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Improving Physical Ability and Cellular Senescence Elimination in HIV
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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.
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
82
Start Date
2025-12-04
Completion Date
2026-11-29
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
Dasatinib
Dasatinib will be administered as one 100 mg capsule.
Quercetin
Quercetin will be administered as five 250 mg capsules.
Placebo - Dasatinib
Matching Placebo for Dasatinib will be administered as one 100 mg capsule.
Placebo - Quercetin
Matching Placebo for Quercetin will be administered as five 250 mg capsules.
Locations (27)
Alabama CRS (Site ID: 31788)
Birmingham, Alabama, United States
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
The Ponce de Leon Center CRS (Site ID: 5802)
Atlanta, Georgia, 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