临床试验/NCT02557997

NCT02557997Unknown不适用

Effects of Dolutegravir Based Regimen on HIV-1 Reservoir and Immune Activation

University Hospital, Strasbourg, France1 个研究点分布在 1 个国家目标入组 202 人开始时间: 2014年4月最近更新: 2015年9月23日

适应症

试验速览

阶段: 不适用
发起方
入组人数: 202
试验地点: 1
主要终点: Change from baseline in Proviral HIV-1 DNA at Week 48

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

We aim at comparing markers of HIV reservoir, monocyte function and immune activation between antiretroviral therapy (ART)-naïve (chronic infection or primary infection), ART-controlled or ART-failing HIV infected adults initiating a dolutegravir (DTG)-based regimen. The investigators' purpose is to measure cell associated HIV-1 DNA, monocyte function [soluble CD14 (sCD14), soluble CD163 (sCD163)], and immune activation [neopterine, interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hsCRP)] biomarkers at different time points between baseline and week 48 post DTG-based regimen initiation in each group.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

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
•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 and 48 weeks post DTG-based regimen initiation

次要结局

Quantification of biomarkers of immune activation(Baseline, 24 and 48 weeks post DTG-based regimen initiation)

研究者

发起方

University Hospital, Strasbourg, France

申办方类型

Other

责任方

Sponsor

研究点 (1)

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