Integral Research of the Managing and Treatment of the Infection With Human Immunodeficiency (VIH) /Human Immunodeficiency Syndrome(SIDA) Co-infection With Latent Tuberculosis Infection. A Multidisciplinary and Interinstitucional Approach
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Production of interferon gamma, in response to treatment of latent infection
研究概览
简要总结
The purpose of this study is to determine of once identified to the subjects infected with human immunodeficiency virus (positive VIH), to diagnose latent Tuberculosis, and to treat her with isoniazid for six months, measuring the production of Interferon range pre and posttreatment, to evaluate this way the result of the treatment on the immune response
详细描述
A descriptive analysis of the data will be made. Means and standard deviations for continuous data frequencies for categorical data will be performed. Wilcoxon test Mann-Whitney U test Chi square will be used for frequency analysis of responders Data Analysis and Statistical Software(STATA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Accept to participate. Informed consent.
- •Human Immunodeficiency Virus positive test, documented by Western Blot
- •Have not received treatment for latent tuberculosis
- •Have not been diagnosed pulmonary tuberculosis (Tbp)
- •Normal two chest X-rays, Postern-anterior and left lateral.
排除标准
- •Active tuberculosis
- •Previous diagnosis of tuberculosis
- •Antecedent of treatment for active o latent tuberculosis
- •Contact with TB patient harboring Multidrug resistance or isoniazid resistant isolates of Mycobacterium tuberculosis.
- •Abnormal liver enzyme levels
- •Hemoglobin below 8 gr/dl
- •Allergy or intolerance to isoniazid
- •Peripheral neuropathy
- •Ingestion of drugs interacting with isoniazid
研究组 & 干预措施
one arm
All patients with response to positive purified protein derivative (PPD) test are treated
干预措施: Isoniazid (Drug)
结局指标
主要结局
Production of interferon gamma, in response to treatment of latent infection
时间窗: Before and after treatment intake
次要结局
未报告次要终点
研究者
Ma. de Lourdes Garcia Garcia
Director of the Center of Research in Infectious Diseases
Instituto Nacional de Salud Publica, Mexico