A Clinical Trial to Evaluate the Efficacy and Safety of Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Alafenamide as a First-line Treatment in Naïve Patients With HIV-1 Infection With Severe Immunosuppression

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追踪信息

首次提交日期 ^ICMJE

October 1, 2018

首次发布日期e ^ICMJE

October 3, 2018

最后更新发布日期

October 4, 2018

预计研究开始日期 ^ICMJE

April 13, 2018

预计主要完成日期

May 31, 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Percentage of patients with undetectable plasma viral load[ Time Frame: Week 48 ]

study the effectiveness of the combination of TAF/FTC/EVG-cb

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Proportion of patients with virological failure[ Time Frame: From basal until week 48 ]
Proportion of patients with Plasma viral load of HIV-1 RNA ≥50 copies / mL in the last measurement while the patient receives the treatment in the window period, patients who interrupt the treatment prematurely due to lack / loss of efficacy in which the last viral load was ≥50 copies / mL or in which the antiretroviral treatment was modified before 48 weeks.
Proportion of patients with virological failure[ Time Frame: From basal visit until week 48 ]
Proportion of patients who interrupt the treatment prematurely due to absence or loss of efficacy
Proportion of patients with virological failure[ Time Frame: From basal visit until week 48 ]
Proportion of patients who interrupt the treatment prematurely by others reasons (other than an adverse event, death or loss of effectiveness) and whose last viral load at the time of abandonment was ≥50 copies / mL.
Time to virological suppression[ Time Frame: From basal until week 48 ]
viral load <50 copies / mL
Proportion of patients with virological failure while receiving antiretroviral treatment (ART), having previously been suppressed .[ Time Frame: From basal until week 48 ]
virological failure defined by protocol as viral load> 1000 copies / mL at week 24 or 2 consecutive viral loads> 50 copies / mL (at least 2 weeks apart)
Time to virological failure[ Time Frame: From basal until week 48 ]
Viral load ≥50 copias/mL
Incidence of genotypic resistance in patients with virological failure[ Time Frame: From basal until week 48 ]
Changes in viral load[ Time Frame: Weeks 4, 8, 12, 24, 36 and 48 ]
plasma concentration of HIV RNA
Change in the CD4+ lymphocyte count[ Time Frame: Week 48 ]
Proportion of patients who have a CD4+ lymphocyte count > 200 cells / μL[ Time Frame: Week 48 ]
Mean time to reach a CD4 + lymphocyte count> 200 cells / μL[ Time Frame: From basal until week 48 ]

描述性信息

简略标题 ^ICMJE

A Clinical Trial to Evaluate the Efficacy and Safety of Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Alafenamide as a First-line Treatment in Naïve Patients With HIV-1 Infection With Severe Immunosuppression

正式标题 ^ICMJE

Phase IV, Open, Multicentre, Single-arm Study to Evaluate the Efficacy and Safety of Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Alafenamide as a First-line Treatment in Naïve Patients With HIV-1 Infection With Severe Immunosuppression.

简要概况

Phase IV, open, multicentre and single-arm study. 50 HIV infection naive patients with severe immunosuppression will be recruited to evaluate the efficacy and safety of elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide as a first-line treatment.

详细说明

The patients included in the study will be treated during 48 weeks and will have to perform the selection/basal visit, week 4 visit, week 8 visit, week 12 visit, week 24 visit, week 48 visit and follow up visit.

研究类型 ^ICMJE

Interventional

研究阶段

Phase 4

研究设计 ^ICMJE

分配:
干预模型: Single Group Assignment
干预模型描述: Single arm, phase 4 study. The naive patients will be treated with elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide as a first-line treatment
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Genvoya®
Patents treated with elvitegravir (EVG) 150mg / cobicistat (COBI) 150mg / emtricitabine (FTC) 200mg / tenofovir (TAF) 10mg once a day as the first line treatment.

研究工具

Experimental: Arm 1
Naive HIV patients with severe immunosuppression.

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

May 31, 2020

预计主要完成日期

May 31, 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Patients able to give their written consent to participate in the study after having received information about the design, the purposes of the study, the possible risks that may arise from it and the possibility of withdrawing from it at any time. moment - Adult patients (age ≥18 years) of both sexes - Patients with HIV-1 infection with severe immunosuppression, defined by a concentration of CD4 + lymphocytes <200 cells / μL - Patients who are allowed to perform a genotypic resistance test to inhibitors of intregrase, emtricitabine or tenofovir - Creatinine clearance ≥ 30 ml / min before the start of treatment - Alanine transaminase (ALT) / Aspartate transaminase (AST) levels not higher than five times normal levels, total bilirubin with normal values, neutrophils> 1000 cells / μL,> 50000 platelets / μL,> Hb level of 85 g / L and serum amylase levels <1 , 5 times higher normal limit before the start of treatment Exclusion Criteria: - Patient who undergoes a concomitant treatment not allowed. Patient with documented intolerance or hypersensitivity to the study medication, or who is contraindicated to use it, attending a technical file - Patient receiving therapies with interferon, interleukin 2, cytotoxic chemotherapy or immunosuppressants at the baseline visit. - Patients with neoplasms, an exception of skin cancer and anus cancer in situ (stage 0) - Patient with any medical or psychological, sociological or geographical alteration, toxic habit (drugs, alcohol) that, a criterion of the researcher, may interfere in the fulfillment of the study by the patient. These conditions will be discussed with the patient before their inclusion in the trial - Patients with any medical or psychological alteration that, a criterion of the investigator, an involuntary factor of the patient's ability to understand and complement the questionnaires and scales used in the study - Patient in a treatment with any type of drug / product under investigation or who is participating in a clinical trial that uses a product under investigation, with the exception of studies in which the study treatment was completed more than 12 weeks ago - Pregnant women, in breastfeeding period or with a positive pregnancy test in the selection period; women of childbearing age and sexually active who are not willing to use an adequate contraceptive method during the study and up to 3 months after the administration of the last dose of study treatment. Some women in adulthood have undergone permanent infertility procedures or amenorrheic procedures for less than 12 months - Patients with severe hepatic impairment (Child-Pugh Class C).

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：100 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

Spain

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Fundacion SEIMC-GESIDA

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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