A Pilot, Prospective, Non-randomized Study to Evaluate the Safety and Efficacy of Switches From Etravirine to Doravirine, in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Percentage of subjects who maintain virologic control .
研究概览
简要总结
This is a pilot, open, prospective, non-randomized study to evaluate the safety and efficacy of switches from etravirine to doravirine, in experienced patients with multiple class resistance including NNRTI resistance. The other ARV medication (protease inhibitor, entry inhibitor and integrase inhibitor) that some patients receive, in addition to the NRTI and NNRTI, will not be changed.
The study will be performed only on two sites
详细描述
The duration of the study will be of 120 weeks: 24 for recruitment and 96 weeks of follow-up. The reasons for the study duration of 2 years is that, up to now, doravirine has not been studied in 2 or 3 classes multi-drug-resistance (MDR) and thus, demonstration of durability of effect over a prolonged period of time is as important as the short-term efficacy.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (18 Y.O. or more) women and men infected with HIV.
- •Treated with etravirine and at least 2 others ARV in the other classes: NRTI, PI, INSTI, EI, for at least 12 months.
- •Virologically controlled (HIV-1 RNA < 50 copies/mL) since at least 6 months. Blips (HIV-ARN ≥ 50 copies/mL, one time, with return to virologic control at the next visit) are allowed.
- •Presence of at least one major NNRTI mutation.
- •No limitation on the number of previous regimens.
- •HCV and HBV-infected patients are allowed
排除标准
- •High level of resistance to doravirine according to historical resistance tests.
- •Level of resistance to doravirine superior to that of etravirine
- •Opportunistic or serious active infection or disease
- •Active and untreated malignancy.
- •Current psychiatric or neurocognitive condition judged by the Investigator to potentially interfere with study visits and procedures
- •Pregnancy.
- •Active treatment for hepatitis C is forbidden at entry but will be allowed after 3
研究组 & 干预措施
switch from etravirine to doravirine
switches to doravirine,
干预措施: Doravirine (Drug)
结局指标
主要结局
Percentage of subjects who maintain virologic control .
时间窗: 24 weeks
Virologic control is defined by measurement of HIV-1 RNA \< 50 copies/mL.
次要结局
未报告次要终点
研究者
Benoit Trottier
Dr Benoit Trottier Principal Investigator
Clinique du Quartier Latin