NIH – Advancing technologies to improve delivery of pharmacological, gene editing, and other cargoes for HIV and SUD mechanistic or therapeutic research (R01- Clinical Trial Optional)

March 5, 2021 by dld5dt@virginia.edu

Purpose:

The purpose of this funding opportunity is to develop technologies to improve the delivery of pharmacological, gene editing, or other cargoes for HIV and SUD mechanistic research.

Background:

This initiative focuses on technologies to improve the delivery of pharmacological, gene editing, or other cargoes for HIV and SUD mechanistic or therapeutic research. The development of combination Anti-retroviral therapy for HIV has transformed HIV/AIDS into a chronic disease by suppressing viral replication to undetectable levels. However, even after combination anti-retroviral therapy, HIV reservoirs remain in the gut, the immune system, and the nervous system where HIV infected CD4+ T cells, macrophages, dendritic cells and microglia may reside. Thus, no cure has been found for HIV infection and no effective vaccine for HIV exists. Current anti-retroviral therapies also have problems with drug toxicity, bioavailability, and have not been formulated for sustained release. Long term sustained delivery is needed among people with substance use disorders where compliance with an anti-retroviral therapy regimen may be problematic. To address these issues the development of improved reagents or technologies to enable targeted delivery of reagents (e.g. small molecules, biologics, gene editing reagents, etc.) to particular CNS regions or cell types is of great interest. Such delivery systems would improve our ability to monitor or manipulate HIV and SUD processes and could serve as the foundation for improved future therapeutics for HIV and/or SUD. Targeted delivery of CRISPr/CAS9 constructs, a gene editing technology, to HIV reservoirs has the potential to eradicate and cure HIV. The effectiveness of gene editing technology may be enhanced through combination with nano-formulations of anti-retroviral therapeutic agents.Such nano-formulations could potentially reduce drug toxicity, improve bioavailability, and provide vehicles for sustained delivery to the periphery and the central nervous system. Sustained delivery formulations that suppress viral expression in the blood stream may eradicate HIV transmission as effectively as a vaccine among drug abusing populations who have problems with treatment compliance.

Applications without proposed technology developments to improve the delivery of cargoes for HIV and SUD research will be considered non-responsive and returned without review.

Design, Analysis, and Sample Size for Studies to Evaluate Group-Based Interventions: Investigators who wish to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome may propose a study in which (1) groups or clusters are assigned to study arms and individual observations are analyzed to evaluate the effect of the intervention, or (2) participants are assigned individually to study arms but receive at least some of their intervention in a real or virtual group or through a shared facilitator. Such studies may propose a parallel group- or cluster-randomized trial, an individually randomized group-treatment trial, a stepped-wedge design, or a quasi-experimental version of one of these designs. In these studies, special methods may be warranted for analysis and sample size estimation. Applicants should show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.

Key Dates:

Open Date (Earliest Submission Date): September 25, 2021
Letter of Intent Due Date(s): 30 days prior to application due date
Application Due Dates: October 25, 2021

URL for more information:

https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-22-010.html

Filed Under: Funding Opportunities