EUCTR2012-002281-12-DE进行中（未招募）不适用
Re-boosting of Subjects Previously Included in the CT BI-Vacc-4x 2007/1 Study. An Open, Multicenter, Immunogenicity, Follow-up Reboosting Study with Vacc-4x in Subjects 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
- 40
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. Completed immunization regimen with Vacc-4x active and stopped ART (at Week 28) in the CT-BI Vacc-4x 2007/1 study. (No re-start of ART is required).
- •2. Documented pre-study CD4 cell count =400x10e6/L.
- •3. Documented pre-study viral load < 300 000 copies/mL.
- •4. 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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Reported AIDS-defining illness within the previous year.
- •2. Malignant disease.
- •3. On chronic treatment with immune-suppressive therapy.
- •4. Unacceptable values of the hematologic and clinical chemistry parameters, as judged by the Investigator, including creatinine values >1.5 x upper limit of normal (ULN), and AST, ALT and alkaline phosphatase (ALP) values >2.5 x ULN.
- •5. Concurrent chronic active infection such as viral hepatitis B or C or tuberculosis.
- •6. Pregnant or breastfeeding women.
- •7. Women of childbearing 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; sterile) during the 5 weeks re-boosting
- •period including the DTH and for 2 weeks after the DTH test, or sexually active male subjects with partners of child bearing potential unwilling to practice effective contraception during the 5 weeks re-boosting period including the DTH and for 12 weeks after the DTH-test.
- •8. Current participation in other clinical therapeutic studies.
- •9. Incapability of compliance to treatment protocol, in the opinion of the Investigator
研究者
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