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临床试验/NCT02411071
NCT02411071Unknown不适用

Clinical Implications of HIV Low-level Viremia at Times of Highly Active Antiretroviral Treatment Regimens

University Hospital, Essen1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
1
主要终点
Frequencies of low-level viremia (LLV) during ART

研究概览

简要总结

Retrospective analysis of HIV-1 positive patients treated with antiretroviral therapy in Essen (Germany) from 2004 on. Stored samples from selected patients (n=50) obtained for routine diagnostics will be used to analyze the gag gene, the V3-region of the env gene and immune cells.

详细描述

The underlying study is a retrospective analysis of HIV-1 positive patients treated with antiretroviral therapy from Essen since 2004. Stored samples obtained for routine diagnostics will be used to analyze the gag gene, the V3-region and immune cells from selected patients. By comparing different groups of patients this study aims to identify clinical implications of low-level viremia (LLV) and persistent viremia (PV) at times of highly active antiretroviral treatment regimens (cART). The objectives of this study is to (1) determine how often LLV and PV occured during cART in Essen in the last 10 years and whether specific patterns can be correlated, (2) whether the evolution of PI drug resistance can be detected earlier in the gag than in the protease gene, (3) what kind of cellular tropism do HIV-1 isolates (RNA and proviral DNA) have at times of LLV, and (4) what kind of immune cells circulate in the blood during LLV and PV and what kind of functional properties do they have. The groups include patients starting cART as well as patients with cART. Furthermore, clinical data of patients are routinely documented and will be combined with results specifically obtained in this study in an anonymized data set. Since this is a retrospective study, there are no specific endpoints.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic HIV-1 infection
  • Age > 18 years
  • Patients treated in Essen in the last 10 years

排除标准

  • no antiretroviral therapy / treatment

结局指标

主要结局

Frequencies of low-level viremia (LLV) during ART

时间窗: In the last 10 years

Viral loads between 40 and 1000 copies/ml at two consecutive time points preceded by undetectable viral loads

Frequencies of persistant viremia (PV) after start of ART

时间窗: In the last 10 years

Viral loads above 50 copies/ml 26 weeks after start of antiretroviral treatment

次要结局

  • Patterns associated with LLV or PV(In the last 10 years)
  • Detection of gag mutations(In the last 10 years)
  • HIV tropism during LLV or PV(In the last 10 years)
  • Cellular inflammation markers(In the last 10 years)

研究者

发起方
University Hospital, Essen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jens Verheyen

PD M.D.

University Hospital, Essen

研究点 (1)

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