New And Recurrent Visceral Leishmaniasis in HIV Co-Infected Ethiopian Patients: a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- key host and pathogen factors of active chronicity in VL/HIV patients
研究概览
简要总结
The aim is (1) to better understand the underlying causes and predispositions for relapse and parasite persistence in visceral leishmaniasis (VL) patients living with HIV and (2) to improve treatment monitoring of this target group in Ethiopia
详细描述
Prospective and retrospective observational cohort study
Main objective
- To identify the key host and pathogen factors that contribute to active chronicity (=recurrent or chronic parasite presence in blood, tissue and/or skin in combination with clinical symptoms) in VL/HIV patients in northern Ethiopia
Specific objectives
- To describe the VL/HIV patients by level of chronicity using routine clinical and laboratory data
- To monitor parasite presence by molecular diagnostic in peripheral blood and - if available - tissue aspirates before, during, after treatment as well as during follow-up by level of disease chronicity
- To broadly characterize the underlying HIV co-infection and potential of ART resistance by level of disease chronicity
- To genotype the Leishmania parasites by level of disease chronicity to assess re-infection, recrudescence, drug resistance, and quiescence/virulence
- To identify other concomitant (latent) co-infections (TB, malaria, intestinal helminths, viral infections) and its impact on disease chronicity
- To study the level of exhaustion and immune checkpoint inhibition pathways, as potential therapy targets, by disease chronicity
- To assess the quality of life by a standardised questionnaire at admission and during follow-up
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •VL-HIV infection 1.
- •VL: microscopically confirmed parasite presence in spleen or bone marrow tissue at first episode or relapse; for known active chronic cases: decision to treat VL 1.
- •HIV: confirmed viral infection (new or past)
排除标准
- •Not willing to provide written informed consent
- •Not willing to adhere to the follow-up visits
- •Mentally or physically incapable to participate in the study (to the discretion of the treating physician)
结局指标
主要结局
key host and pathogen factors of active chronicity in VL/HIV patients
时间窗: 12 months
Descriptive analysis of key host and pathogen factors that contribute to active chronicity in VL/HIV patients in northern Ethiopia
次要结局
未报告次要终点