Effect of Active Hexose Correlated Compound to Clinical and Immunological Response in Tuberculosis-HIV (Human Immunodeficiency Virus) Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Sputum Conversion Duration
研究概览
简要总结
Background
Active Hexose Correlated Compound is assumed to have a positive effect on immunity, including induce a phagocytic response, reduce tumor resistance, and cytokine response including interferon-gamma and interleukins. Tuberculosis patients with concurrent Human immunodeficiency Virus (HIV) might have benefit when receiving active hexose compound during tuberculosis treatment
Purposes
- To assess the clinical changes of patients who receive active hexose compound as an adjuvant to tuberculosis therapy in patients with HIV
- To assess the difference of pro-inflammatory cytokines between standard therapy and active hexose compound adjuvant
Methods A clinical trial involving patients with Tuberculosis-HIV infection
Hypothesis
- Clinical improvement is significantly different where the group who receive active compound will have the better clinical outcome
- Lower proinflammatory cytokines are observed in people who receive active compound
详细描述
Population :
Lung Tuberculosis patient with HIV Infection
Design :
Double-Blind Randomized Control Trial at the outpatient setting
Randomization Simple Randomization
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigator will be blinded from the allocation (not allowed to observe the allocation and intervention) and the outcome assessor will not be informed the code of allocation
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
- •Newly-diagnosed Lung Tuberculosis case who will receive a 6-month regiment
- •Not Pregnant
- •Diagnosed with HIV
排除标准
- •Patient with liver dysfunction
- •Patient with drug-resistant
- •Severe Malnutrition
- •Refuse to be involved
结局指标
主要结局
Sputum Conversion Duration
时间窗: six month after the intervention started
Sputum conversion duration defined as the duration to change positive result in sputum smear into negative results. The sputum smear level using Ziehl Neelsen ranging from Negative to 3+.
Chest X-Ray Extension
时间窗: Changes of number of active tuberculosis feature from baseline to 6 months
Distribution of active tuberculosis feature in Chest X-Ray including number of consolidation and cavitation
Interleukin 6 Level
时间窗: Changes of Interleukin 6 Level from baseline to 6 months
Value of Interleukin 6 in blood Sample
Interleukin 10 Level
时间窗: Changes of Interleukin 10 value from baseline to 6 months
Value of Interleukin 10 in blood Sample
次要结局
- Cluster Differentiation 8 (CD8) cells value(Changes of Cluster Differentiation 8 (CD8) cells value from baseline to 6 months)
- Cluster Differentiation 4 (CD4) cells value(Changes of Cluster Differentiation 4 (CD4) cells value from baseline to 6 months)
研究者
Bumi Herman
Assistant Lecturer
Hasanuddin University