EUCTR2006-006212-30-GB进行中（未招募）1 期
A Randomised, Open labelled, Phase II, Immunogenicity, and Exploratory Efficacy Evaluation of Therapeutic Immunisations +/- IL-2, GM-CSF and Growth Hormone in HIV-1 Infected Subjects Receiving Highly Active Anti-retroviral Therapy (HAART). - Novel Interventions in HIV-1 Infection.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •- Documented HIV-1 positive result.
- •-Stable on HAART.
- •-Two screening viral load of <50 cps/ml on 2 consecutive occasions at least one month apart?
- •-CD4 T cell count of >400 cells/ul.
- •- Nadir CD4 T cell count of >200 cells/ul.
- •-Over 18 years of age.
- •-Willing and able to provide informed consent.
- •-Female subjects must not be pregnant or lactating.
- •-Subjects must be using adequate double barrier method of contraception as appropriate.
- •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
- •-Prior therapeutic vaccination.
- •-Acute illness within 2 weeks of the start of the study.
- •-Prior immunomodulatory therapy (e.g. IL-2, rhGH, GCSF, GM-CSF, HU) within the 6 months preceding baseline.
- •-Receiving immunosuppressive medication (e.g. Steroids)
研究者
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