OBSERVATIONAL STUDY FOR THE EXTENDED FOLLOW-UP OF THE PATIENTS ENROLLED IN THE PHASE II THERAPEUTIC CLINICAL TRIAL ISS T-002
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 8
- 主要终点
- anti-Tat humoral immune response
研究概览
简要总结
An observational study to prospectively follow-up the patients enrolled in the ISS T-002 clinical trial up to 132 weeks. The primary endpoint of this study is to evaluate the persistence, in term of frequency, magnitude and quality, of the anti-Tat humoral and cellular immune response in the HIV-1 infected individuals who participated to the ISS T-002 and who have received at least 3 immunizations. The secondary endpoint is to define and validate novel laboratory tests for future efficacy clinical trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Previous participation in the ISS T-002 trial, having received at least 3 immunizations;
- •A follow-up of at least 48 weeks during the ISS T-002 study;
- •Availability to participate in the extended follow-up study;
- •Signed informed consent.
排除标准
- •The absence of any of the above criteria will exclude the subjects from the study.
结局指标
主要结局
anti-Tat humoral immune response
时间窗: Every 3 months, up to 2.5 years
The primary endpoint of the study is to evaluate the persistence, in term of frequency, magnitude, and quality of the anti-Tat humoral immune response in HAART-treated patients previously immunize with Tat in the ISS T-002 phase II clinical trial.
次要结局
- Testing of the additional Immunological parameters detailed below as a second line testing(Every 3 months, up to 2.5 years)
- Testing of virological parameters detailed below, as a second line testing(Every 3 months, up to 2.5 years)
研究者
Barbara Ensoli, MD, PhD
PhD
Istituto Superiore di Sanità