EUCTR2006-001681-16-IT进行中（未招募）不适用
A pilot, open label, randomised clinical trial assessing the 12 week immunological response in HIV-1 failing subjects receiving monotherapy with emtricitabine 200 mg once a day or emtricitabine 200 mg once a week or lamivudine 300 mg once a day - The Break Study
FONDAZIONE NADIR ONLUS0 个研究点目标入组 60 人开始时间: 2006年5月25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
- 60
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
- •Subject is 18 years old Subject has given written informed consent Subject is in virological failure Subject has a screening CD4 count 8805; 500 cell/mm3 Subject is on a HAART regimen including lamivudine unchanged from at least 12 weeks Screening genotype evidencing Met 184V mutation genotype performed within 90 days before screening
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject has positive Hepatitis B surface antigen. Subject has an active opportunistic infection. Subject has been treated with interleukin 2, other immunomodulants or chemotherapeutics in the previous six months Subject is pregnant or wishes to become so.
研究者
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