Safety, tolerance and antiretroviral activity of IMP: a pilot clinical trial in patients with recent HIV-1 infection

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02]

Trial duration

26 Jan 2026 → ongoing

Decision date (initial)

2024-12-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Instituto de Salud Carlos III

External identifiers

EU CT number

2024-519641-30-00

EudraCT number

2021-001288-26

ClinicalTrials.gov

NCT05527418

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Dose response

The overall objective of the project is to evaluate the safety and tolerability of a new therapeutic strategy, based on the administration of dasatinib, an ITK.
The safety and tolerability of dasatinib will be evaluated in patients with recent (more than 3 months) asymptomatic HIV-1 infection.

Secondary objectives 6

1. 1. To assess the in vivo antiretroviral capacity of dasatinib by quantification of plasma HIV-1 viral load during 4-week administration of dasatinib monotherapy.
2. 2. To assess changes in the viral reservoirs of patients with recent HIV-1 infection induced by dasatinib administration.
3. 3. To assess changes in markers of inflammation and immune activation induced by dasatinib administration.
4. 4. To assess the changes in SAMHD1 phosphorylation levels and cytotoxic activity against HIV-1 induced by dasatinib.
5. 5. To assess the tolerability and pharmacokinetic interactions of coadministration of non-boosted integrase inhibitor-based antiretroviral therapy with dasatinib.
6. 6. To assess the impact of dasatinib on markers of senescence.

Conditions and MedDRA coding

Asymptomatic patients with recent HIV-1 infection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. -Age range: 18 to 65 years.
2. -Documented asymptomatic HIV-1 infection of more than 3 months duration (all patients must have a positive Western blot, including the p31 band, indicating an infection of more than 90 days duration).
3. -Not having received ART.
4. -CD4 T lymphocyte count > 350 / μl.
5. -Patient giving written informed consent.

Exclusion criteria 8

1. -Active HBV (HBsAg+ or DNA+) and/or HCV (RNA+) infection on screening.
2. -ALT> 2 UNL, glomerular filtration rate <70 mL / 1.73 m2, leukocytes <4000 / mm3, total lymphocyte count <1000 / mm3, platelets <100,000 / mm3 or Hg <12g / dL.
3. -Pregnancy or active breastfeeding
4. -Ongoing or previous pleural effusion
5. -Chronic obstructive pulmonary disease, bronchial asthma or recent chest trauma.
6. -History of gastrointestinal or other bleeding.
7. -Any concomitant treatment with potentially dangerous drug interaction with dasatinib.
8. -Any clinical condition, at the opinion of the investigator, contraindicating participation (for example, active neoplastic disease, active concomitant infection, etc.)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint of the study is to assess the safety and tolerability of dasatinib with and without antiretroviral therapy using the incidence of AA.

Secondary endpoints 3

1. Immunological endpoints: -immune recovery (CD4 subpopulation levels). -inflammatory markers (ultra-sensitive CRP, IL6, TNF alpha) -immune activation (CD4/CD8, CD25, CD69, CD38, HLA-DR+) -bacterial translocation (rsCD163) -levels of NK-mediated cytotoxic activity (NK phenotyping and in vitro replication inhibition tests).
2. Virological endpoints: -decline in HIV viral load prior to ART initiation (4 weeks of dasatinib monotherapy) -impact on the viral reservoir (integrated DNA, genetically intact virus, residual and induced viral replication and determination of integration sites) -SAMHD1 phosphorylation levels
3. Senescence endpoints: -Expression in PBLs of beta-galactosidase, Bcl-2, Histone H2A, p16 and CD87.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Sponsor organisation

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Address

Calle Rosellon 149-153

City

Barcelona

Postcode

08036

Country

Spain

Scientific contact point

Organisation

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Contact name

Josep Maria Miró Meda

Public contact point

Organisation

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Contact name

Josep Maria Miró Meda

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications