Improving Physical Ability and Cellular Senescence Elimination in HIV

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: HIV, Frailty, Prefrail, Aging Problems

In brief

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.

Key facts

Study ID

NCT07144293

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

82

Starts

2025-12-04

Expected to finish

2026-09-01

Last updated by the study team

2026-07-17

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Have used quercetin or dasatinib before.
• 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.
• Have substance use that might interfere with study participation, as determined by the site investigator.
• Have had a significant illness within 60 days before joining the study.

Where it is running

• University of California, Los Angeles CARE Center CRS (Site ID: 601) — Los Angeles, California, United States
• UCSD Antiviral Research Center CRS (Site ID: 701) — San Diego, California, United States
• University of California, San Francisco HIV/AIDS CRS (Site ID: 801) — San Francisco, California, United States
• Harbor University of California Los Angeles Center CRS (Site ID: 603) — Torrance, California, United States
• University of Colorado Hospital CRS (Site ID: 6101) — Aurora, Colorado, United States
• Whitman-Walker Institute, Inc. CRS (Site ID: 31791) — Washington D.C., District of Columbia, United States
• Northwestern University CRS (Site ID: 2701) — Chicago, Illinois, United States
• Massachusetts General Hospital CRS (MGH CRS) (Site ID: 101) — Boston, Massachusetts, United States
• Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS (Site ID: 107) — Boston, Massachusetts, United States
• Washington University Therapeutics (WT) CRS (Site ID: 2101) — St Louis, Missouri, United States
• New Jersey Medical School Clinical Research Center CRS (Site ID: 31786) — Newark, New Jersey, United States
• Weill Cornell Chelsea CRS (Site ID: 7804) — New York, New York, United States
• Columbia Physicians & Surgeons (P&S) CRS (Site ID: 30329) — New York, New York, United States
• Weill Cornell Uptown CRS (Site ID: 7803) — New York, New York, United States
• University of Rochester Adult HIV Therapeutic Strategies Network CRS (Site ID: 31787) — Rochester, New York, United States
• Chapel Hill CRS (Site ID: 3201) — Chapel Hill, North Carolina, United States
• Greensboro CRS (Site ID: 3203) — Greensboro, North Carolina, United States
• Cincinnati CRS (Site ID: 2401) — Cincinnati, Ohio, United States
• Case CRS (Site ID: 2501) — Cleveland, Ohio, United States
• Ohio State University CRS (Site ID: 2301) — Columbus, Ohio, United States
• Penn Therapeutics CRS (Site ID: 6201) — Philadelphia, Pennsylvania, United States
• University of Pittsburgh CRS (Site ID: 1001) — Pittsburgh, Pennsylvania, United States
• Vanderbilt Therapeutics (VT) CRS (Site ID: 3652) — Nashville, Tennessee, United States
• Houston Advancing Research Team CRS (Site ID: 31473) — Houston, Texas, United States
• University of Washington Positive Research CRS (Site ID: 1401) — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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