Therapeutics Development for HIV/AIDS Associated Neuropsychological Disorders (STTRR41/R42) | Apply Online

Opportunity Summary:

Therapeutics Development for HIV/AIDS Associated Neuropsychological Disorders (STTR R41/R42), Funding Opportunity Number PA-06-433, is a National Institutes of Health grant opportunity that targets the development of treatments for the mental and neurological complications associated with HIV/AIDS. Led by interests within the NIMH Center for Mental Health Research on AIDS (CMHRA) and the National Institute on Drug Abuse (NIDA), the program focuses on translating promising science into therapeutic products and enabling technologies that can address central nervous system (CNS) involvement in HIV, including cognitive, behavioral, and neurological impairments that persist even in the era of antiretroviral therapy.

A major scientific emphasis of the announcement is on innovations that can directly or indirectly eliminate or reduce HIV reservoirs in the brain. Applicants are encouraged to pursue novel therapeutic agents, therapeutic approaches, biomarkers, and drug delivery technologies that improve CNS targeting or help overcome barriers to effective treatment in the brain. The FOA also welcomes the creation of new assays and experimental models that make it easier to measure neurotoxicity, quantify treatment impact, and screen candidate therapies more efficiently. This includes both in vitro and in vivo model systems that better reflect HIV-related CNS disease and can be used to identify and validate drug candidates.

In addition to therapies aimed at viral persistence and HIV-driven neuropathology, the FOA explicitly supports work on interventions that protect against, reduce, or treat long-term side effects of antiretroviral drugs. This is framed broadly to reflect real-world clinical complexity, including situations where antiretroviral treatment overlaps with psychotropic medications, drugs of abuse, or medications used to treat substance use disorders. The announcement also highlights a strong interest in adjunctive therapies that address the consequences of HIV in the CNS when HIV co-occurs with mental illness or drug addiction, recognizing that comorbidity can worsen outcomes and complicate care.

The funding mechanism is the Small Business Technology Transfer (STTR) program using the R41 (Phase I) and R42 (Phase II) awards, with the option to apply through a Fast Track pathway that links Phase I and Phase II in a streamlined application strategy. Phase I budgets may request up to $250,000 in total costs per year for project periods up to 2 years, supporting feasibility and early proof-of-concept development. Phase II budgets may request up to $450,000 in total costs per year for project periods up to 3 years, supporting more advanced development activities such as optimization, expanded preclinical testing, validation in stronger models, and other steps needed to move a therapeutic concept toward commercialization or later-stage development. Importantly, the NIH did not set aside a fixed amount of money for this FOA; the number of awards and total funding are not predetermined and depend on application quality and available funds.

Eligibility is limited to U.S. small business concerns; foreign institutions are not eligible to apply. Because this is an STTR opportunity, the project must be conducted through a formal collaboration between the small business and a single nonprofit research institution, with required minimum levels of effort: at least 40% of the work must be performed by the small business and at least 30% by the partnering research institution. These percentages are calculated based on the total of direct and indirect (F&A) costs attributable to each party, unless a different approach is explicitly described and justified in the application. The Project Director/Principal Investigator may be primarily employed either by the small business or by the partnering nonprofit research institution, as long as there is a formal appointment or commitment establishing an official relationship with the applicant small business.

From an application volume standpoint, a small business may submit more than one application as long as each is scientifically distinct. At the same time, NIH will not accept multiple submissions from the same organization that are essentially the same project with minor, non-substantive variations, particularly when they amount to repackaging a single product for multiple uses. Applicants also cannot submit identical or essentially identical applications under this FOA and another HHS funding opportunity simultaneously, including the Parent SBIR or STTR announcements. The FOA runs in parallel with a companion SBIR announcement of identical scientific scope (PA-06-432) that uses the SBIR R43/R44 mechanisms, offering a route for eligible small businesses that prefer SBIR rather than STTR.

Administrative details reflect that this was a discretionary grant opportunity within NIH health and research programs (including CFDA 93.242 and 93.279), with no cost sharing requirement. The opportunity originally posted in 2006 and used multiple receipt dates, with the final listed closing date in January 2010 and an archive date in February 2010. The full announcement was hosted through the NIH Grants Guide (PA-06-433), and NIH provided general contact support through the Office of Extramural Research for access and linking issues.

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Next opportunity: Therapeutics Development for HIV/AIDS Associated Neuropsychological Disorders (SBIRR43/R44)

Previous opportunity: Novel Tools for Investigating Brain derived GPCRs in Mental Health Research (SBIR R43/R44)

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