Phase IV, Single-center, Open Study to Evaluate the Benefits of the Start of Immediate Treatment Without Immunovirological Data ("Same Day Treatment") Compared to Conventional Treatment With BIC / FTC / TAF (Bictegravir/Emtricitabina/Tenofovir) in Naive Patients With Type 1 HIV (Human Immunodeficiency Virus) Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Efficacy of immediate treatment.
研究概览
简要总结
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 (human immunodeficiency virus) infection
详细描述
150 patients (75 in each treatment arm) with a confirmed diagnosis of HIV-1 infection and without prior antiretroviral treatment will be included.
Expected study period 48 weeks of treatment Main objective of effectiveness Determine the time from the first determination of CD4 and HIV-1 viral load to achieve HIV viral load <50 cop / ml.
Secondary objectives of efficacy
- Evaluate changes in CD4 T cell count.
- Determine the time from HIV diagnosis to achieve undetectable HIV viral load.
- Determine the degree of anxiety of patients.
- Determine the number of sexual contacts with potential for transmission of HIV infection.
- Determine the quality of patients before and after SDT. Both arms of the study have the same treatment with triple therapy (BIC / FTC / TAF).
The treatment guidelines will be as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
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
结局指标
主要结局
Efficacy of immediate treatment.
时间窗: 48 weeks
The time in weeks from the first determination of CD4 and HIV-1 viral load until achieving HIV viral load \<50 cop/ml, in number.
次要结局
- Secondary Efficacy Endpoints(48 weeks)
研究者
Irene Carrillo
Subinvestigator Infectious disease. Irene Carrillo
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz