A Pilot Study to Evaluate the Feasibility of Identifying, Enrolling and Following Acute and Early HIV-1 Infected Individuals.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To measure the number of individuals who are Genexpert HIV Viral load assay positive and Alere Determine HIV-1/2 Negative.
研究概览
简要总结
It is only between peak viremia and viral setpoint in natural acute HIV-1 infection that the immune response overwhelms viral replication resulting in a plasma viral load decline. The aim will be to characterize these immune responses, how they develop and their progeny. This will require the need to identify HIV-1 infected individuals before peak viremia and follow them to post viral setpoint.
This protocol describes a pilot study to evaluate the feasibility of identifying, enrolling and following acute and early HIV-1 infected individuals from voluntary counselling and testing centres in Masaka, Bukomansimbi, Kalungu, Lwengo, Sembababule and Lyantonde districts.
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
- •Females and males.
- •Able and willing to provide informed consent.
- •Willing to undergo HIV testing using GeneX pert Viral Load assay.
- •Able and willing to provide accurate locator information for tracking purposes and willing to be contacted by study staff.
- •Willing to complete interviewer administered questionnaires on risk factors and if infected, questions related to the route and timing of exposure.
排除标准
- •Has any condition that in the opinion of the principal investigator or designee, would preclude provision of informed consent, or otherwise interfere with achieving the study objectives.
- •Participation in a current clinical trial unless approved by the investigators and IAVI medical monitor.
结局指标
主要结局
To measure the number of individuals who are Genexpert HIV Viral load assay positive and Alere Determine HIV-1/2 Negative.
时间窗: 12 months
次要结局
未报告次要终点
研究者
Dr. Andrew Obuku
SCIENTIST
MRC/UVRI and LSHTM Uganda Research Unit