Federal Project Grant Award Summary

The National Institute of Allergy and Infectious Diseases (NIAID) awarded The Regents of the University of California, San Francisco a Project Grant totaling $772,342 (Award Date: May 6, 2026; Completion Date: April 30, 2031) under the Allergy and Infectious Diseases Research program (CFDA 93.855). This research initiative, titled "Strategies to Predict Success on Long-Acting Therapy in Real-World Settings for HIV (SPLASH)," investigates the clinical efficacy and pharmacokinetic (PK) mechanisms underlying long-acting antiretroviral therapy (LA ART) in real-world patient populations not well-represented in traditional clinical trials, particularly those with initial viremia and adherence challenges.

The research will be conducted through a collaborative cohort study involving UCSF Ward 86 Clinic in San Francisco and Emory's Ponce de Leon Clinic in Atlanta, which collectively maintain approximately 1,100 patients on LA ART—the two largest such programs in the United States. The project deliverables include: establishing relationships between specific threshold drug concentrations of cabotegravir, rilpivirine, and lenacapavir in plasma and hair samples with virologic outcomes; identifying patient-level factors (body mass index, age, sex) that modify treatment response; and conducting deep investigation into how LA ART affects active and latent viral reservoirs to address concerns regarding viral blips and incomplete viral suppression. This research will generate evidence to inform clinical practice guidelines and improve treatment outcomes for people with HIV in routine clinical settings.