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

Must not be taking: Anticoagulants, Antiplatelets, Immunomodulators, others

Disqualifiers: Pregnancy, Hepatic impairment, Active malignancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether dasatinib, a type of medication, can reduce the hidden amount of HIV in the body, known as the HIV "reservoir," and whether it is safe and easy to take for those living with HIV. Participants will take either dasatinib or a placebo (a look-alike pill with no active drug) to observe the effects on their HIV status. This trial is for individuals who have been on consistent HIV treatment for over four years and have maintained a suppressed viral load for at least three years. Regular health checks and blood tests will monitor progress and safety. As a Phase 1 trial, the research focuses on understanding how dasatinib works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial requires participants to continue their current antiretroviral therapy (ART) throughout the study. However, you cannot participate if you are using certain medications, like those that affect the heart's rhythm or interact with dasatinib. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that dasatinib is likely to be safe for humans?

Research has shown that dasatinib, a drug tested for reducing hidden HIV in the body, has been safe and well-tolerated in past studies. In one study, participants with HIV took a daily dose of 70 mg for 24 weeks and generally tolerated the treatment well. There were no major safety issues, and the drug did not cause serious side effects. This suggests that dasatinib, even at a slightly higher daily dose of 100 mg, may be safe for participants in the current study. However, like any medication, it might cause some side effects, and the study team will closely monitor participants to ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for HIV focus on targeting the virus itself, using antiretroviral therapies to stop it from multiplying. But dasatinib works differently. It’s a cancer drug originally used for leukemia, and researchers are curious about its potential to modulate the immune system in people with HIV. This unique approach could offer a new way to manage HIV by enhancing the body's immune response, rather than just targeting the virus. This novel mechanism is what makes dasatinib stand out and why researchers are eager to explore its possibilities.

What evidence suggests that dasatinib might be an effective treatment for HIV?

Research shows that dasatinib, which participants in this trial may receive, might help reduce the hidden amount of HIV in the body, known as the HIV reservoir. Previous case studies found it more effective than other treatments at shrinking this reservoir in people with HIV. Dasatinib interferes with HIV's ability to persist in the body and makes immune cells less likely to become infected. This means dasatinib could support current treatments by making it harder for the virus to remain. Early evidence also suggests it may help reduce ongoing immune activation, where the immune system remains overactive due to HIV. ^{1 4 6 7 8}

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.

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?

Group I: Arm 1: dasatinib Experimental Treatment 1 Intervention

100 mg by mouth daily

Group II: Arm 2: Placebo Placebo Group 1 Intervention

Placebo for dasatinib

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S0006295224004957

Dasatinib interferes with HIV-1 proviral integration and the ...

Dasatinib is very efficient at interfering with HIV-1 infection of CD4 + T cells by preserving the antiviral activity of SAMHD1.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05780073

NCT05780073 | Safety and Impact of Dasatinib on Viral ...

Dasatinib will interfere with HIV-1 persistence mechanisms contributing to chronic immune activation and inflammation status in both concordant and immune- ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10055786/

Immunomodulatory Activity of the Tyrosine Kinase Inhibitor ...

Quite unexpectedly, CD4+ T cells from CML individuals under dasatinib therapy were shown to be resistant to ex vivo HIV-1 infection [88,90].

4.

amfar.org

amfar.org/press-releases/amfar-greenlights-new-hiv-cure-studies-with-grants-totaling-1-2-million/

amfAR Greenlights New HIV Cure Studies with Grants ...

Previous case studies have shown it to be more effective than other treatments at reducing the size of the reservoir in people living with HIV.

5.

tandfonline.com

tandfonline.com/doi/full/10.1080/14787210.2017.1308823

Potential role of tyrosine kinase inhibitors during primary ...

Dasatinib could be an attractive potential adjuvant of ART to treat HIV infection, particularly during primary infection. It may decrease VR and increase the ...

6.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT05780073/safety-and-impact-of-dasatinib-on-viral-persistence-and-inflammation-in-people-with-hiv-under-antiretroviral-treatment

Safety and Impact of Dasatinib on Viral Persistence ...

Daily administration of a low dose of dasatinib (70 mg once daily) to PWH for 24 weeks will be safe and well tolerated. Dasatinib will interfere ...

7.

clinicaltrial.be

clinicaltrial.be/en/details/428177?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Safety, Tolerance and Antiretroviral Activity of Dasatinib

Study to evaluate the safety, tolerability and antiretroviral activity of a new therapeutic strategy, based on the administration of ...

8.

trialx.com

trialx.com/clinical-trials/listings/263650/safety-and-impact-of-dasatinib-on-viral-persistence-and-inflammation-in-people-with-hiv-under-antiretroviral-treatment/

Safety and Impact of Dasatinib on Viral Persistence ...

Dasatinib will interfere with HIV-1 persistence mechanisms contributing to chronic immune activation and inflammation status in both concordant and immune- ...