Study to Compare Three Existing Starting Points of ART Initiation in HIV/TB Co-infected Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 642
- 试验地点
- 1
- 主要终点
- To measure the incidence of progression to AIDS defining illness or mortality
研究概览
简要总结
This is a randomized, open-label study comparing three existing treatment strategies of ART initiation in HIV/TB co-infected patients:
Group 1: early initiation of ART with TB treatment, Group 2: initiation of ART upon completion of the intensive phase of TB treatment, Group 3: initiation of ART upon completion of the continuation phase of TB treatment
Approximately 700 men and women ≥ 18 years of age with documented HIV infection and smear-positive pulmonary TB patients will be enrolled. Eligible TB/HIV co-infected patients will be offered antiretroviral therapy (ART), starting at one of the three time points listed above through the CAPRISA AIDS treatment programme which includes extensive counselling and adherence support. The study participants will be followed for 18 months to assess the primary study endpoint of the optimal time to start antiretroviral therapy (ART) in patients on tuberculosis (TB) treatment by comparing clinical status (CD4+ cell count, viral load, opportunistic infections.
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
- •HIV infected patients co-infected with TB
- •Receiving any one of the standard anti-TB therapy regimens
- •All patients must agree to use contraception since they will be on efavirenz.
排除标准
- •Entry into the treatment programme is based on a clinical assessment and should patients not be clinically eligible to maintain a treatment regimen,their entry may be deferred or precluded
研究组 & 干预措施
1 - Early integrated-therapy group
antiretroviral therapy to be initiated within 4 weeks of starting tuberculosis treatment
干预措施: Early versus intermediate versus late initiation of ART (Drug)
2 - Late integrated-therapy group
antiretroviral therapy to be initiated within 4 weeks of completing the intensive phase of tuberculosis treatment
干预措施: Early versus intermediate versus late initiation of ART (Drug)
3 - Sequential-therapy group
Antiretroviral therapy to be initiated within 4 weeks after completing tuberculosis treatment
干预措施: Early versus intermediate versus late initiation of ART (Drug)
结局指标
主要结局
To measure the incidence of progression to AIDS defining illness or mortality
时间窗: 18 months
次要结局
- A comparison of CD4+ cell count, viral load, opportunistic infections across the 3 study arms(18 months)