EUCTR2017-004137-91-ES进行中（未招募）1 期
A single-arm, open-label, multicenter phase IV trial to evaluate the efficacy and safety of elvitegravir / cobicistat / emtricitabine / tenofovir alfa-namide as first-line treatment in naïve patients with HIV-1 infection with severe immunosuppression - GENIS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Have voluntarily granted informed consent before carrying out the specific procedures of the trial.
- •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 going to be tested for genotypic resistance to inhibitors of intregrasa, emtricitabine or tenofovir (will be scheduled at the screening visit or selection / baseline visit in the event that both visits coincide).
- •Creatinine clearance = 30 mL / min before the start of treatment.
- •ALT / AST levels not higher than five times normal levels, total bilirubin with normal values, neutrophils> 1000 cells / µL,> 50000 platelets / µL,> 85 g / L Hb, and serum amylase levels <1.5 times the upper normal limit before the start of treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient receiving any concomitant treatment described as not allowed. Patient with documented intolerance or hypersensitivity to the study medication, or who has a contraindication to use it, according to the technical file.
- •Patient receiving therapies with interferon, interleukin 2, cytotoxic chemotherapy or immunosuppressants at the baseline visit.
- •Patients with neoplasms, with the exception of skin carcinoma (excluding melanoma and hawthorn) and anal cancer in situ (stage 0).
- •Patient with any medical or psychological, sociological or geographical alteration, toxic habit (drugs, alcohol) that, in the opinion of the investigator, could interfere in the compliance 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, in the opinion of the researcher, could compromise the patient's ability to understand and complement the questionnaires and scales used in the study.
- •Patient in treatment with any investigational drug / product or who is participating in a clinical trial using an investigational product, 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 (such as oral contraceptives, intrauterine device or contraceptive barrier method together with spermicide or surgical sterilization) during the study and up to 3 months after the administration of the last dose of the study treatment. Women of childbearing age are defined as those women who have not undergone permanent infertility procedures or who have been amenorrheic for less than 12 months.
- •Patients with severe hepatic impairment (Child-Pugh Class C).
研究者
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