support Program for AIDS Vaccine Development

For the published request for proposals, check the November 1, 2023 solicitation, Resource Support Program for AIDS Vaccine Development.

Planning for Product Development Strategy

For the published program announcement with special receipt, referral, and/or review considerations, check the December 30, 2024 Guide announcement, Planning for Product Development Strategy (R34, Clinical Trial Not Allowed).

Engineering and Preclinical Development of Biological Products that Eliminate HIV-Infected Cells

For the published request for applications, check the October 25, 2023 Guide announcement, Engineering and Preclinical Development of Biological Products that Eliminate HIV-Infected Cells (UG3/UH3, Clinical Trial Not Allowed).

Multidisciplinary Research to Accelerate Hepatitis B Cure in Persons Living with HIV and HBV

For the published request for applications, check the October 10, 2023 Guide announcement, Multidisciplinary Research to Accelerate Hepatitis B Cure in Persons Living with HIV and HBV (U19, Clinical Trial Not Allowed).

Developing a Pipeline of Cell and Gene Therapies for HIV Cure

For the published request for applications, check the April 8, 2024 Guide announcement, Cell and Gene Therapies for HIV Cure: Developing a Pipeline (P01, Clinical Trial Not Allowed).

Tailoring HIV Curative Strategies to the Individual

Request for Applications—proposed FY 2025 initiative

Contact:
Leia Novak
leia.novak@nih.gov

Objective: To determine whether tailoring curative strategies to an individual’s specific intact, rebound-competent proviral reservoir and immunologic profile might be more successful than existing, more general approaches at achieving HIV reservoir reduction and/or induction of durable control of viral rebound. The goal is to enable proof-of-concept studies to demonstrate that combination interventions can generate a cure under optimal conditions. This will help guide subsequent prioritization of translational research and optimization of approaches so that they are effective across broader populations of individuals.

Description: This initiative will bring together multidisciplinary teams with expertise in virology, immunology, single-cell analytics, and bioinformatics/modeling to characterize the landscapes of: intact and defective proviruses, host HLA alleles, CD4+ and CD8+ T cell receptor repertoires, and autologous or heterologous neutralizing antibody specificities in virally-suppressed individuals on treatment, and use that information to design combinations of interventions specifically tailored to be effective at targeting and controlling those individuals’ HIV reservoirs.

The scope of research will include basic and preclinical research, methods development and validation, analysis of clinical samples including accessible tissue samples, and testing of combinations of specifically tailored cure strategies in vitro or ex vivo. The focus should be on HIV in humans, but some testing in animal model systems will be permitted if appropriate and well justified. The strategy should be validated across a group of individuals and compared to non-tailored controls to demonstrate rigor, reproducibility, and significance of the results. The curative strategy must combine at least two different immunologic approaches that target an individual’s proviral reservoir sequences – for example, combining adaptive cellular responses with humoral HIV-gene-specific targeted approaches. Non-immunologic tailored approaches, such as gene editing of provirus or CCR5, LTR targeting, or block-and-lock strategies will not be responsive. The research plan should also include a tailored strategy for reactivation of reservoir cells – for example, targeting based on the antigenic specificity of the reservoir cells.

Clinical trials are not allowed, but use of blood and tissue samples from clinical trials funded through separate mechanisms will be encouraged. The proposal should take into account the requirements for downstream implementation of the tailored approach in future clinical trials, such as discussion of regulatory requirements for interventions and diagnostic assays and how GMP materials would be produced.

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