Beta-2 Microglobulin and Serum Cytokines as Indicators of Antiretroviral Therapy Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- To assess the behavior of Beta-2 microglobulin as indicator of highly active antiretroviral therapy (HAART) failure.
研究概览
简要总结
Cross-sectional study to assess the behavior of Beta-2 microglobulin and serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure.
详细描述
Objective
To assess the behavior of Beta-2 microglobulin and serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure Design: Cross-sectional study. Methods: Eighty-nine HIV-1+ patients and 20 normal individuals were divided into 4 groups: G1- 15 HIV-1+ individuals, previously untreated or without HAART for at least six months and CD4+ < 350 cells/mm3; G2- 31 HIV-1+ individuals undergoing HAART without virological therapeutic failure (TF), G3- 43 HIV-1+ individuals undergoing HAART with TF, and GC- 20 normal individuals who served as controls for serum cytokines. Demographic, clinical and HAART data were reviewed, and Beta-2 microglobulin, serum cytokines (TNF-α, IFN-γ, IL-2, IL-4 and IL-10), HIV-1 genotyping, plasma viral load and CD4+ and CD8+ lymphocytes tests were performed.
Key words: Beta-2 microglobulin, serum cytokines, HIV-1, resistance, HAART, therapeutic failure, genotyping.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV-1-infected individuals
- •Over 18 years old
- •Sign the "written consent form" (WCF)
排除标准
- •Do not presenting other immunosuppression causes, such as neoplasias, transplantations
- •Do not presenting treatment by immunosuppressive substances
- •Do not presenting auto-immune diseases
- •Not be using any type of immunostimulating substances
- •Not at any time of gestation
结局指标
主要结局
To assess the behavior of Beta-2 microglobulin as indicator of highly active antiretroviral therapy (HAART) failure.
时间窗: At subject enrollment.
次要结局
- To assess the behavior of serum cytokines TNF-α, IFN-γ, IL-2, IL-4 and IL-10 as indicators of highly active antiretroviral therapy (HAART) failure.(At subject enrollment.)