NCT03940521进行中（未招募）不适用
Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年9月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Percentage of CD4+ T cells expressing X alone
研究概览
简要总结
The authors hypothesize that there is a correlation between the percentage of CD4+ T cells expressing CD32a and/or X and the quantity of DNA found in peripheral blood mononuclear cells in patients infected with HIV-1. Also, that there is a correlation between expression of CD32a and/or X and proviral load.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patient infected with aviremic HIV-1 (<20 copies of HIV-1 RNA/ml plasma) undergoing antiretroviral treatment for at least 2 years
- •Patient has known duration of infection and treatment
- •Patient has known pretherapeutic CD4+ T cell count and viremia
- •Patient has known CD4+ T cell count, residual viremia and CD4/CD8 ratio for previous 2 years
- •Patient weighs at least 56kg
- •The patient is not opposed to their inclusion in the study
- •The patient must be a member or beneficiary of a health insurance plan
- •Patient at least 18 years old
排除标准
- •Patient has an acute infection
- •The subject has already been included in the study or is in a period of exclusion determined by a previous study
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •Patient is pregnant, parturient or breastfeeding
结局指标
主要结局
Percentage of CD4+ T cells expressing X alone
时间窗: Day 0
%
Percentage of CD4+ T cells expressing both CD32 and X
时间窗: Day 0
%
Quantification of proviral load
时间窗: Day 0
Quantitative PCR; number of copies of HIV-1 DNA per million peripheral blood mononuclear cells
Percentage of CD4+ T cells expressing CD32 alone
时间窗: Day 0
%
次要结局
- Change in CD4+ T cells during treatment(Day 0)
- Viremia during the 2 previous years(Day 0)
- Testing for intact proviral DNA(Day 0)
- Duration of treatment(Day 0)
- Year treatment commenced(Day 0)
- Pre-therapeutic viremia(Day 0)
- Co-infection with hepatitis C virus(Day 0)
- Circulating viral RNA sequence(Day 0)
- Residual immune activation at inclusion into the study(Day 0)
- Residual immune activation during the previous 2 years(Day 0)
- Pre-therapeutic CD4 + T cell count(Day 0)
- Change in CD4+ T cells over previous 2 years(Day 0)
- Change in CD4+ T cells prior to treatment(Day 0)
- Duration of infection prior to treatment(Day 0)
- Viremia at inclusion into the study(Day 0)
- Co-infection with Cytomegalovirus(Day 0)
- Nature of current treatment(Day 0)
- Co-infection with hepatitis B virus(Day 0)
- Co-infection with Epstein-Barr virus(Day 0)
研究者
研究点 (1)
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