Safety, Tolerance and Antiretroviral Activity of Dasatinib: a Pilot Clinical Trial in Patients With Recent HIV-1 Infection
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Safety and tolerance of dasatinib with and without antiretroviral therapy, measured by number of AEs and SAEs
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 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
排除标准
- •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.)
研究组 & 干预措施
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.
干预措施: Dasatinib (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerance of dasatinib with and without antiretroviral therapy, measured by number of AEs and SAEs
时间窗: 52 weeks
Measured by number of AEs and SAEs
次要结局
- Pharmacokinetic interactions of coadministration non-boosted integrase inhibitor-based antiretroviral therapy with dasatinib.(at week 1, 2, 3, 4, 8, 12, 16)
- Antiretroviral capacity of dasatinib(at week 0 and 4)
- Changes in the viral reservoirs of patients with recent HIV-1 infection induced by dasatinib administration.(at week 0, 4, 16 and 52)
- Changes in markers of inflammation and immune activation induced by dasatinib administration.(at week 0, 4, 16 and 52)
- Changes in SAMHD1 phosphorylation levels and cytotoxic activity against HIV-1 induced by dasatinib.(at week 0, 4, 16 and 52)
- Impact of dasatinib on markers of senescence(at week 0, 4, 16 and 52)
研究者
Eva Bonfill
Clinical Research Manager
Institut d'Investigacions Biomèdiques August Pi i Sunyer