Feasibility Study of a Once Daily Antiretroviral Regimen in Vietnam (ANRS 1210 VIETAR)
Feasibility Study of a Once Daily Antiretroviral Regimen for HIV-Infected Patients With CD4 Below 200/mm3, in Hô Chi Minh City, Vietnam
研究概览
详细说明
Despite a high number of infected subjects (estimated of 250,000 at the end of 2004) and a rapid spread of HIV infection in Vietnam, the use of anti-retroviral therapy remains limited. However, access to care and treatment will be expanded in Vietnam in the next few years with the support of national and international organisations. ANRS 1210 study is the first pilot program using highly active antiretroviral therapy (HAART) to evaluate the efficacy and the tolerance of an antiretroviral therapy delivered to adults in an external system of medical care, in Ho Chi Minh City. This feasibility study has also the objective to evaluate the cause of treatment failures and to assess social and behavioural conditions of patients at different stages during the treatment.
The present study is an open trial with direct individual benefit. The chosen treatment is a once-daily administration of 3TC, ddI and Efavirenz delivered to HIV infected adults with a CD4 count below 200/mm3. The duration of the study is eighteen months with a main evaluation at six months. One hundred patients will be selected in outpatient consultation of Binh Trieu hospital and Tropical Diseases Hospital of Ho Chi Minh City. The main criteria of evaluation will be the immunological response at 6 months, opportunistic infection events and the proportion of patients undergoing a regular monitoring at 6 months. Viral response will be also appreciated but, for technical question, will not be a main criteria of the study.
Patients are also administered a questionnaire by a trained independent interviewer about adherence to treatment, mental well-being, housing and nutrition, drug and sexual behaviour, social support and disclosure in order to study the associations between sociobehavioural dimensions, adherence and viral load at two successive follow-up visits.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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-
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Ho Chi Minh City、越南
- Binh Trieu Hospital
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Ho Chi Minh City、越南
- Tropical Diseases 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:
- Man or woman over 18 years old
- HIV infected
- Written informed consent signed
- CD4 count lower than 200/mm3
- No previous antiretroviral treatment
- Weight over 45 kilos and/or body mass index over 16
- Karnofsky Index over or equal to 70 percent
Exclusion Criteria:
- Pregnant woman or woman without effective contraception
- Opportunistic infection compromising the realisation of the treatment
- Tumoral pathology
- Progressive psychiatric affection
- Previous history of peripheral neuropathy or pancreatitis
- Hemoglobin above 90 g/l
- PMN neutrophil above 1.0G/l
- Platelets above 50G/l
- Liver enzymes over 5 times the normal values
- Lipase and/or amylase over 2 times the normal values
- Prothrombin rate above 50 percent
- Plasmatic creatinine over 200 micromoles/l
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
CD4 lymphocyte count after HAART
大体时间:6 months
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6 months
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Evaluation of treatment failures causes
大体时间:12 months
|
12 months
|
Assessment of patients social and behavioral conditions at different stages during the treatment
大体时间:12 months
|
12 months
|
合作者和调查者
调查人员
- 学习椅:Jean Yves Follezou, Pr、CHU Pitié-Salpêtrière, Paris, France
- 首席研究员:Huu Chi Nguyen, Dr、Tropical Diseases Hospital - Ho Chi Minh City - Vietnam
研究记录日期
研究主要日期
学习开始
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 (估计)
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
其他相关的 MeSH 术语
其他研究编号
- ANRS 1210 VIETAR
- VIETAR
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