The influence of having bariatric surgery on the pharmacokinetics, safety and efficacy of the novel non-nucleoside reverse transcriptase inhibitor doravirine (LABRADOR) - LABRADOR

Radboud University Medical Center0 个研究点目标入组 8 人开始时间: 2022年2月16日最近更新: 2024年2月19日

适应症

试验速览

暂无简介。

•-HIV-infected
•-VL suppressed <40c/ml for at least 6 months, blips are allowed
•-planned to have BS (GBP or SG)
•-Able to sign informed consent
•-Age > or equal to 18 years
•-Using DOR for at least 4 weeks prior to BS with VL < 40 copies/mL prior to the surgery
•7.Using doravirine for at least 4 weeks prior to bariatric surgery with no detectable viral load
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 6
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•-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 DOR
•-Has significant hypersensitivity or other contraindication to DOR
•-Creatinine clearance <40 ml/min
•-Severe liver dysfunction (Diagnosed liver cirrhosis: Child-Pugh C)
•-Pregnancy or planning to be pregnant during first 6 months post BS.

发起方