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

Key Takeaway
Consider D+Q for improving physical function in frail HIV patients pending further results.

This Phase II study evaluates the safety and efficacy of dasatinib and quercetin (D+Q) in improving physical function among individuals aged 50 or older with HIV who are frail or prefrail. The study enrolled 82 participants on stable antiretroviral therapy with viral suppression. Participants were randomized to receive either D+Q or placebo in six cycles over 12 weeks, followed by a 12-week monitoring period. The primary endpoints include the occurrence of Grade 2 or higher adverse events (AEs), premature treatment discontinuations, and changes in gait speed on a 4-meter walk. Although specific statistical outcomes are not yet reported, the study aims to assess whether D+Q can significantly enhance physical function in this population. Secondary endpoints and long-term effects are also under evaluation. Safety data will focus on the incidence of AEs and any treatment-related discontinuations. The results of this trial could inform future therapeutic strategies for managing frailty in older adults living with HIV.

AI Accuracy Review: 9/10 · Auto-published
View Original Abstract ↓
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
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