EUCTR2005-001490-95-IT进行中（未招募）不适用
A Randomized, open label, international study of subcutaneous recombinant interleukin-2 with and without concomitant antiretroviral therapy in patient with HIV-1 infectious and CD4+ cell count >300/mm3 - STALWART
ational Institute of Allergy and Infectious Diseases0 个研究点目标入组 300 人开始时间: 2007年6月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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 - > age 18 - CD4 > 300/mmc - AST e ALT < 5X the upper limit of normal - bilirubinemia < 2x the normal ranges - Creatininemia<2 mg/dl - Granulocyte count >1000/mmc - Hemoglobin>10 g/dl. - No use ofvany ART since 1 year - Absence of autoimmune, cardiovascolar and neurologic diseases that can limited the use of IL-2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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
- •-use of any immunomodulants - age< 18 -Any prior use of IL-2- presence of neoplasies except sarcoma Kaposi mucocutaneous - History of any AIDS-defining events- use of corticosteroids, chemotherapy or experimental cytotoxic drug within 45 days prior to randomization -Any CNS abnormality that requires ongoing treatment with antiseizure medication -Pregnancy or breastfeeding -Psichiatric diseases or illicit substance use/abuse that would make the partecipant not candidate for the study
研究者
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