Clinical Implications of HIV Low-level Viremia at Times of Highly Active Antiretroviral Treatment Regimens
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
- 否
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
Jens Verheyen
PD M.D.
University Hospital, Essen
