Host Response to Tuberculosis and Acquired Immune Deficiency Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Sputum Conversion
研究概览
简要总结
This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.
详细描述
BACKGROUND:
Mtb infects one-third of the world's population and ranks seventh in terms of global morbidity and mortality. Patients with bilateral pulmonary tuberculosis (TB), cavitary disease, and persistently positive sputum smears pose a special risk for treatment failure and/or relapse.
DESIGN NARRATIVE:
Cavitary pulmonary TB will be studied and interferon-gamma will be used as the intervention. The outcome of this study will be the changes in mycobacteriology, chest radiography, and bronchoalveolar lavage (BAL) cells.
The primary outcome will be sputum conversion, which will be measured at Weeks 4 and 8.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive acid-fast bacillus (AFB) smear within 14 days prior to randomization
- •Cluster of Differentiation 4 greater than 200 if HIV positive
- •Ability to sign consent
- •Bilateral, cavitary pulmonary TB
排除标准
- •Multidrug-resistant (MDR) TB
- •Extrapulmonary TB
- •HIV positive with opportunistic infection within 30 days of study entry
- •Pregnant or lactating women
- •Chronic heart disease
- •Chronic liver disease
- •Chronic renal disease
- •Seizure disorder
- •Bleeding or clotting disorder
- •Diabetes mellitus
研究组 & 干预措施
Standard Treatment
Isoniazid, Rifampin, Pyrazinamide Anti-Tuberculous Therapy
干预措施: Placebo (Other)
Aerosol Interferon-gamma
Aerosol Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide
干预措施: Aerosol Interferon-Gamma (Drug)
Subcutaneous Interferon-Gamma
Subcutaneous Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide
干预措施: Subcutaneous interferon-gamma (Drug)
结局指标
主要结局
Sputum Conversion
时间窗: Measured at 16 Weeks
次要结局
- Chest Cavity Size(16 Weeks)
- Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels(16 Weeks)