NIH Grants

NIAID’s new notice of funding opportunity (NOFO) Strategies for Controlled Release of HIV Vaccines (SCORE-H) (R01, Clinical Trial Not Allowed) supports research to advance controlled-release strategies for HIV vaccines that aim to elicit protective and durable broadly neutralizing responses and antiviral T-cell/innate responses.

The goal of this Notice of Funding Opportunity (NOFO) is to support development of LADDS for optimized treatment of HIV-1 in children. This initiative will stimulate the optimization and evaluation of LADDS formulations in suitable preclinical animal models, at an earlier stage of adult drug development. Supporting optimization and evaluation of LADDS formulations in suitable preclinical animal models could accelerate clinical translation in pediatric populations and improve HIV-1 treatment outcomes in children.

The purpose of this Notice of Funding Opportunity (NOFO) is to support the development of a comprehensive and well-defined product development strategy for next-generation treatments for HIV and HIV-associated comorbidities, coinfections and complications and preventive strategies for HIV, as well as facilitating the translation of research findings into drug products that enables submission of an Investigational New Drug (IND) application to the FDA.

Clinical experience for HIV treatment and prevention has demonstrated that adherence to a drug regimen schedule is a significant factor in the success of the HIV treatment regime and/or prevention strategies. Effective treatment of HIV-infected individuals requires strict adherence to a multi-component regimen of antiretroviral agents taken at least daily for the remainder of a patient’s life. Non-adherence can lead to emergence of drug-resistance and loss of therapeutic effectiveness. Among people living with HIV, morbidity and mortality is increasingly driven by co-infections, such as tuberculosis (TB) and hepatitis B, where the compliance and completion of prolonged multidrug regimens are significant factors in treatment success.

Effective prevention requires that the inhibitor be present at the right time, place, and concentration to stop HIV transmission and acquisition. Although many factors (social, behavioral, and individual preference) can influence adherence, the use of drug delivery systems to provide for a longer therapeutic exposure or window of protection and/or less frequent administration may improve their consistent use, reduce dosing intervals, and potentially improve adherence to the drug regimens.

Development of safe, effective, and well-tolerated sustained release (SR)/long acting (LA) products and strategies that maintain consistent and effective drug levels in plasma and target tissues for longer periods of time is critical for successful treatment and prevention of HIV and HIV-associated co-infections.