Dasatinib + Quercetin for HIV

(IPACE-HIV Trial)

Recruiting at 26 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must be taking: Antiretrovirals

Must not be taking: CYP3A4 interactors

Disqualifiers: Active cancer, Liver disease, Dialysis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combination of dasatinib (a cancer drug) and quercetin (a plant flavonoid) can improve physical function in people with HIV. Participants will receive either this treatment or a placebo for comparison. The study targets individuals who have lived with HIV for at least 10 years, are 50 or older, and experience frailty. Participants must be on stable HIV medication with controlled virus levels. The goal is to determine if the treatment can enhance daily life over 12 weeks, followed by another 12 weeks of monitoring. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you cannot take medications that affect CYP3A4 or interact with dasatinib. It's best to discuss your current medications with the study team to see if they are compatible with the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using dasatinib and quercetin (D+Q) together is generally safe. Studies have found that this combination can improve health in healthy individuals. Dasatinib may also help fight HIV by protecting the body's natural defense cells. While the safety for people with HIV and frailty is still under investigation, past research in other groups suggests that D+Q is well-tolerated. This trial is in Phase 2, indicating some early evidence of safety, but more data is needed to confirm these findings in the specific group being studied. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Dasatinib and Quercetin for HIV treatment because they bring a fresh approach to managing the condition. Unlike traditional HIV therapies that primarily focus on inhibiting viral replication, Dasatinib is a tyrosine kinase inhibitor that may also target latent HIV reservoirs, potentially reducing the virus's ability to hide and persist in the body. Quercetin, a natural flavonoid, is thought to have anti-inflammatory and antiviral properties, which might complement Dasatinib by enhancing immune function and further suppressing the virus. This combination could offer a novel strategy for tackling HIV, potentially making it a game-changer in the pursuit of a functional cure.

What evidence suggests that the D+Q treatment could be effective for improving physical function in people with HIV?

This trial will compare the combination of dasatinib and quercetin with a placebo. Research has shown that using dasatinib and quercetin together might improve physical abilities in people with HIV. Lab studies have demonstrated that this combination effectively targets cells that have stopped functioning properly, often associated with aging and frailty. Dasatinib can also hinder HIV from hiding in the body by affecting certain immune cells, while quercetin aids in eliminating these problematic cells. Although more human studies are needed, these findings suggest that this combination could help address frailty in people living with HIV. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for people aged 50 or older who have been living with HIV for at least a decade, are frail or prefrail, and on stable antiretroviral therapy with controlled virus levels. It's not suitable for those outside this age range or without a long-term diagnosis of HIV.

Inclusion Criteria

I have shown signs of frailty as per specific criteria within the last 60 days.

Must have eGFR > 30 using CKD-EPI per 2021 calculation equation

I am 50 years or older and have been diagnosed with HIV-1.

Exclusion Criteria

I have not had a heart attack, angina, stroke, or mini-stroke in the last 6 months.

I take medications that may interact with dasatinib.

I haven't been seriously ill in the last 60 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dasatinib and quercetin (D+Q) or placebo in six cycles over 12 weeks, with medication taken for two days followed by 12 days without treatment

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dasatinib
• Quercetin

Trial Overview

The study tests if dasatinib plus quercetin (D+Q) can improve physical function in older adults with HIV. Participants will be randomly assigned to receive either D+Q treatment or placebo over six cycles in 12 weeks, followed by another 12-week observation period.

How Is the Trial Designed?

Group I: Arm A: D+Q Experimental Treatment 2 Interventions

Group II: Arm B: Placebo Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7325840/

Senotherapeutics for HIV and Aging - PMC - PubMed Central

Quercetin has shown synergistic activity with dasatinib in vitro (105), and this combination represents the current intervention strategy for pilot senolytic ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0006295224004957

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

We observed that short-term treatment in vitro with dasatinib significantly reduced pSAMHD1 in monocyte-derived macrophages (MDMs) isolated from people with HIV ...

3.

mdpi.com

mdpi.com/2073-4409/11/7/1222

Senotherapeutics in Cancer and HIV

Dasatinib induced the death of senescent human preadipocytes but was much less effective on senescent human umbilical vein epithelial cells (HUVECs) [67].

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04733534

Study Details | NCT04733534 | An Open-Label Intervention ...

The primary aim of this proposal is to test the efficacy of two, short duration senolytic regimens: 1) combination of Dasatinib plus Quercetin and 2) Fisetin ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11410549/

Emerging roles of senolytics/senomorphics in HIV-related co ...

In fact, Bermejo and colleagues have observed that dasatinib treatment can limit HIV-1 replication by inhibition of CD4+T-cell proliferation and blocking the ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04946383

Safety and Effectivness of Quercetin & Dasatinib on ...

There is evidence that Dasatinib+Quercetin(Quercetin and Dasatinib) is a safe and effective treatment option to improve clinical care of healthy individual's ...

7.

clinicaltrials.ucsd.edu

clinicaltrials.ucsd.edu/hiv-aids

UCSD HIV/AIDS Clinical Trials for 2025 — San Diego

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 ...