Pilot Clinical Trials Targeting HIV-1 Reservoirs in Children (U01) | RFA AI 16 086

Opportunity Information: Apply for RFA AI 16 086

Pilot Clinical Trials Targeting HIV-1 Reservoirs in Children (U01), Funding Opportunity Number RFA-AI-16-086, is a National Institutes of Health (NIH) discretionary funding opportunity designed to move pediatric HIV cure-related research into early, real-world testing. The focus is on supporting pilot clinical trials that evaluate interventions intended to limit, shrink, or otherwise reduce HIV-1 reservoirs in children and adolescents. In this context, "reservoirs" refers to persistent HIV-infected cells and tissues that remain in the body even when standard antiretroviral therapy (ART) suppresses the virus in the blood, representing the main barrier to long-term remission or cure. The trials supported under this announcement are specifically for participants from birth through 18 years of age at the time of enrollment who are already on effective, suppressive ART, meaning the target population is clinically stable on treatment while still carrying residual virus that current drugs do not eliminate.

The mechanism is a U01 cooperative agreement, which generally indicates that NIH expects substantial scientific or programmatic involvement during the course of the project, beyond the typical oversight used in standard research grants. This structure is commonly used when an agency wants to work closely with awardees on study design, milestones, trial conduct, and coordination, especially for complex or high-priority clinical research areas such as HIV reservoir reduction strategies in pediatric populations. The funding activity category is Health, and the associated CFDA numbers are 93.855 and 93.856, which correspond to NIH HIV/AIDS-related research programs.

The opportunity is open to a broad range of applicant organizations, reflecting an intent to encourage diverse clinical and research settings capable of conducting pediatric HIV trials. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those two nonprofit categories); for-profit organizations other than small businesses; small businesses; Native American tribal governments (federally recognized); public housing authorities/Indian housing authorities; and Native American tribal organizations other than federally recognized tribal governments. The FOA also explicitly highlights additional eligible applicant types, including Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible federal agencies; U.S. territories or possessions; regional organizations; Indian/Native American tribal governments other than federally recognized; and non-domestic (non-U.S.) entities (foreign organizations). This wide eligibility list signals an emphasis on engaging institutions and communities that may serve populations disproportionately affected by HIV or that have specialized pediatric clinical infrastructure.

Key dates and administrative details in the source information indicate the FOA was created on 2016-12-05 and had an original closing date of 2017-03-14. The listing does not provide an award ceiling or expected number of awards in the provided excerpt, suggesting those details were either not specified in the snippet or were defined elsewhere in the full announcement.

Overall, this FOA is best understood as an NIH effort to catalyze early-stage, intervention-focused clinical trials aimed at the hardest part of HIV cure science in children: addressing the persistent HIV-1 reservoir despite successful ART. By funding pilot trials under a cooperative agreement model and allowing applications from a wide variety of domestic and international institutions, the program aims to generate practical clinical evidence about strategies that could eventually contribute to durable remission or cure approaches tailored specifically to pediatric and adolescent patients.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pilot Clinical Trials Targeting HIV-1 Reservoirs in Children (U01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855, 93.856.
• This funding opportunity was created on 2016-12-05.
• Applicants must submit their applications by 2017-03-14. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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