NCT01878279已完成不适用
Longitudinal Study to Evaluate the Frequency of HSV-1 Oral Reactivation in Children in Dar es Salaam, Tanzania
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- HSV detection rate
研究概览
简要总结
In the proposed study, the investigators will carry out novel research to evaluate both symptomatic and asymptomatic daily oral herpes simplex virus (HSV) shedding rates and copy number in children with and without HIV.
Study Objectives:
- To evaluate the frequency of oral HSV reactivation in HIV-infected and uninfected children
Secondary Objectives: 2. To determine the acceptability of performing daily oral swabs in children age 3-12
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
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age > 3 and ≤12 years old
- •parental/guardian consent and children's assent must be obtained and participants and parent/guardian must be able to comply with study procedures
- •For HIV-infected group: Positive HIV serology by either ELISA x 2, ELISA + WB or PCR testing
排除标准
- •age <3 and > 12 years old
- •Acute illness which by opinion of the investigator makes enrollment in the trial unfeasible (including active tuberculosis, malaria or other opportunistic infection requiring treatment)
- •co-enrollment in other therapeutic/intervention trials (observational trial enrollment is permitted).
- •Stable co-administration of other medications is permitted (e.g. bactrim)
- •For HIV-infected children; receiving or eligible for antiretroviral (ART) therapy by local standards
结局指标
主要结局
HSV detection rate
时间窗: 14 days
次要结局
- HSV copy number(14 days)
研究者
研究点 (1)
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