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HIVPhase 2IPACE-HIVNCT07144293

Improving Physical Ability and Cellular Senescence Elimination in HIV

A Phase 2 study testing Dasatinib and Quercetin in people with HIV and Frailty, run by National Institute of Allergy and Infectious Diseases (NIAID) at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
HIV, Frailty, Prefrail
What is being tested?
Dasatinib and Quercetin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
82 participants
Where
24 sitesUnited States
Study dates
4 Dec 2025to 26 Aug 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • University of Colorado Hospital CRS (Site ID: 6101)

    Aurora, Colorado, 80045

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

    Boston, Massachusetts, 02114

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

    Boston, Massachusetts, 02115

  • Chapel Hill CRS (Site ID: 3201)

    Chapel Hill, North Carolina, 27599

  • Cincinnati CRS (Site ID: 2401)

    Cincinnati, Ohio, 45267-0405

  • Case CRS (Site ID: 2501)

    Cleveland, Ohio, 44106

  • Ohio State University CRS (Site ID: 2301)

    Columbus, Ohio, 43210

  • Greensboro CRS (Site ID: 3203)

    Greensboro, North Carolina, 27401

  • Houston Advancing Research Team CRS (Site ID: 31473)

    Houston, Texas, 77030

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

    Los Angeles, California, 90035-4709

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

    Nashville, Tennessee, 37204

  • Weill Cornell Chelsea CRS (Site ID: 7804)

    New York, New York, 10010

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

    New York, New York, 10032

  • Weill Cornell Uptown CRS (Site ID: 7803)

    New York, New York, 10065

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

    Newark, New Jersey, 07103

  • Penn Therapeutics CRS (Site ID: 6201)

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh CRS (Site ID: 1001)

    Pittsburgh, Pennsylvania, 15213

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

    Rochester, New York, 14642

  • UCSD Antiviral Research Center CRS (Site ID: 701)

    San Diego, California, 92103

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

    San Francisco, California, 94143

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

    Seattle, Washington, 98104-9929

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

    St Louis, Missouri, 63110-1010

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

    Torrance, California, 90502

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

    Washington D.C., District of Columbia, 20009

Other trials in United States

About this study

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.

Being tested
Dasatinib, Quercetin, Placebo - Dasatinib, Placebo - Quercetin
Keywords
Frailty, Prefrail, Physical Function, Aging, Senescence, Senolytic therapy
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DasatinibDrug

    Dasatinib will be administered as one 100 mg capsule.

  • QuercetinDrug

    Quercetin will be administered as five 250 mg capsules.

  • Placebo - DasatinibOther

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

  • Placebo - QuercetinOther

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

Study groups in NCT07144293
Study groupRoleWhat they receive
Arm A: D+QExperimentalNot described
Receives: Drug: Dasatinib; Drug: Quercetin
Arm B: PlaceboPlacebo comparatorNot described
Receives: Other: Placebo - Dasatinib; Other: Placebo - Quercetin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 24 weeks

  2. Occurrence of premature treatment discontinuations.

    Measured: 24 weeks

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

    Measured: From Week 0 to Week 12

Secondary outcomes (13)

  1. Absolute change in time to complete 5 chair stands.

    Measured: From Week 0 to Week 12

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

    The Short Performance Physical Battery (SPPB) Total Balance Test scores range from a minimum of 0 to a maximum of 4. Higher scores indicate better balance performance.

    Measured: From Week 0 to Week 12

  3. Absolute change in the SPPB score.

    The SPPB scores range from a minimum of 0 to a maximum of 12. Higher scores indicate better physical performance.

    Measured: From Week 0 to Week 12

  4. Absolute change in 4-meter gait speed.

    Measured: From Week 0 to Week 24

  5. Absolute change in SPPB total balance test score.

    The SPPB Total Balance Test scores range from a minimum of 0 to a maximum of 4. Higher scores indicate better balance performance.

    Measured: From Week 0 to Week 24

  6. Absolute change in SPPB score.

    The SPPB scores range from a minimum of 0 to a maximum of 12. Higher scores indicate better physical performance.

    Measured: From Week 0 to Week 24

  7. Absolute change in timed chair stands.

    Measured: From Week 0 to Week 24

  8. Absolute change in plasma senescence-associated secretory phenotype (SASP) biomarkers.

    Measured: From Week 0 to Weeks 12 and 24

  9. Absolute change in serum SASP biomarkers.

    Measured: From Week 0 to Weeks 12 and 24

  10. Absolute change in cognitive function on the AIDS Clinical Trials Group (ACTG) Neuropsychology Battery "Neuropsychological Battery" section

    Higher scores indicate better cognitive performance.

    Measured: From Week 0 to Weeks 12 and 24

  11. Absolute change in symptoms of anxiety and depression using the Patient Health Questionnaire-9 (PHQ-9) assessments

    The PHQ-9 scores range from a minimum of 0 to a maximum of 27. Lower scores indicate better mental health, while higher scores indicate more severe depression.

    Measured: From Week 0 to Weeks 12 and 24

  12. Absolute change in Veterans Aging Cohort Study (VACS) Index 2.0.

    The VACS Index 2.0 scores range from a minimum of 0 to a maximum of 164. Higher scores indicate a higher risk of mortality and worse health outcomes.

    Measured: From Week 0 to Weeks 12 and 24

  13. Absolute change in participant-reported Quality of Life (QoL) on the Patient-Reported Outcomes Measurement Information System (PROMIS) QoL measure

    The PROMIS QoL measure have no fixed minimum score, but scores can theoretically go as low as 0 and no fixed maximum score, but scores can theoretically go as high as 100. Higher scores indicate better quality of life.

    Measured: From Week 0 to Weeks 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2025
  2. Study start4 Dec 2025
  3. Primary completion26 Aug 2026
  4. Study completion26 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07144293
Sponsor's protocol ID
A5426
Acronym
IPACE-HIV
Status last verified
Sep 2026
First submitted
20 Aug 2025
Last updated
15 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie results in the publication, after deidentification.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dasatinib and Quercetin in people with HIV and Frailty, run by National Institute of Allergy and Infectious Diseases (NIAID) at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Grade 2 or higher adverse events (AEs) after initiation of study treatment. (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07144293.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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IPACE-HIV Clinical Trial NCT07144293 | AzTrials