Clinical trial NCT05527418: Safety, Tolerance and Antiretroviral Activity of Dasatinib: a Pilot Clinical Trial in Patients With Recent HIV-1 Infection
Official title: Safety, Tolerance and Antiretroviral Activity of Dasatinib: a Pilot Clinical Trial in Patients With Recent HIV-1 Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Recent HIV-1 Infection
Lead sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to evaluate the safety, tolerability and antiretroviral activity of a new therapeutic strategy, based on the administration of dasatinib, an ITK, in patients with recent (3-12 months) asymptomatic HIV-1 infection.


Eligibility 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.)

Primary outcomes:
measure: Safety and tolerance of dasatinib with and without antiretroviral therapy, measured by number of AEs and SAEs
timeFrame: 52 weeks
Secondary outcomes:
measure: Antiretroviral capacity of dasatinib
timeFrame: at week 0 and 4
measure: Changes in the viral reservoirs of patients with recent HIV-1 infection induced by dasatinib administration.
timeFrame: at week 0, 4, 16 and 52
measure: Changes in markers of inflammation and immune activation induced by dasatinib administration.
timeFrame: at week 0, 4, 16 and 52
measure: Changes in SAMHD1 phosphorylation levels and cytotoxic activity against HIV-1 induced by dasatinib.
timeFrame: at week 0, 4, 16 and 52
measure: Pharmacokinetic interactions of coadministration non-boosted integrase inhibitor-based antiretroviral therapy with dasatinib.
timeFrame: at week 1, 2, 3, 4, 8, 12, 16
measure: Pharmacokinetic interactions of coadministration non-boosted integrase inhibitor-based antiretroviral therapy with dasatinib.
timeFrame: at week 1, 2, 3, 4, 8, 12, 16
measure: Impact of dasatinib on markers of senescence
timeFrame: at week 0, 4, 16 and 52
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Eva Bonfill
Study officials:
References: