Safety, Tolerance and Antiretroviral Activity of Dasatinib: a Pilot Clinical Trial in Patients With Recent HIV-1 Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-26

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Recent HIV-1 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dasatinib

Dasatinib monotherapy (70 mg/day) will be given for 4 weeks. Antiretroviral therapy (ART) based on unboosted integrase inhibitors will be initiated at week 4 (S4) and dasatinib will be continued with ART until week 12.

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

Dasatinib monotherapy 70 mg/day, during 16 weeks.

Placebo

Placebo monotherapy will be given for 4 weeks. Antiretroviral therapy (ART) based on unboosted integrase inhibitors will be initiated at week 4 (S4) and placebo will be continued with ART until week 12.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo during 16 weeks.

Interventions

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Dasatinib

Dasatinib monotherapy 70 mg/day, during 16 weeks.

Intervention Type DRUG

Placebo

Placebo during 16 weeks.

Intervention Type DRUG

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No