Dasatinib for HIV-1 Reservoir Reduction
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study ID
- NCT07342491
- Phase
- PHASE1
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dasatinib — DRUGwill be administered as one 100 mg capsule (over-encapsulated tablet) orally once daily for 12 weeks
- Placebo — OTHERPlacebo for dasatinib will be administered as one placebo capsule (over-encapsulated tablet) orally once daily for 12 weeks
Study Details
This study will test if the medicine dasatinib can lower the hidden amount of HIV in the body, called the HIV "reservoir." It will also check if dasatinib is safe and easy to take for people living with HIV who have a suppressed viral load while on antiretroviral therapy (ART). Adults 18 years or older who have been on ART for at least 48 months and have had a suppressed HIV-1 viral load for at least 36 months may be able to join. People will be randomly assigned to take dasatinib 100 mg by mouth once a day or a look-alike substance with no drug, called a placebo, for 12 weeks. Neither participants nor researchers will know who gets which (double-blind). The study team will do regular health checks and blood tests to track safety, tolerability, the HIV reservoir, and changes in immune cells. The study lasts 36 weeks total: 12 weeks of treatment and 24 weeks of follow-up, with clinic visits and possible phone calls. Fourteen people will take part; eight will get dasatinib and six will get placebo. Dasatinib may lower the HIV reservoir, but this is not guaranteed. All medicines can cause side effects, called adverse events (AE). The study team will watch closely and provide medical support. Joining is your choice, and you can leave at any time. If you leave, the team will talk with you about next steps for your care.
Key Dates
- Start date
- May 8, 2026
- Status verified
- Jun 2026
- Primary completion
- Nov 25, 2026
- Completion
- May 12, 2027
Study Design
- Enrollment
- 14 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm 1: dasatinib100 mg by mouth daily
- Placebo Comparator: Arm 2: PlaceboPlacebo for dasatinib
Primary Outcome Measure
Change in intact HIV-1 reservoir size [ Time Frame: Baseline and week 12 ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Northwestern University CRS (Site # 2701) | Chicago | Illinois | 60611 | |
| 2501, Case CRS | Cleveland | Ohio | 44106 | |
| 1401, University of Washington Positive Research CRS | Seattle | Washington | 98104 |
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