Authorised Therapeutic exploratory (Phase II) Human immunodeficiency virus

Safety and Impact of Dasatinib on Inflammation and AIDS virus in People under treatment

EU CTIS ID: 2024-513714-36-01

What this study is testing

To evaluate the safety and tolerability of dasatinib administered at 70 mg once daily during 24 weeks in PWH on suppressive ART. To evaluate the on-target/biological effect of dasatinib administered at 70 mg once daily during 24 weeks in PWH on suppressive ART on the reduction of SAMHD1 phosphorylation upon in-vitro T-cell activation, and its durability after completion of dasatinib treatment.

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Males and females aged at least 18 years on the day of screening.
10. If female, willing to undergo urine pregnancy tests at the designated time points.
11. Willing to accept blood draws at time points specified in the Schedule of Events.
2. Confirmed HIV-1 infection.
3. Receiving suppressive cART for at least 3 years (defined as maintained plasma viral load <50 copies/mL, allowing for isolated blips [<200 cop/ml, non-consecutive, representing <20% total determinations]).
4. Being on the same ART regimen within at least 4 weeks prior to baseline visit.

You likely can't join if

1. If female, pregnant or planning a pregnancy during the entire study or lactating.
10. Systemic treatment for cancer within 1 year of study entry.
11. Known hypersensitivity to any component of the IMP formulation, or severe or multiple allergies to drugs or pharmaceutical agents.
12. Potential participant received or plans to receive: a. Licensed live attenuated vaccines within 28 days before or after inflammation and immune biomarkers visit (weeks 0, 2, 24 and 48). b. other vaccines (eg, tetanus, hepatitis A, hepatitis B, rabies, pneumococcal, recombinant Herpes Zoster, Influenza, COVID-19 vaccines) within 14 days before or after inflammation and immune biomarkers visits (weeks 0, 2, 24 and 48)1.
13. Receipt of blood products within 3 months of study entry.
14. Current or recent use (within last 3 months) of interferon or systemic corticosteroids or other immunosuppressive agents (use on inhaled steroids for asthma or topic steroids for localized skin conditions are permitted).

See the full eligibility criteria

Who can join

1. Males and females aged at least 18 years on the day of screening.
10. If female, willing to undergo urine pregnancy tests at the designated time points.
11. Willing to accept blood draws at time points specified in the Schedule of Events.
2. Confirmed HIV-1 infection.
3. Receiving suppressive cART for at least 3 years (defined as maintained plasma viral load <50 copies/mL, allowing for isolated blips [<200 cop/ml, non-consecutive, representing <20% total determinations]).
4. Being on the same ART regimen within at least 4 weeks prior to baseline visit.
5. Willing and able to be adherent to their ART regimen for the duration of the study.
6. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
7. In the opinion of the Principal Investigator, the candidate has understood the information provided and can give written Informed Consent.
8. If heterosexually active female of childbearing potential1, using an effective method of contraception (hormonal contraception, intra-uterine device (IUD), or anatomical sterility in self or partner) from 14 days prior to the first IMP administration and commit to use it until 3 months after the last IMP administration. All female candidates of childbearing potential who are not heterosexually active at screening, must agree to utilize an effective method of contraception if they become heterosexually active during the study.
9. If heterosexually active male, regardless of reproductive potential, sterilized or agree on the use of an effective method of contraception by his female partner (hormonal contraception, intra-uterine device (IUD), or anatomical sterility2) from the day of the first IMP administration until 3 months after the last IMP administration. All male candidates who are not heterosexually active at screening, must agree to utilize an effective method of contraception if they become heterosexually active during the study.

What rules you out

1. If female, pregnant or planning a pregnancy during the entire study or lactating.
10. Systemic treatment for cancer within 1 year of study entry.
11. Known hypersensitivity to any component of the IMP formulation, or severe or multiple allergies to drugs or pharmaceutical agents.
12. Potential participant received or plans to receive: a. Licensed live attenuated vaccines within 28 days before or after inflammation and immune biomarkers visit (weeks 0, 2, 24 and 48). b. other vaccines (eg, tetanus, hepatitis A, hepatitis B, rabies, pneumococcal, recombinant Herpes Zoster, Influenza, COVID-19 vaccines) within 14 days before or after inflammation and immune biomarkers visits (weeks 0, 2, 24 and 48)1.
13. Receipt of blood products within 3 months of study entry.
14. Current or recent use (within last 3 months) of interferon or systemic corticosteroids or other immunosuppressive agents (use on inhaled steroids for asthma or topic steroids for localized skin conditions are permitted).
15. Any other current or prior therapy which, in the opinion of the investigator, would make the individual unsuitable for the study or influence the results of the study.
16. Any laboratory abnormalities including: Hematology · Hemoglobin <10.0 g/dl, · absolute neutrophil count ≤3,000 /mm3, · Platelets ≤100,000/mm3, Biochemistry · eGFR <60 ml/min, · AST > 2.5 x ULN, · ALT > 2.5 x ULN, Microbiology · Positive for hepatitis B surface antigen, · Positive for hepatitis C antibody, unless confirmed clearance of HCV infection (spontaneous or following treatment) · Positive serology indicating active syphilis requiring treatment2
17. Has a QTc interval ≥470 msec (males) or ≥480 msec (females) upon confirmation on recheck at screening, has a history of risk factors for Torsades de Pointes (eg, heart failure/cardiomyopathy or family history of long QT syndrome), or is taking concomitant medications that prolong the QT/QTc interval.
2. Current treatment with ART regimen that includes ritonavir, cobicistat or with any other drug with known relevant drug-drug interactions with dasatinib.
3. Has received any immunotherapy with intent to cure or prevent HIV, including monoclonal antibodies, therapeutic or preventive vaccines within 6 months prior to baseline visit.
4. Prior history of exposure to dasatinib or any other TKI.
5. Prior history of pleural effusion.
6. Prior history or clinical manifestations of any physical or psychiatric disorder that could impair the subject’s ability to complete the study.
7. Any active AIDS-defining disease or progression of HIV-related disease, except cutaneous Kaposi’s sarcoma not requiring systemic therapy.
8. Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal, or penile intraepitelial neoplasia.
9. Ongoing diabetes mellitus with poor metabolic control (requiring insulin therapy initiation, hospitalization or documented HbA1c >8% within the last 3 months).

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.