Status:
NOT_YET_RECRUITING
Improving Physical Ability and Cellular Senescence Elimination in HIV
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
HIV
Frailty
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 29 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07144293
Start Date
October 15 2025
End Date
November 29 2026
Last Update
September 25 2025
Active Locations (27)
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1
Alabama CRS (Site ID: 31788)
Birmingham, Alabama, United States, 35222
2
University of California, Los Angeles CARE Center CRS (Site ID: 601)
Los Angeles, California, United States, 90035-4709
3
UCSD Antiviral Research Center CRS (Site ID: 701)
San Diego, California, United States, 92103
4
University of California, San Francisco HIV/AIDS CRS (Site ID: 801)
San Francisco, California, United States, 94143