Improving Physical Ability and Cellular Senescence Elimination in HIV (NCT07144293) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Improving Physical Ability and Cellular Senescence Elimination in HIV
United States82 participantsStarted 2025-12-04
Plain-language summary
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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Must be an older person with confirmed diagnosis of HIV-1, defined as ≥ 50 years at study entry.
. Must have been diagnosed with HIV at least 10 years ago, as confirmed by medical records or self-report.
. Must be on a stable effective combination antiretroviral therapy (ART) regimen, with no changes in the regimen within 12 weeks before joining the study with 2 or more consecutive HIV-RNA levels \< 50 copies/mL within 48 weeks prior to study entry.
. Must meet one or more Fried Frailty Phenotype criteria w/in 60 days prior to entry.
. Must have eGFR \> 30 using CKD-EPI per 2021 calculation equation.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of Grade 2 or higher adverse events (AEs) after initiation of study treatment.
Timeframe: 24 weeks
2
Occurrence of premature treatment discontinuations.
Timeframe: 24 weeks
3
Absolute change in gait speed on 4-meter walk.
Timeframe: From Week 0 to Week 12
Trial details
NCT IDNCT07144293
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Need to take medications that affect CYP3A4 or interact with dasatinib (e.g., certain HIV medications).
. Have an active cancer (except non-melanoma skin cancer).
. Have active liver disease with a Child Pugh score greater than 6, or other significant liver problems.
. Are on dialysis or have had a kidney transplant.
. Have had a heart attack, angina, stroke, or mini-stroke in the last 6 months.
. Have a known history of pulmonary arterial hypertension or other respiratory disease requiring supplemental oxygen within 60 days before joining the study.
. Have uncontrolled diabetes with an HgbA1c level greater than 8% within 60 days before joining the study.