NCT05536466尚未招募不适用
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 8
- 主要终点
- AUC of doravirine
研究概览
简要总结
a multicentre phase IV study to collect evidence that a doravirine-based regimen can be safely and effectively administered to virologically suppressed HIV-infected patients undergoing bariatric suregery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected
- •VL suppressed <40c/ml for at least 6 months, blips are allowed
- •planned to have bariatric surgery (gastric bypass or gastric sleeve)
- •Able to sign informed consent
- •Age > or equal to 18 years
- •Using doravirine for at least 4 weeks prior to BS with VL < 40 copies/mL prior to the surgery
排除标准
- •History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study or interfere with the subject's participation
- •Requires or is anticipated to require any of the prohibited medications known to contradict/interact with doravirine
- •Has significant hypersensitivity or other contraindication to doravirine
- •Creatinine clearance <40 ml/min
- •Severe liver dysfunction (Diagnosed liver cirrhosis: Child-Pugh C)
- •Pregnancy or planning to be pregnant during first 6 months postbariatric surgery.
结局指标
主要结局
AUC of doravirine
时间窗: 24 hours
area under the curve, doravirine
次要结局
- HIV viral load(24 weeks)
- adverse events(24 weeks)
研究者
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