Functional Cure Study of HIV-infected Patients
Kaohsiung Medical University Chung-Ho Memorial Hospital Tropical Medicine Center
研究概览
详细说明
This study targets on this newly HIV- infected cohort and urging them to receive cART in order to achieve the possible status of HIV function cure. After 3~5 years period of treatment, cART will be discontinued after laboratory evaluation and functional cure is anticipated. These patients can achieve good life quality. In addition to elimination of the risk for HIV transmission, the cART expense of the government can be reduced on the large scale. The core of this study aims at setting up a precise and standard laboratory methodology for detecting the newly infected cases and predicting the time to stop cART. Once these assay methods are well established, they can be widely applied to assess the previous cases with long term cART for the prediction of the appropriate time to stop cART.
Thru the conventional HIV tests (within the sero-conversion stage), the detection rate of early infection is only 5-10 %. Therefore it is very desperately important to develop more tools for the diagnosis of early infection.
In addition to the standard method for detecting HIV infection, the investigators will use the HIV p24 Ag test and detuned Enzyme-linked Immunoblotting assay (EIA) assay for detecting early infection. For naïve patients, the investigators will also check the resistance testing for antiretroviral drugs in order to adjust and choose the susceptible cART for the patients. During the cART period, the investigators will follow up these patients for checking quantity of HIV RNA and proviral DNA (HIV DNA) from Peripheral blood mononuclear cell (PBMCs) in their blood. After three to five years of cART, if their HIV RNA is not detected and HIV DNA is very low, the investigators will draw the blood from the patients to isolate the Cluster of Differentiation 4 (CD4) receptors + T cells and co-cultivated with PBMCs from the healthy cohorts to evaluate the existence of HIV infectivity or not in the cART treated cases. If there is no infectivity, the investigators will stop cART. After stopping cART, the investigators will follow up these cases every six months till at least two years to check their HIV antibody, HIV RNA and HIV DNA from PBMCs to observe whether HIV recurrence occurs to them.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Kaohsiung、台湾、810
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- HIV
- Age over 20 years old to 35 years old.
Exclusion Criteria:
- Refuse to accept cases HAART
- Interruption of HAART cases during treatment.
- Can not rule taking HAART drugs, leading to treatment failure cases.
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Recent infection patient
The patient who infected with HIV-1 and screened out by P24 ELISA, and they would receives early cART course.
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The investigators would start regular cART course immediately for early infection patients to achieve functional cure.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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In ELISA format test cases contain the plasma p24 Ag
大体时间:3 to 5 years
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Test cases contain the plasma p24 antigen and Detuned assay for early to tell whether a dye.
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3 to 5 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Monitoring of functional cure
大体时间:every six months till at least two years
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After three to five years of cART, if the subjects's HIV RNA is not detected and HIV DNA is very low, the investigators would draw the blood from the subjects to isolate the CD4 + T cells and co-cultivated with PBMCs from the healthy cohorts to evaluate the existence of HIV infectivity or not in the subjects.
If there is no infectivity, the investigators would stop subjects's cART course.After stopping cART, the investigators would follow up these subjects every six months till at least two years to check their HIV antibody, HIV RNA and HIV DNA from PBMCs to observe whether HIV recurrence occurs to them.
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every six months till at least two years
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合作者和调查者
调查人员
- 首席研究员:Jih-Jin Tsai, PhD、Tropical Medicine Center (TMC), Kaohsiung Medicine University Hospital (KMUH)
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- KMUHIRB-20140058
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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