Initiation of a Once Daily Regimen of Tenofovir, Lamivudine and Efavirenz After 4 Weeks Versus 12 Weeks of Tuberculosis Treatment in HIV-1 Infected Patients (Time Study)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- death rate
研究概览
简要总结
To study the optimal timing to initiate antiretroviral therapy in HIV-infected patients who are receiving tuberculosis treatment between at 4 weeks and at 12 weeks after tuberculosis treatment by comparing the composite end point of death rate, hospitalization rate and adverse drug reactions at week 48, 96 and 144.
详细描述
The growing epidemic of HIV poses a serious public health threat in many countries, including Thailand. Mortality is clearly reduced in HIV and tuberculosis (TB) co-infected patients who initiate antiretroviral therapy (ART) after the treatment of TB, but the optimal timing to initiate ART is one of the major concern for patients concurrently receiving both therapies. To date, the prospective, randomized, control trial to study the optimal timing to initiate ART in the patients is still limited. In addition, the current recommendation to start ART in patients co-infected with HIV and TB is still based on expert opinions. Here, the investigators plan to investigate the optimal timing to initiate antiretroviral therapy in HIV-infected patients who are receiving tuberculosis treatment between at 4 weeks and at 12 weeks after tuberculosis treatment by comparing the composite end point of death rate, hospitalization rate and adverse drug reactions at week 48, 96 and 144 at Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, Thailand.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years of age
- •HIV-1 infected patients
- •Naïve to antiretroviral treatment
- •Baseline CD4 cell count <350 cells/mm3 at enrolment
- •Diagnosed as having active tuberculosis by clinical features or positive acid fast stain or positive TB culture; and receiving rifampicin containing antituberculous regimen
- •Signed inform consent
排除标准
- •Serum transaminase enzymes ≥ 5 times of upper normal limit or total bilirubin ≥ 3 times of upper normal limit
- •Serum creatinine ≥ 2 times of upper normal limit
- •Lactation or pregnancy
- •Receiving any immunosuppressive agents
研究组 & 干预措施
start antiretroviral treatment
the optimal timing to initiate antiretroviral therapy in HIV-infected patients who are receiving tuberculosis treatment between at 4 weeks and at 12 weeks after tuberculosis treatment
干预措施: tenofovir, lamivudine, efavirenz (Drug)
结局指标
主要结局
death rate
时间窗: 48 weeeks
次要结局
- hospitalization(48 weeks)
- adverse events(48 weeks)
- composite endpoint of a. death b. hospitalization and c. adverse event(48 weeks)
- TB IRIS(48 weeks)
- Risk of death(48 weeks)