Limiting HIV Target Cells by Inducing Immune Quiescence in the Female Genital Tract
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Changes in Systemic Immune Activation From Baseline Observed by the CD69 Expression on CD4 T Cells
研究概览
简要总结
In this project, the investigators want to analyse the capacity of Acetylsalicylic acid and hydoxychlroquin (HCQ) to induce an Immune Quiescence (IQ) phenotype, which has been previously associated with natural protection to HIV infection. This phenotype is characterized by lower expression of genes involved in cellular activation, lower resting levels of inflammatory cytokine production, lower level of systemic activated T cells, increased levels of systemic T regulatory, increased production of anti-viral anti-protease serpins at the female genital tract and reduced numbers of HIV target cells (mainly CD4+ CCR5+ T cells) in the FGT ( female genital tract).
The objective of this study is to determine if daily oral administration of Acetylsalicylic acid or hydroxychlroroquin can reduce systemic and mucosal immune activation in HIV negative women.
详细描述
The investigators will enrol 80 non female sex work low-risk HIV negative women and 80 HIV negative female sex worker HIV negative form Nairobi, Kenya and followed for a 3 months period.
During the first month, samples will be taken on a monthly basis
- blood,
- vaginal samples: cytobrush/scarper and cervico vaginal lavage (CVL). This is done to determine the baseline levels of systemic and mucosal immune activation of each woman. In this way, every women is acting as her own control thereby reducing variation between control and participant.
Chemokine/cytokine level, as well as cellular immune activation and T regulatory cells will be assessed.
At month two: the women will be divided in two different arms (oral administration of hydroxychloroquine: 200mg/day or Acetylsalicylic acid 81mg/day) and followed, on a monthly basis, for an 8 additional weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Acetylsalicylic Acid (ASA)
ASA 81 mg. p.o. daily for two months
干预措施: Acetylsalicylic Acid (ASA) (Drug)
Hydroxychloroquine (HCQ)
Hydroxychloroquine (HCQ) 200 mg. o.d. p.o. for two months.
干预措施: Hydroxychloroquine (HCQ) (Drug)
结局指标
主要结局
Changes in Systemic Immune Activation From Baseline Observed by the CD69 Expression on CD4 T Cells
时间窗: Baseline and 8 weeks
We will analyse reduce of immune activation by measuring change in T cell activation (CD69) between baseline and every month during drug administration phase (8 weeks).
次要结局
- Change in Number of CCR5+CD4+ T Cell Population at the Female Genital Tract.(baseline and 8 weeks)
研究者
Dr. Keith Fowke
Professor Department of Medical Microbiology
University of Manitoba