A Prospective Cohort for ex Vivo Cure Studies With Chronic HIV Infected Patients in the Netherlands: The CHRONO Project
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- To develop a prospective cohort in the Netherlands of chronic HIV infected patients within-depth reservoir characterization for future cure interventions.
研究概览
简要总结
A prospective non-interventional cohort study at Erasmus MC of adult chronic HIV infected patients of ≥18 years of age who initiate antiretroviral therapy in routine care.
详细描述
HIV cannot be cured with the current treatment armamentarium. A reservoir of latently HIV infected long lived CD4+T-cells is present in patients with HIV that are not affected by antiretroviral therapy. The evolution of this reservoir after therapy initiation is ill understood, as are the potential strategies to eradicate this reservoir. This study aims to anticipate on future HIV cure strategies by building a cohort to study ex vivo the reservoirs of HIV patients, the obstacles to cure HIV, and new therapeutic compounds and strategies.
Main study parameters/endpoints:
- Change in viral reservoir size after antiretroviral treatment initiation.
- Evolution of phenotypical and functional aspects of the anti-HIV host immune responses.
- Ex vivo activity of established and novel HIV latency reversing agents.
- Variance in HIV reservoir and host immunity between HIV subtypes and clinical variables.
A project from the Erasmus MC HIV Eradication Group (EHEG).
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
- •Age >18 years.
- •Confirmed HIV-1 or HIV-2 infection
- •Judged willing to initiate and adhere to cART by the HIV physician.
排除标准
- •Inability to place venous catheters to draw blood.
- •Major comorbidities:
- •Severe symptomatic anemia or recent symptomatic cardiovascular event (un-stable angina pectoris, decompensated heart failure, myocardial infarction).
- •The inability to participate due to any other relevant social, environmental,psychological, factors or according to the HIV treating physician's judgement.
结局指标
主要结局
To develop a prospective cohort in the Netherlands of chronic HIV infected patients within-depth reservoir characterization for future cure interventions.
时间窗: 5-10 years
The HIV latent reservoir will be characterised in chronic HIV patients using novel techniques like FISH-flow
To study the evolution of the HIV reservoir and immune host responses over time during antiretroviral therapy.
时间窗: 5-10 years
The HIV reservoir will be characterised over time to study the dynamics of the reservoir
次要结局
- To compare and validate new reservoir assays with current established assays.(5-10 years)
- To explore established and putative new interventions aimed at curing HIV.(5-10 years)
- To explore differences in reservoir size, activity and host responses, and their relation with clinical characteristics, between patients with different dominant HIV subtypes and sexes.(5-10 years)
研究者
Casper Rokx
Principal Investigator
Erasmus Medical Center