NCT02370979Unknown4 期
Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients
University Hospital, Strasbourg, France8 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2015年2月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 202
- 试验地点
- 8
- 主要终点
- Change from baseline in Proviral HIV-1 DNA at Week 48
研究概览
简要总结
This is a multi-center prospective study. The primary objective of DRONE study is to investigate the change of the size of HIV-1 DNA reservoir in blood from baseline to week 48 (W48) in participants treated by DTG-based regimen. Secondary objectives include: DTG pharmacokinetic and analysis of biomarkers of immune activation from baseline to W48.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged from de 18 to 80 years
- •Patient starting a DTG-regimen
- •Patients agreeing to use methods of birthcontrol while on the study and during the 6 weeks after stopping DTG treatment
- •Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening
排除标准
- •Women who are pregnant or breastfeeding
- •HBV or HCV coinfection
- •Participation in another clinical drug or device trial where the last dose of drug was within the past 30 days or an investigational medical device is currently implanted
- •An active AIDS-defining condition at Screening
- •Documented resistance to DTG
- •Allergy or intolerance to the study drugs or their components or drugs of their class
- •Any acute or verified Grade 4 laboratory abnormality (with the exception of Grade 4 lipids) at Screening.
- •Coadministration with Dofelitide
结局指标
主要结局
Change from baseline in Proviral HIV-1 DNA at Week 48
时间窗: baseline (Day 0) and Week 48
次要结局
- Dolutegravir pharmacokinetic (dolutegravir pharmacological blood levels)(Week 4, Week 24 and Week 48)
- Quantification of biomarkers of immune activation(baseline (Day 0), Week 24 and Week 48)
研究者
研究点 (8)
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