Effect of Routine Viral Load Monitoring on Clinical and Immunological Outcomes and Antiretroviral Drug Resistance on Patients Taking First-line Antiretroviral Drugs in Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- Death or new/recurrent AIDS-Defining (WHO Clinical Stage IV) Illnesses
研究概览
简要总结
The purpose of the study is to test the hypothesis that the addition of routine viral load testing to the standard laboratory monitoring of HIV patients on first-line antiretroviral treatment (ART) in Vietnam will result in better clinical outcomes for patients.
详细描述
The optimal strategy for monitoring antiretroviral therapy (ART) in resource-limited settings (RLS) is unknown. In developed countries, routine monitoring with CD4 count and viral load (VL) testing is standard practice. In RLS, however, limitations in the availability of the technology for VL testing, and in financial resources to pay for VL testing, mean that few developing countries provide VL testing as part of the routine monitoring of patients on ART. Instead, ART is monitored primary by clinical examination with CD4 testing where available. This strategy has been endorsed by the most recent WHO guidelines for ART (WHO, 2010).
Standard laboratory monitoring of patients on ART in Vietnam includes CD4 testing every 6 months, where available. In many rural areas of the country, CD4 testing is not available and only clinical monitoring is used.
In this study we will test the hypothesis that routine viral monitoring every 6 months for patients on first-line ART will result in significantly higher rates of virological suppression and decrease the incidence of death or new or recurrent AIDS-defining illnesses by 50% within three years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age >= 18
- •Confirmed HIV infection
- •Not currently taking ART
- •Meets Vietnam MOH criteria for ART (THROUGH OCTOBER 2011:CD4<250 cells/mm3, WHO Clinical Stage IV, or WHO clinical stage III with CD4<350 cells/mm3; FROM NOVEMBER 2011: CD4<350 cells/mm3, OR WHO Clinical Stage III or IV)
- •Completes required Vietnam MOH ART adherence training
- •Signs written informed consent form
排除标准
- •Any ART use within the previous 3 months
- •History of treatment failure on first-line ART or known resistance to first-line ART.
- •Unable or unwilling to give written informed consent
研究组 & 干预措施
Standard Monitoring
The patients in the standard monitoring arm will receive routine laboratory monitoring as provided to all patients in public HIV clinics in Vietnam, including CD4 count, complete blood count, and liver functions tests every 6 months.
干预措施: Standard Care (Other)
Virological Monitoring
The patients in the virological monitoring arm will have routine laboratory monitoring as in the standard monitoring arm and in addition will have a viral load test performed every 6 months while in treatment. The first test will be done 6 months after initiating ART.
干预措施: Virological Monitoring (Other)
结局指标
主要结局
Death or new/recurrent AIDS-Defining (WHO Clinical Stage IV) Illnesses
时间窗: 3 years
The number of deaths and/or new/recurrent WHO Clinical Stage IV clinical illnesses that occur over 3 years of follow-up in each group.
Virological Suppression
时间窗: 3 years
The percentage of patients in each group who are still on treatment at 3 years who have virological suppression, defined as an HIV viral load below the level of laboratory detection.
次要结局
- Time to identification and diagnosis of treatment failure.(3 years)
- Time from virological treatment failure to switch to second line ART.(3 years)
- Resistance mutations(3 years)
- Sensitivity and specificity of WHO criteria for treatment failure(3 years)
- Cost-benefit analysis(3 years)
研究者
Todd Pollack
Assistant Professor in Medicine, Part-time
Beth Israel Deaconess Medical Center