Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection: A Pilot Comparative Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Functional cure (Proportion of patients with undetectable viral reservoir)
研究概览
简要总结
Pilot study to evaluate the impact of extremely early ART in the dynamics of viral reservoir, immune activation and inflammation in patients with HIV-1 infection of less than 20 days (Fiebig stages I-II) compared to patients with infection of 20-100 days (Fiebig stages III-V), to induce HIV functional cure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men who have sex with men
- •Male's between18 and 65 years old
- •Less than 100 days of infection
- •Patient stage Fiebig I to V
- •Negative or Incomplete western blot with negative p31 band
排除标准
- •P31 positive band in western blot
- •Positive Delta32 CCR5 mutation, HLA-B5701 or HLA-B27 (´late' exclusion criteria)
- •Active oncological disease
- •Active hepatitis C virus infection
研究组 & 干预措施
Antiretroviral treatment
干预措施: Antiretroviral Therapy (Experimental) (Drug)
结局指标
主要结局
Functional cure (Proportion of patients with undetectable viral reservoir)
时间窗: 12 months of treatment
Proportion of patients in both groups with undetectable viral reservoir in peripheral and rectal tissue CD4+ T cells. A viral load will be performed at 1, 3 and 12 months after ART initiation and in rectal tissue at one year post-ART initiation.
次要结局
- Proportion of patients with undetectable plasmatic HIV viral load(1, 3 and 12 months post-stop antiretroviral treatment will be evaluated.)
- Level of reduction of inflammation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V(1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop)
- Level of reduction of viral reservoir among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V(1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop)
- Level of reduction of bacterial translocation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V(1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop)
- Level of reduction of immune activation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V(1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop)
研究者
David Garcia Cinca
Clinical Research Manager
Hospital Clinic of Barcelona