Impact of DOlutegravir+Lamivudine Simplification on TIssue and Blood Latent Replication-competent HIV-1 Reservoirs (IDOLTIB Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of replication-competent reservoir (RCR) in blood and in tissues.
研究概览
简要总结
For a few years, there has been a keen interest of clinicians and patients for "lighter" antiretroviral strategies based on two- or even single drug regimens rather than the canonical triple therapy, both as initial and maintenance therapy, despite the possibility that ongoing viral replication may occur in some patients under triple-therapy.
We will therefore propose such simplification strategy (DTG/3TC) while maintaining triple-therapy (DTG/ABC/3TC) in a control group and will perform an in depth analysis of the replication-competent reservoir in blood and in tissues as well as measurements of residual viremia and immune chronic activation/inflammation.
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 2 years
- •DTG/3TC/ABC as cART regimen in the previous 6 months.
- •CD4 counts higher than 200 cells per μL and virological suppression for at least 2 years (plasma HIV RNA <20 copies per mL)
排除标准
- •hepatitis C or B co-infection
- •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.
- •Known resistance to DTG or 3TC
- •Active tuberculosis
- •Anal or rectal lesions impeding rectal biopsies
- •Decreased platelets count or coagulation disorder.
研究组 & 干预措施
2DR
Switch from 3 drug regimen (DTG+ABC+3TC) to 2 drug regimen (DTG+3TC)
干预措施: Treatment simplification (dolutegravir lamivudine) (Drug)
结局指标
主要结局
The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of replication-competent reservoir (RCR) in blood and in tissues.
时间窗: 1 year
Measurements of RCR in the blood and tissues (rectal biopsies)
次要结局
- The correlation between the size of the blood/tissues RCR and the level of chronic immune activation/inflammation.(1 year)
- The level of clonal expansion in the blood and tissue RCR(1 year)
- The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) on residual viremia.(1 year)
- The correlation between blood and tissues RCR in a high number of patients under suppressive antiretroviral therapy.(1 year)
- The impact of dual-therapy Dolutegravir (DTG) + Lamivudine (3TC) at the level of chronic immune activation/inflammation.(1 year)
研究者
Gilles Darcis
Head of clinic
University of Liege