Observational Study With Additional Diagnostic Procedures on Anti-Tat Immune Response in HIV-1-infected Asymptomatic Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 10
- 主要终点
- Specific humoral and cellular immune responses to Tat will be monitored by assessing anti-Tat specific antibodies in sera, proliferative response (CFSE) and production of γIFN, IL-4 and IL-2 (Elispot) by peripheral blood mononuclear cells.
研究概览
简要总结
The present study is designed as a prospective observational study directed at evaluating the frequency, magnitude, quality and persistence (primary endpoint) of the anti-Tat immune response in HIV-1 infected asymptomatic individuals, and to prospectively evaluate the immunological, virological and clinical outcome of anti-Tat positive versus anti-Tat negative drug naїve subjects (secondary endpoint) in order to determine the impact of anti-Tat immunity on HIV disease progression as well as the potential use of anti-Tat immune response assessment for the clinical and therapeutic management of infected patients. This survey provided important information for the design, planning and conduction of future therapeutic vaccine trials based on the HIV-1 Tat protein in asymptomatic subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •To be clinically asymptomatic HIV-1 infected individuals with CD4+ T cell counts ≥400/μL
- •To be naïve for antiretroviral therapy
- •Levels of plasma viremia ≤100,000 copies/ml at baseline
- •Age ≥ 18 years
- •Signed informed consent
排除标准
- •Current therapy with immunomodulators or immunosuppressive drugs or chemotherapy for neoplastic disorders
- •Concomitant treatment for HBV or HCV infection
结局指标
主要结局
Specific humoral and cellular immune responses to Tat will be monitored by assessing anti-Tat specific antibodies in sera, proliferative response (CFSE) and production of γIFN, IL-4 and IL-2 (Elispot) by peripheral blood mononuclear cells.
次要结局
- The decline of CD4+ T cells count, the increase of the HIV plasma viral load or the occurrence of AIDS-defining events will be assessed to determine the progression to disease
研究者
Barbara Ensoli, MD
PhD
Istituto Superiore di Sanità