NCT05527418Active, not recruitingPhase 2
Safety, tolerance and antiretroviral activity of IMP: a pilot clinical trial in patients with recent HIV-1 infection
Safety, tolerance and antiretroviral activity of dasatinib: a pilot clinical trial in patients with recent HIV-1 infection
Source: EU CTIS (euclinicaltrials.eu) · Last updated 11 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 5 Dec 2024
- Start date
- 26 Jan 2026
- Lead sponsor
- Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
- Diseases
- HIV
- NCT number
- NCT05527418
- EU CT number
- 2024-519641-30-00
- EudraCT number
- 2021-001288-26
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 24
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- -Ongoing or previous pleural effusion
- -Any concomitant treatment with potentially dangerous drug interaction with dasatinib.
- -Any clinical condition, at the opinion of the investigator, contraindicating participation (for example, active neoplastic disease, active concomitant infection, etc.)
Other illness
- -Active HBV (HBsAg+ or DNA+) and/or HCV (RNA+) infection on screening.
- -Chronic obstructive pulmonary disease, bronchial asthma or recent chest trauma.
- -History of gastrointestinal or other bleeding.
Lab values
- -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.
Other
- -Pregnancy or active breastfeeding
Who the study is looking for
- -Age range: 18 to 65 years.
- -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).
- -Not having received ART.
- -CD4 T lymphocyte count > 350 / μl.
- -Patient giving written informed consent.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| CAP Drassanes Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| BCN Checkpoint Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.