Trials / Active Not Recruiting
Active Not RecruitingNCT07144293
Improving Physical Ability and Cellular Senescence Elimination in HIV
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 82 (actual)
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID) · NIH
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dasatinib | Dasatinib will be administered as one 100 mg capsule. |
| DRUG | Quercetin | Quercetin will be administered as five 250 mg capsules. |
| OTHER | Placebo - Dasatinib | Matching Placebo for Dasatinib will be administered as one 100 mg capsule. |
| OTHER | Placebo - Quercetin | Matching Placebo for Quercetin will be administered as five 250 mg capsules. |
Timeline
- Start date
- 2025-12-04
- Primary completion
- 2026-11-29
- Completion
- 2026-11-29
- First posted
- 2025-08-27
- Last updated
- 2026-03-24
Locations
27 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07144293. Inclusion in this directory is not an endorsement.