Long-acting Drug Delivery Systems for ART Optimization in HIV-1 Infected Children (R61/R33 Clinical Trial Not Allowed)

End Date: 
Mar 13 2019
Grant Type: 
Grant Source: 

DEADLINE: 13 MAR 2019 - 5:00 PM local time of applicant

The purpose of this Funding Opportunity Announcement (FOA) is to accelerate development of safe and effective long-acting drug delivery systems (LA-DDS) for improved, simplified treatment of HIV-1 in children. This FOA invites applicants engaged in the development of existing LA-DDS platforms at early product development stages to perform specific preclinical activities that enable product optimization and accelerated translation to HIV-1 infected children. Collaborative research partnerships with industry are required.

Research Objectives and Scope
The objective is to develop a LA-DDS for treating HIV-1 in one or more pediatric age groups. For the purposes of this FOA, the target pediatric age groups are defined as: infants (0-< 2 years), young children (2-< 6 years), older children (6-< 12 years) and adolescents (12-< 18 years). While all pediatric populations are of interest, recent FDA draft guidance encouraging adolescent inclusion in adult studies of antiviral agents, could mean easier transition for these products to adolescents or older children where, limited or no formulation optimization activity may be required, compared to younger children. Therefore, additional emphasis in this FOA is placed in non-adolescent (infants and children) age groups, particularly infants. The proposed LA-DDS may be in preclinical testing or early human clinical testing phase (up to phase 2) in adults but should not have undergone any clinical testing or have imminent plans for such testing in pediatric populations for anti-HIV-1 indications.