Predicting Visceral Leishmaniasis in HIV Infected Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 566
- 试验地点
- 1
- 主要终点
- Incidence rate of active VL
研究概览
简要总结
In this cohort study, the investigators will study the asymptomatic period preceding the onset of active Visceral Leishmaniasis (VL) in HIV-infected individuals from VL endemic regions in Ethiopia as an avenue to develop an evidence-based screen and treat strategy to prevent progression to active VL.
详细描述
HIV co-infection drastically increases the risk of developing active VL. Clinical outcomes are dire in immune-compromised patients even with the best available treatment, and relapse is frequent. The incubation period may provide an important window of opportunity for a pre-emptive "screen an treat" approach in HIV co-infected patients to prevent progression from infection to the active disease. However, no recommendations exist to date due to lack of solid evidence.
It is not known which patients are at highest risk of disease progression, which role parasite/host/HIV factors play in the asymptomatic infection phase, and what the diagnostic values of existing Leishmania infection markers are. Such information is needed to develop a prognostic clinical tool for the detection of HIV patients at high risk of developing active VL.
Therefore, the aim is to study the asymptomatic period preceding the onset of active VL in HIV-infected individuals from VL endemic regions in Ethiopia as an avenue to develop an evidence-based screen and treat strategy to prevent progression to active VL. This will be a prospective cohort study with one year of follow-up for patients who remain VL free. Patients developing active VL during the study period will be followed until the end of the study duration.
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
- •Confirmed HIV-positive
- •Enrolled in HIV care at the study site
排除标准
- •Age under 18 years
- •Diagnosis of active Visceral Leishmaniasis at enrolment
- •Unlikely to seek health care again at this site during the next two years
- •Not able or willing to provide informed consent. For patients not able to provide informed consent: No guardian available or willing to provide IC
- •Medical emergency, underlying chronic medical condition, or other circumstances that make adherence to the study unlikely, or participation in the study medically inadvisable.
结局指标
主要结局
Incidence rate of active VL
时间窗: January 2020
The number of individuals who develop active VL per person-years at risk during follow-up, among all enrolled participants
Prognostic tool for active VL
时间窗: January 2021
A clinical decision algorithm, prioritizing and integrating identified risk factors, that is able to most efficiently predict the risk of developing active VL within 12 months
Incidence rate of asymptomatic Leishmania infection
时间窗: January 2020
The number of individuals with newly diagnosed asymptomatic Leishmania infection per person-years at risk during follow-up, among participants without Leishmania infection at enrolment
Prevalence of asymptomatic Leishmania infection
时间窗: January 2018
The proportion of individuals with asymptomatic Leishmania infection at enrolment, among all enrolled participants
Evolution of Leishmania infection markers
时间窗: January 2020
The proportions of individuals with positive test results for the different Leishmania infection markers at each follow-up visit
Risk factors for active VL
时间窗: January 2020
The association between the risk to develop active VL during follow-up and demographic/clinical characteristics as well as HIV/host immunity/Leishmania infection markers from baseline onwards
次要结局
- Patterns in host immune markers for asymptomatic Leishmania infection(January 2020)
- Patterns in host immune markers for VL treatment failure(January 2021)
- Evolution of host immune markers(January 2020)
- Patterns in host immune markers for VL relapse(January 2021)