EUCTR2018-000497-30-ES进行中（未招募）1 期
Phase II clinical trial to evaluate the safety and efficacy of Vedolizumab combined with antiretroviral treatment to achieve functional healing in people infected with HIV-1 without previous antiretroviral treatment.
Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)0 个研究点目标入组 12 人开始时间: 2018年3月14日最近更新:
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
- 12
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
- •- Patients with HIV infection and age = 18 years and <65 years.
- •- Detectable viremia (>1x104 copies RNA/ ml )
- •- Levels of CD4 + > 350 cells / µL.
- •- Accept analytical interruption of the treatment.
- •- Written informed consent.
- •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 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Presence of major resistance mutations to any of the study drugs.
- •- Active opportunistic infections.
- •- Pregnancy.
- •- Active co-infection with hepatitis B or C virus or latent infection with untreated TB.
- •- Cirrhosis, portal hypertension and / or hypersplenism of any etiology.
- •- Past or current neoplasms subsidiary to treatment with steroids, immunomodulators or chemotherapy
- •- Laboratory abnormalities grade 3 or 4.
- •- Concomitant use of drugs with greater pharmacological interactions with the study drugs, according to the respective technical specifications of the products.
- •- Estimated creatinine clearance < 50ml / min.
- •- Have received any type of vaccination (eg, hepatitis B virus, influenza ...) two weeks before the start of the study.
- •- Cardiovascular disease (eg, angina, heart failure, recent acute coronary syndrome)
- •- Neurological or neuropsychiatric disease whose symptoms may interfere with the assessment of safety and tolerability.
- •- Active abuse of alcohol and / or drugs or any pattern of behavior that, in the opinion of the researcher, could interfere with adherence to study drugs
研究者
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