Evaluating dasatinib for treating recent HIV-1 infection
Safety, Tolerance and Antiretroviral Activity of Dasatinib: a Pilot Clinical Trial in Patients With Recent HIV-1 Infection
This study is testing if the medication dasatinib can safely help people who have recently been diagnosed with HIV-1 feel better and manage their condition.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Institut d'Investigacions Biomèdiques August Pi i Sunyer Academic / other |
| Drugs / interventions | dasatinib |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05527418 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety, tolerability, and antiretroviral activity of dasatinib in patients who have recently been diagnosed with asymptomatic HIV-1 infection, specifically those infected for 3 to 12 months. Participants will receive either dasatinib or a placebo, and the study will monitor their health and immune response. The goal is to determine if dasatinib can effectively manage HIV-1 in its early stages without prior antiretroviral therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a documented asymptomatic HIV-1 infection lasting 3 to 12 months and a CD4 T-lymphocyte count greater than 350 cells/μl.
Not a fit: Patients with active hepatitis B or C infections, significant liver or kidney dysfunction, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for managing recent HIV-1 infections.
How similar studies have performed: While this approach is novel, similar studies exploring new treatments for HIV-1 have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 to 65 years. * Documented asymptomatic HIV-1 infection of 3-12 months duration (all patients must have a positive Western blot, including the p31 band whose appearance indicates infection of more than 90 days duration). * Not having received ART * CD4 T-lymphocyte count\> 350 / μl * Patient giving written informed consent Exclusion Criteria: * Active HBV (HBsAg+ or DNA+) and/or HCV (RNA+) infection in screening. * 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. * Pregnancy or active breastfeeding * Ongoing or previous pleural effusion * Chronic obstructive pulmonary disease, bronchial asthma or recent chest trauma. * History of gastrointestinal or other bleeding. * 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.)
Where this trial is running
Barcelona
- Eva Bonfill — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Eva Bonfill
- Email: bonfill@recerca.clinic.cat
- Phone: +34 932275400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.