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Active, Not Recruiting

NCT Number: NCT07144293

Improving Physical Ability and Cellular Senescence Elimination in HIV

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV Aging Problems Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms Prefrail

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

dasatinib

Drug

Dasatinib will be administered as one 100 mg capsule.

Quercetin

Drug

Quercetin will be administered as five 250 mg capsules.

Placebo - Dasatinib

Other

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

Placebo - Quercetin

Other

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

Primary outcomes

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

    Time frame: 24 weeks

  2. Occurrence of premature treatment discontinuations.

    Time frame: 24 weeks

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

    Time frame: From Week 0 to Week 12

Secondary outcomes

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

    Time frame: From Week 0 to Week 12

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

    Time frame: From Week 0 to Week 12

    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.

  3. Absolute change in the SPPB score.

    Time frame: From Week 0 to Week 12

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

  4. Absolute change in 4-meter gait speed.

    Time frame: From Week 0 to Week 24

  5. Absolute change in SPPB total balance test score.

    Time frame: From Week 0 to Week 24

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

  6. Absolute change in SPPB score.

    Time frame: From Week 0 to Week 24

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

  7. Absolute change in timed chair stands.

    Time frame: From Week 0 to Week 24

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

    Time frame: From Week 0 to Weeks 12 and 24

  9. Absolute change in serum SASP biomarkers.

    Time frame: 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

    Time frame: From Week 0 to Weeks 12 and 24

    Higher scores indicate better cognitive performance.

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

    Time frame: From Week 0 to Weeks 12 and 24

    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.

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

    Time frame: From Week 0 to Weeks 12 and 24

    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.

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

    Time frame: From Week 0 to Weeks 12 and 24

    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.

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: IPACE-HIV

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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