EUCTR2007-006302-13-IT进行中（未招募）不适用
A Phase II, Randomized,Double-blind,Multicenter,Immunogenecity Study of Vacc-4x Versus Placebo in Patients Infected with HIV-1 Who Have Maintained an Adequate Response to ART - CT BI-Vacc-4x 2007/1
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 345
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
- •HIV positive for at least 1 year, stable on ART for the last 6 months,18-55 years old,viral load less then 50 copies/ml for the last 6 months,have a pre-study CD4 count more or equal 400x10 6 /l, a nadir CD4 count more or equal 200 x 10 6 /l,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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Reported pre-study AIDS defining clinical complications,malignant disease,on chronic treatment with immune-supressive therapy,unacceptable values of the hematologic and clinical chemistry parameters,concurrent chronic active infection,pregnant or breastfeeding woman,woman of childbearing potential not using adequate contraceptive methods.participation in other clinical therapeutic studies, incapable of compliance to the protocol.
研究者
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A Phase II, Randomized, Double-Blind, Multicenter, Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected with HIV-1 Who Have Maintained an Adequate Response to ARTHIV positive subjects who have been clinically stable on antiretroviral therapy for the last six months with a viral load less than 50 copies/mL for the last six months and a CD4 cell count => 400 x 10^6/L and who meet the other inclusion and exclusion criteria of the protocolMedDRA version: 12.0Level: LLTClassification code 10020161Term: HIV infectionEUCTR2007-006302-13-DEBionor Immuno AS120
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