Dynamics of Viral Reservoir in HIV-positive Patients With or Without HCV Coinfection in the Era of Direct-acting Antiviral and Antiretroviral Drugs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Percentage of HIV-positive patients with a significant HIV-DNA decay after 3 years from a new antiretroviral regimen start
研究概览
简要总结
New markers of viral activity are now under investigation. Aim of the study is to investigate the efficacy of new antiretroviral drugs by monitoring HIV-DNA dynamics in HIV-positive population. In HIV/HCV coinfected population, the study of HIV reservoir dynamics and the analysis of the prevalence of HCV resistance-associated mutations will help clinicians to improve the management of coinfected patients.
详细描述
New markers of viral activity are now under investigation. Besides HIV-RNA and CD4 cells count, HIV-DNA is an emerging marker of viral reservoir, that seems to be associated with the risk of HIV-related diseases, especially in HCV coinfected patients. New antiretroviral drugs, particularly integrase inhibitors, are expected to decrease residual viremia and, consequently, viral reservoir. Monitoring of HIV-DNA dynamics during antiretroviral treatment could lead to a better management of HIV infected population.
Also, the role of HCV in influencing HIV natural history requires careful monitoring. In particular, with a broader use of direct acting antiretroviral, the analysis of prevalence of HCV resistance associated mutation will be more and more important to manage patients with treatment failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 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
- •Persons ≥ 18 years-old;
- •Signing an informed consent to study participation and data treatment;
- •HIV-positive patients, beginning a new antiretroviral treatment patients or with clinically relevant events;
- •HCV-positive patients beginning an antiviral treatment with DAA.
排除标准
- •Patient's deny
- •Clinical contraindications to blood sample withdrawal
结局指标
主要结局
Percentage of HIV-positive patients with a significant HIV-DNA decay after 3 years from a new antiretroviral regimen start
时间窗: up to 144 weeks
次要结局
- Prevalence of HCV resistance-associated variants and their relation with HIV-DNA levels in HIV/HCV coinfected patients, treated or not treated for HCV.(up to 144 weeks)
- Comparison of the prevalence of HCV resistance-associated variants in HIV/HCV coinfected population versus HCV monoinfected population(up to 144 weeks)
- Percentage of HIV/HCV coinfected patients with a significant HIV-DNA decay after 3 years from the enrollment(up to 144 weeks)
- Measurement of HIV-DNA level during HCV antiviral therapy with DAA in HIV/HCV coinfected patients(up to 24 weeks)
研究者
Simona Di Giambenedetto
Researcher
Catholic University of the Sacred Heart