RecruitingPhase 2NCT07144293

Improving Physical Ability and Cellular Senescence Elimination in HIV


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

80 participants

Start Date

Dec 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of two drugs — quercetin and dasatinib — can eliminate aging "zombie" cells (called senescent cells) and improve physical function in older adults living with HIV. Removing these cells may reduce inflammation and slow the effects of aging in people with HIV. **You may be eligible if...** - You are 50 years or older with a confirmed HIV-1 diagnosis - You were diagnosed with HIV at least 10 years ago - You have been on stable antiretroviral therapy with well-controlled HIV (very low viral levels) - You show at least one sign of physical frailty (e.g., slow walking speed, low grip strength, exhaustion, low activity, or unintentional weight loss) - Your kidney function is adequate **You may NOT be eligible if...** - You have previously taken quercetin or dasatinib - You take medications that interact with dasatinib or affect CYP3A4 enzymes (certain HIV drugs may apply) - You have active cancer (other than non-melanoma skin cancer) - You have active liver disease or significant liver problems - You are on dialysis or have had a kidney transplant - You had a heart attack, stroke, or serious heart event in the past 6 months - You have poorly controlled diabetes (HbA1c above 8%) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDasatinib

Dasatinib will be administered as one 100 mg capsule.

DRUGQuercetin

Quercetin will be administered as five 250 mg capsules.

OTHERPlacebo - Dasatinib

Matching Placebo for Dasatinib will be administered as one 100 mg capsule.

OTHERPlacebo - Quercetin

Matching Placebo for Quercetin will be administered as five 250 mg capsules.


Locations(27)

Weill Cornell Uptown CRS (Site ID: 7803)

New York, New York, United States

Northwestern University CRS (Site ID: 2701)

Chicago, Illinois, United States

The Ponce de Leon Center CRS (Site ID: 5802)

Atlanta, Georgia, United States

Alabama CRS (Site ID: 31788)

Birmingham, Alabama, United States

Harbor University of California Los Angeles Center CRS (Site ID: 603)

Torrance, California, United States

Whitman-Walker Institute, Inc. CRS (Site ID: 31791)

Washington D.C., District of Columbia, United States

UCSD Antiviral Research Center CRS (Site ID: 701)

San Diego, California, United States

University of Colorado Hospital CRS (Site ID: 6101)

Aurora, Colorado, United States

University of California, Los Angeles CARE Center CRS (Site ID: 601)

Los Angeles, California, United States

University of California, San Francisco HIV/AIDS CRS (Site ID: 801)

San Francisco, California, United States

Washington University Therapeutics (WT) CRS (Site ID: 2101)

St Louis, Missouri, United States

Chapel Hill CRS (Site ID: 3201)

Chapel Hill, North Carolina, United States

Weill Cornell Chelsea CRS (Site ID: 7804)

New York, New York, United States

Greensboro CRS (Site ID: 3203)

Greensboro, North Carolina, United States

Columbia Physicians & Surgeons (P&S) CRS (Site ID: 30329)

New York, New York, United States

Penn Therapeutics CRS (Site ID: 6201)

Philadelphia, 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

Cincinnati CRS (Site ID: 2401)

Cincinnati, Ohio, United States

Ohio State University CRS (Site ID: 2301)

Columbus, Ohio, United States

University of Rochester Adult HIV Therapeutic Strategies Network CRS (Site ID: 31787)

Rochester, New York, United States

University of Washington Positive Research CRS (Site ID: 1401)

Seattle, Washington, United States

University of Pittsburgh CRS (Site ID: 1001)

Pittsburgh, Pennsylvania, United States

Case CRS (Site ID: 2501)

Cleveland, Ohio, United States

New Jersey Medical School Clinical Research Center CRS (Site ID: 31786)

Newark, New Jersey, 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

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NCT07144293


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