Randomized Clinical Trial to Determine the Most Appropriate Time to Start HIV Treatment in HIV & TB Coinfected Adults Being Treated for Tuberculosis.
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- mortality
研究概览
简要总结
Aim of the study is to determine optimal time to initiate anti-retroviral therapy in HIV/TB co-infected patients who recently started treatment for Tuberculosis by comparing immediate versus deferred initiation of HAART.
The study will address the following questions;
- Is it possible to reduce mortality rate and increase survival by early initiation of HAART during TB treatment with out compromising for adverse drug reaction, toxicity and immune reconstitution syndrome?
- What is the risk/ benefit ratio between immediate versus deferred initiation of HAART during TB treatment with respect to safety/efficacy of TB and HIV co-treatment?
- When is the most appropriate time to start HAART during TB treatment?
详细描述
The study intends to determine the optimal time to start ART by comparing three treatment strategies of ART initiation in HIV/TB co-infected patients. Four hundred fifty newly diagnosed HIV infected patients with active TB and CD4 cell count < 200 cells/mm3 will be prospectively recruited to be assigned randomly in parallel into one of the three treatment groups (n=150 in each group) and HAART will be started at different time points as described below with extensive counseling and adherence support.
- Arm-A (Immediate Treatment Group): Receipt of antiretroviral therapy one week after starting anti-TB treatment.
- Arm-B (Deferred Treatment Group-1): Antiretroviral therapy will be initiated at the 4th week of starting anti-TB treatment (in the middle of the intensive phase TB treatment).
- Arm-C (Deferred Treatment Group-2): Antiretroviral therapy will be initiated at the 8th week of starting anti-TB treatment (after completion of the intensive phase of TB treatment).
Study Design: Interventional, prospective, randomized, open-label three-armed trial with no placebo, Active control, parallel assignment, safety and efficacy study.
Study population: Previously untreated HIV-infected adult patients with TB and CD4 cell counts < 200/mm3 at the time of TB diagnosis.
Expected Total Enrollment = 450
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed ART naive HIV infected patients and age > 18 years old
- •Newly diagnosed smear +ve PTB cases (abnormal CXR and at least one sputum sample +ve for AFB)
- •Newly diagnosed smear -ve PTB cases (CXR consistent with active TB plus at least two sputum specimens negative for AFB and decision by the physician to treat for TB or smear negative for AFB but culture positive cases)
- •Tissue biopsy or FNAC results consistent with the diagnosis of tuberculosis
- •CD4 cell count < 200/mm3 at the time of TB diagnosis
- •Residence in Addis Ababa, Ethiopia
- •Ability to give signed written/thumb sign informed consent
排除标准
- •Pregnancy and breast-feeding women
- •Patients who received anti TB therapy with in the past two years
- •Patients who have previous treatment experience with antiretroviral therapy
- •Severely ill patients Karnofsky performance status score < 40
- •Baseline Hgb < 8 gms/dL
结局指标
主要结局
mortality
时间窗: 24 weeks
all cause mortality
次要结局
- Tuberculosis-Immune Reconstitution Inflammatory Syndrome(24 weeks)
- New AIDS defining clinical events(24 weeks)
- Drug Induced Liver toxicity(24 weeks)
- Virologic success(24 weeks)