EUCTR2013-004747-23-DK进行中（未招募）不适用
An Open Phase I/IIa Study to Evaluate the Safety and Effect of Therapeutic HIV-1 Immunization using Vacc-4x + rhuGM-CSF, and HIV-1 Reactivation using Romidepsin, on the Viral Reservoir in Virologically Suppressed HIV-1 Infected Adults on cART - REDUC
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •1) Age >18 years
- •2) Currently receiving cART and having received cART for a minimum of 1 year
- •3) HIV-1 plasma RNA <50 copies/mL for at least 1 year (excluding viral load blips)
- •4) CD4 T-cell count =500 cells/mm3 at screening
- •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 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1) CD4 T cell count nadir <200 cells/mm3
- •2) Previous treatment with an HDACi (Histone deacetylase inhibitor) within the previous 6 months
- •3) Any evidence of an active AIDS-defining opportunistic infection, active HBV or HCV co-infection, significant cardiac disease, malignancy, transplantation, insulin dependent diabetes mellitus or other protocol defined excluded medical condition
- •4) Use of any protocol defined contraindicated medication or vaccination
- •5) Unacceptable values of the hematologic and clinical chemistry parameters as defined in the protocol.
- •6) Males or females who are unwilling or unable to use protocol defined methods of contraception
研究者
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