Improving Physical Ability and Cellular Senescence Elimination in HIV

NCT07144293 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: A5426
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 27

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 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.

Conditions

HIV; Frailty; Prefrail; Aging Problems

Keywords

Frailty; Prefrail; Physical Function; Aging; Senescence; Senolytic therapy

Outcome Measures

Primary Outcomes (3)

• Occurrence of Grade 2 or higher adverse events (AEs) after initiation of study treatment.

  24 weeks

• Occurrence of premature treatment discontinuations.

  24 weeks

• Absolute change in gait speed on 4-meter walk.

  From Week 0 to Week 12

Secondary Outcomes (13)

• Absolute change in time to complete 5 chair stands.

  From Week 0 to Week 12

• Absolute change in Short Performance Physical Battery (SPPB) Total Balance Test score.

  From Week 0 to Week 12

• Absolute change in the SPPB score.

  From Week 0 to Week 12

• Absolute change in 4-meter gait speed.

  From Week 0 to Week 24

• Absolute change in SPPB total balance test score.

  From Week 0 to Week 24

Study Arms (2)

Arm A: D+Q

EXPERIMENTAL

Drug: Dasatinib; Drug: Quercetin

Arm B: Placebo

PLACEBO COMPARATOR

Other: Placebo - Dasatinib; Other: Placebo - Quercetin

Interventions

Dasatinib DRUG

Dasatinib will be administered as one 100 mg capsule.

Arm A: D+Q

Quercetin DRUG

Quercetin will be administered as five 250 mg capsules.

Arm A: D+Q

Placebo - Dasatinib OTHER

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

Arm B: Placebo

Placebo - Quercetin OTHER

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

Arm B: Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (27)

Alabama CRS (Site ID: 31788)

Birmingham, Alabama, 35222, United States

Location

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

Los Angeles, California, 90035-4709, United States

Location

UCSD Antiviral Research Center CRS (Site ID: 701)

San Diego, California, 92103, United States

Location

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

San Francisco, California, 94143, United States

Location

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

Torrance, California, 90502, United States

Location

University of Colorado Hospital CRS (Site ID: 6101)

Aurora, Colorado, 80045, United States

Location

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

Washington D.C., District of Columbia, 20009, United States

Location

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

Atlanta, Georgia, 30308-2012, United States

Location

Northwestern University CRS (Site ID: 2701)

Chicago, Illinois, 60611, United States

Location

Massachusetts General Hospital CRS (MGH CRS) (Site ID: 101)

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS (Site ID: 107)

Boston, Massachusetts, 02115, United States

Location

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

St Louis, Missouri, 63110-1010, United States

Location

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

Newark, New Jersey, 07103, United States

Location

Weill Cornell Chelsea CRS (Site ID: 7804)

New York, New York, 10010, United States

Location

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

New York, New York, 10032, United States

Location

Weill Cornell Uptown CRS (Site ID: 7803)

New York, New York, 10065, United States

Location

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

Rochester, New York, 14642, United States

Location

Chapel Hill CRS (Site ID: 3201)

Chapel Hill, North Carolina, 27599, United States

Location

Greensboro CRS (Site ID: 3203)

Greensboro, North Carolina, 27401, United States

Location

Cincinnati CRS (Site ID: 2401)

Cincinnati, Ohio, 45267-0405, United States

Location

Case CRS (Site ID: 2501)

Cleveland, Ohio, 44106, United States

Location

Ohio State University CRS (Site ID: 2301)

Columbus, Ohio, 43210, United States

Location

Penn Therapeutics CRS (Site ID: 6201)

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh CRS (Site ID: 1001)

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt Therapeutics (VT) CRS (Site ID: 3652)

Nashville, Tennessee, 37204, United States

Location

Houston Advancing Research Team CRS (Site ID: 31473)

Houston, Texas, 77030, United States

Location

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

Seattle, Washington, 98104-9929, United States

Location

MeSH Terms

Conditions

Frailty

Interventions

Dasatinib; Quercetin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): November 29, 2026
• Study Completion (Estimated): November 29, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months following publication and available throughout period of funding of the ACTG (Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections) by NIH.
• Access Criteria: * With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the ACTG (Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections). * For what types of analyses? To achieve aims in the proposal approved by the ACTG. * By what mechanism will data be made available? Researchers may submit a request for access to data using the ACTG "Data Request" form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an ACTG Data Use Agreement before receiving the data.

Locations

US (27)