EUCTR2007-006302-13-GB进行中（未招募）不适用
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 ART
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
- 120
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 between 18 and 55 years
- •2. HIV positive at least one year
- •3. Clinical stable on antiretroviral therapy for the last six months
- •4. Documented viral load less than 50 copies/mL for the last six months
- •5. Documented prestudy CD4 cell count => 400 x 10^6/L
- •6. Nadir (lowest ever) CD4 cell count => 200 x 10^6/L
- •7. Signed 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
- •1. Reported pre-study AIDS defining illness within the previous year (see Appendix 15.3 of protocol)
- •2. Malignant disease
- •3. On chronic treatment with immune suppressive therapy
- •4. Unacceptable values of the haematologic and clinical chemistry parameters, as judged by the Investigator or the Sponsor (or designee) including creatinine values > 1.5 x upper limit of norma and asparatate aminotransferase (SGOT), alanine aminotransferase (SGOT) and alkaline phosphatase values greater than 2.5 x upper limit of normal
- •5. Concurrent chronic active infection such as chronic viral hepatitis B or C or active tuberculosis
- •6. Pregnant or breast feeding women
- •7. Women of childbearning potential not using reliable and adequate contraceptive methods (defined as: use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; practicing abstinence or sterile) during the 18 week treatment period and for 2 weeks after the last immunization, or sexually active male patients with partners of child bearing potential unwilling to practice effective contraception during the 18 week treatment period and for 12 weeks after the last immunization.
- •8. Concurrent participation in other clinical therapeutic studies
- •9. Incapability of compliance to the treatment protocol, in the opinion of the Investigator
研究者
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