Effect of Dolutegravir Intensification on Blood and Tissue Latent HIV-1 Reservoirs and on Residual Viremia Despite ART
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To evaluate the impact of treatment intensification at the level of total and replication-competent reservoir (RCR) in blood and in tissues.
研究概览
简要总结
Persistent HIV viremia occurs in most ART-treated patients and could arise from reactivation of viral expression from latently-infected cells that constitute the viral latent reservoir (LR) and/or residual ongoing viral replication during cART, for instance in anatomical compartment where drug penetration is sub-optimal.
The question of the sources of persistent viremia is of the utmost importance. If ongoing viral replication occurs, it could induce deleterious consequences on reservoirs size and immune activation.We propose to better characterize the role ongoing viral replication to HIV persistence under ART by undertaking a treatment intensification trial with high-dose dolutegravir. Tissue/blood samples and replication-competent reservoir measurements will be included as outcomes as well as immune activation markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •HIV-infected adults receiving cART for at least 3 years
- •Undetectable viral for at least 3 years
- •DTG/3TC/ABC as cART regimen in the previous 6 months.
- •CD4 counts higher than 200 cells per μL
排除标准
- •active hepatitis C or B
- •unstable liver disease
- •renal impairment (estimated glomerular filtration rate <50 mL per min),
- •gastrointestinal disorders that would affect the absorption of study treatment
- •current use of drugs with significant interactions with dolutegravir
- •current use of drugs with an impact on inflammation such as steroids.
- •hospitalization for acute illness within the previous 8 weeks
- •Pregnancy or breastfeeding.
- •Anal or rectal lesions impeding rectal biopsies
- •Decreased platelets count or coagulation disorder.
研究组 & 干预措施
Intensified
Group of patients whose treatment will be intensified with an additional 50mg of dolutegravir on top of regular treatment (Triumeq: ABC/3TC/DTG).
干预措施: Dolutegravir 50 MG (Drug)
结局指标
主要结局
To evaluate the impact of treatment intensification at the level of total and replication-competent reservoir (RCR) in blood and in tissues.
时间窗: 3 months
Measurements of blood and tissue HIV reservoir
次要结局
- To correlate the concentration of DTG with residual viremia and impact on HIV reservoir(3 months)
- To investigate the correlation between blood and tissues HIV reservoir(3 months)
- To evaluate the impact of DTG treatment intensification on immune activation(3 months)
- To evaluate the impact of DTG treatment intensification on inflammation(3 months)
- To evaluate the impact of DTG treatment intensification on residual viremia(3 months)
研究者
Gilles Darcis
Principal Investigator
University of Liege