NCT02839603终止不适用
Asymptomatic Leishmania Infection and Burden of Visceral Leishmaniasis in HIV-infected Individuals in North West Ethiopia: a Pilot Study
Institute of Tropical Medicine, Belgium1 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2015年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- The proportion of individuals with L.donovani asymptomatic infection at baseline in HIV coinfected adults enrolled in HIV care in a VL-HIV endemic region in North-West Ethiopia.
研究概览
简要总结
To collect pilot data on the prevalence and incidence of asymptomatic Leishmania donovani infection in HIV infected individuals in a visceral leishmaniasis (VL)-HIV endemic region to inform the feasibility of a larger study exploring a screen and treat strategy for VL in HIV co-infected individuals in East-Africa (Ethiopia).
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
- •HIV infection
- •without a history of VL in the last 5 years
- •stable residents of a VL-endemic area
- •willing to participate and giving free informed consent
排除标准
- •younger than 18 years
结局指标
主要结局
The proportion of individuals with L.donovani asymptomatic infection at baseline in HIV coinfected adults enrolled in HIV care in a VL-HIV endemic region in North-West Ethiopia.
时间窗: End of study (2 years)
Proportion of individuals with asymptomatic infection, defined as positivity on any of the leishmanial markers (PCR, urine antigen or serology)
次要结局
- Proportion of asymptomatic infected patients in clinical determinant groups.(End of study (2 years))
- Proportion of baseline asymptomatic infected patients, with positive infection status for each baseline leishmanial marker at 3, 6, 9 and 12 months(3, 6, 9 and 12 months of follow-up)
- Total proportion of baseline asymptomatic infected patients, with positive infection status at 3, 6, 9 and 12 months follow-up.(3, 6, 9 and 12 months of follow-up)
- The proportion of individuals with asymptomatic infection during follow-up in HIV coinfected adults enrolled in HIV care in a VL-HIV endemic region in North-West Ethiopia(End of study (2 years))
- Proportion of individuals developing VL within the following year (= One-year risk of VL)(End of study (2 years))
- Proportions of individuals with a positive test on a specific leishmanial marker to describe the pattern of asymptomatic infection.(End of study (2 years))
研究者
研究点 (1)
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