Dasatinib for HIV Infection

Not yet recruiting at 2 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Must be taking: Antiretrovirals

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with HIV who've been on ART for at least 48 months and maintained an undetectable viral load for over 36 months. They should have normal blood cell counts, liver function tests within certain limits, and a CD4+ count above 450 cells/mm3.

Inclusion Criteria

I am infected with HIV-1.
My HIV-1 levels are undetectable as of the last 3 months.
My total bilirubin levels are within normal limits.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to take dasatinib 100 mg or placebo once a day for 12 weeks

12 weeks
Regular health checks and blood tests

Follow-up

Participants are monitored for safety, tolerability, and changes in the HIV reservoir and immune cells

24 weeks
Clinic visits and possible phone calls

What Are the Treatments Tested in This Trial?

Interventions

  • Dasatinib

Trial Overview

The study is testing dasatinib to see if it can reduce the hidden HIV 'reservoir' in the body. Participants will either take dasatinib or a placebo without knowing which one they're getting (double-blind) for 12 weeks, followed by a monitoring period of another 24 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 1: dasatinibExperimental Treatment1 Intervention
Group II: Arm 2: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+