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

Phase 1

• Conditions: Human immunodeficiency virus; MedDRA version: 20.1Level: PTClassification code: 10020161Term: HIV infection Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: CTIS2024-513714-36-01
• Lead Sponsor: Instituto De Investigacion En Ciencias De La Salud Germans Trias I Pujol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified