A Phase 2 interventional study of Dasatinib and Quercetin in HIV, Frailty and Prefrail, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 24 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment
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.
1,199 studies on the registry are indexed under Frailty; 430 are open to participants now.
This study's enrollment of 82 is close to the median of 80 across 681 interventional studies indexed under Frailty.
Browse Frailty studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Dasatinib · Drug: Quercetin
Other: Placebo - Dasatinib · Other: Placebo - Quercetin
Dasatinib will be administered as one 100 mg capsule.
Quercetin will be administered as five 250 mg capsules.
Matching Placebo for Dasatinib will be administered as one 100 mg capsule.
Matching Placebo for Quercetin will be administered as five 250 mg capsules.
Occurrence of Grade 2 or higher adverse events (AEs) after initiation of study treatment.
Time frame: 24 weeks
Occurrence of premature treatment discontinuations.
Time frame: 24 weeks
Absolute change in gait speed on 4-meter walk.
Time frame: From Week 0 to Week 12
Absolute change in time to complete 5 chair stands.
Time frame: From Week 0 to Week 12
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.
Time frame: From Week 0 to Week 12
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.
Time frame: From Week 0 to Week 12
Absolute change in 4-meter gait speed.
Time frame: From Week 0 to Week 24
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.
Time frame: From Week 0 to Week 24
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.
Time frame: From Week 0 to Week 24
Absolute change in timed chair stands.
Time frame: From Week 0 to Week 24
Absolute change in plasma senescence-associated secretory phenotype (SASP) biomarkers.
Time frame: From Week 0 to Weeks 12 and 24
Absolute change in serum SASP biomarkers.
Time frame: From Week 0 to Weeks 12 and 24
Absolute change in cognitive function on the AIDS Clinical Trials Group (ACTG) Neuropsychology Battery "Neuropsychological Battery" section
Higher scores indicate better cognitive performance.
Time frame: From Week 0 to Weeks 12 and 24
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.
Time frame: From Week 0 to Weeks 12 and 24
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.
Time frame: From Week 0 to Weeks 12 and 24
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.
Time frame: From Week 0 to Weeks 12 and 24
Plan to share: Yes — Individual participant data that underlie results in the publication, after deidentification.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)