A5426 Improving Physical Ability and Cellular Senescence Elimination in HIV

HIV comorbidities and complications

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 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.

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.

People with HIV aged 50 years or more who were diagnosed with HIV 10 or more years ago, who are currently on combination antiretroviral therapy (ART) and are currently virally suppressed (<50 copies/mL at screening). All participants must meet at least one Fried Frailty Phenotype (FFP) criteria [Fried 2001] and have an average gait speed in the range of 0.5-1.2 meters/second on the 4-meter walk test.

Randomization will be stratified by sex and age category (50-59 vs ≥60 years old)

Intervention: Six consecutive 2-week cycles consisting of two days of D+Q (dasatinib [100 mg/day] plus quercetin [1250 mg/day] by mouth for 2 days or matching placebos identical to D+Q followed by 12 days without intervention (total number of doses = 12).

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.