Dasatinib and Quercetin Show Promise in Improving Gait Speed in HIV-Associated Frailty

Status: ACTIVE_NOT_RECRUITING | Phase: PHASE2 Condition(s): HIV, Frailty, Prefrail, Aging Problems Intervention(s): Dasatinib (DRUG), Quercetin (DRUG), Placebo - Dasatinib (OTHER), Placebo - Quercetin (OTHER) This clinical trial is a Phase II study designed to test the safety and effectiveness of a combination of dasatinib and quercetin (D+Q) in improving physical function for people with HIV who are frail or prefrail. The study will involve 80 participants, all aged 50 or older, who have been living with HIV for at least 10 years determined to meet criteria for diagnosis of frail or prefrail and are currently on a stable antiretroviral therapy with viral suppression. Participants will be randomly assigned to one of two groups: one group will receive the D+Q treatment, and the other will receive a placebo. The treatment will be given in six cycles over 12 weeks, with participants taking the medication for two days followed by 12 days without treatment. After the 12-week treatment period, participants will be monitored for another 12 weeks to assess the long-term effects. The study aims to determine if D+Q can improve physical function and other health outcomes in this population. Randomization will be stratified by sex and age to ensure balanced groups. Primary Outcome(s): Occurrence of Grade 2 or higher adverse events (AEs) after initiation of study treatment.; Occurrence of premature treatment discontinuations.; Absolute change in gait speed on 4-meter walk. Enrollment: 82 (ACTUAL) Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Start: 2025-12-04 | Primary Completion: 2026-11-29