EUCTR2017-003470-14-ES进行中（未招募）1 期
Pilot clinical trial, multicenter, to compare the efficacy of RTG 1200 QD vs DRV-cb (800-150) QD both in combination with TAF/FTC in patients with HIV and CD4 infection <200 cells/microL. - ROTDIP Study
FIMABIS Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud0 个研究点目标入组 75 人开始时间: 2018年9月17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
- 75
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
入选标准
- •- Subject = 18 years of age.
- •- HIV-1 infection.
- •- Naive to antiretroviral treatment.
- •- CD4 count at the beginning of the study <200 cells/µl.
- •- Estimated glomerular filtration = 50 mL/min, according to the formula CKD-EPI.
- •- Grant Informed Consent in writing to participate in the study.
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •- Lactating, pregnant or fertile women who do not commit to maintain contraceptive measures during the trial.
- •- Concomitant use of any drug with possible pharmacological interaction with the study drugs that it is advisable to avoid through the database for interactions at the University of Liverpool (www.hiv-druginteractions.org).
- •- Previous use of any antiretroviral for HIV infection.
- •- Resistance to the study drugs, or presence of any contraindication to use it. The inclusion in the study can be carried out before receiving the result of the resistance test. Once it is received, in case of presenting any mutation of resistance to drugs of the indicated regimen, the responsible clinical investigator will decide whether to withdraw or maintain the original treatment and, therefore, whether to withdraw or keep the patient in the study, also being able to decide whether to censure said patient in the efficacy analysis. In any case, if the patient is not removed from the trial, he will remain in the safety analysis.
- •- Therapies that include interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressants at the entrance to the study.
- •- Current consumption of alcohol or other substances that at the discretion of the investigator may interfere with the compliance of the subject study.
- •- Subjects who currently participate in any other clinical trial using a research product, with the exception of studies in which the treatment studied has been stopped for more than 12 weeks.
- •- AIDS event in diagnosis of HIV infection or in the 3 months prior to the inclusion of the study.
- •- Suspected severe hepatopathy (grades B or C of the Child-Pough classification), of any origin, according to the clinician.
- •- Any other clinical condition or previous treatment that, in the investigator's judgment, makes the subject unsuitable for the study or unable to comply with the dosage requirements.
研究者
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