NCT04166474已完成4 期
Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in pharmacokinetic parameter Cmin of dolutegravir
研究概览
简要总结
This is a drug interaction study in HIV negative, TB-monoinfected participants coming to the end of continuation phase of TB therapy, to study the pharmacokinetic changes to dolutegravir when administered with standard, medium and high dose rifampicin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Ability to give informed consent prior to participation
- •Willing and able to comply with all study requirements
- •Receiving standard doses of RIF and INH
- •HIV antibody negative
- •Male or non-pregnant, non-breastfeeding female
- •Study participation will not extend length of ATT by more than 4 weeks
排除标准
- •< 18 years
- •Body weight < 50 kg
- •eGFR < 60 mL/min
- •Abnormal LFTs including ALT > 2.5 ULN
- •HIV antibody positive
- •Non-standard TB regimen (containing RHZE)
- •Women of childbearing age unless using effective contraception
- •Family history of sudden cardiac death
- •Prior history of cardiac disease that precludes the use of low dose digoxin
- •Medical or psychiatric condition that might affect participation in the study based on investigator judgement
- •Regular consumption of grapefruit or grapefruit juice
- •ECG abnormalities that preclude the use of low dose digoxin (intermittent complete heart block, second degree AV block, supraventricular arrhythmia associated with conducting pathways, ventricular tachycardia or fibrillation)
研究组 & 干预措施
Dolutegravir
Experimental
干预措施: Dolutegravir (Drug)
结局指标
主要结局
Change in pharmacokinetic parameter Cmin of dolutegravir
时间窗: Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment
Change in dolutegravir Cmin when dosed with standard, medium, high dose rifampicin
次要结局
- Number of participants with Grade 3 and above adverse events as assessed by DAIDS (corrected v2.1 July 2017)(From first dose of dolutegravir until study completion approximately 2 years)
- Change in pharmacokinetic parameter AUC of dolutegravir(Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment)
- Change in pharmacokinetic parameter Cmax of dolutegravir(Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment)
研究者
Helen Reynolds
Programme manager
University of Liverpool
研究点 (2)
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