EUCTR2019-004871-38-ES进行中（未招募）1 期
Phase IV, single-center, open study to assess the benefits of the start of immediate treatment without immunovirological data (Same Day Treatment”) compared to conventional treatment with BIC / FTC / TAF in naive patients with type 1 HIV infection
FUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE0 个研究点目标入组 20 人开始时间: 2020年2月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- •Men and women ? 18 years old
- •Confirmed and documented diagnosis of HIV-1 infection
- •Without prior antiretroviral treatment (excluding 28-day post-exposure prophylaxis)
- •Signed informed consent
- •Negative pregnancy test (women of childbearing age only). Women of childbearing age are considered to be those women who have not undergone permanent infertility procedures or who have been amenorrheic for less than 12 months
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Inability to obtain written informed consent to participate in the study
- •Pregnant or breastfeeding women or those who intend to become pregnant during the study period and do not undertake to use proven contraceptive methods
- •Any suspicion or confirmation of resistance to TAF, FTC or BIC
- •Estimated glomerular filtration rate (TFGe) <30 mg / ml / m2 measured by any of the available formulas. The determination of the TFGe of a routine prior analysis of = 12 weeks prior to the signing of the consent is allowed
- •Contraindications to the use of TAF
- •Clinical condition of the patient in rapid deterioration or the investigator considers that there is no reasonable hope that the patient will end the study
- •Simultaneous participation in another clinical trial or research study that requires the need for treatment with other drugs outside the study or interferes with visits to it.
- •Any situation that, in the opinion of the investigator, may interfere with the patient's ability to comply with the treatment schedule and protocol evaluations
研究者
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