NCT02766049已完成1 期
Phase I/II Study of Anti-HIV Cellular Therapy Based on Dendritic Cells Pulsed With Chemically Inactivated Virus
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Number of participants with ≥ grade 3 adverse events related to product
研究概览
简要总结
The aim of this study was to assess tolerability and safety of three different formulations of an anti-HIV immunotherapy based on autologous dendritic cells (DCs) pulsed with HIV chemically inactivated with Aldrithiol™-2 (AT-2). Patients were chronically infected with HIV, naïve for antiretroviral drugs. A possible immunological and virological favorable impact was also assessed.
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
- •patients with HIV infection;
- •absence of antiretroviral therapy, antineoplastic therapy or the use of corticosteroids for at least six months prior to study entry;
- •plasma viral load ≥ 1,000 copies / mL, stable (ie no variation > 0.5 log) in the six months before the start of the study;
- •blood CD4+ T cells ≥ 350 /mL, stable (ie no variation > 25%) in the six months before the start of the study.
排除标准
- •individuals without proper venous access for blood and apheresis collection procedure.
- •use of drugs, alcohol, psychiatric disorder or any condition that interferes with the ability of patients to follow the requirements of the study;
- •history of diagnosis of HIV infection <01 years;
- •pregnancy or breast-feeding;
- •use of antiviral therapy, in anticancer therapies or corticosteroids six months prior to study start;
- •presence of chronic diseases, such as infection with hepatitis B (HBV) and C (HCV), human T-lymphotropic virus (HTLV) I / II or any condition that promotes immune system dysfunction, with the exception of HIV infection.
结局指标
主要结局
Number of participants with ≥ grade 3 adverse events related to product
时间窗: 51 weeks
AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004
次要结局
- Number of participants with change in plasma viral load from baseline, over the observation period(Baseline to 51 weeks)
- Number of participants with change in CD4+T cells from baseline, over the observation period(Baseline to 51 weeks)
研究者
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