nderstanding the Impact of HIV-DNA resistance mutations detected by NGS in Simplificationstrategies to 2-Drug Regimens for patients virologically suppressed with previous failures and/orprevious resistance mutations: a prospective multi-centre intervention study (INS-2DR) - INS-2DR

ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE LAZZARO SPALLANZANI0 个研究点目标入组 210 人开始时间: 2021年6月7日最近更新: 2022年3月14日

适应症

试验速览

暂无简介。

•i) HIV-1 infection;
•ii) age >= 18 years;
•iii) history of previous virological failures and/or previous resistance mutations to NRTI or NNRTI;
•iv) HIV-RNA< 50 copies/ml for <=3 years, with last determination in the previous 2 months;
•v) on any ART apart from DTG + NRTI or DTG+NNRTI;
•vi) written informed consent.
•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 180
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•i) multiple class drug resistance or known dolutegravir resistance;
•ii) HBsAg positivity;
•iii) women of childbearing potential not adopting an effective birth control system throughout the study period
•iv) pregnancy
•v) relevant psychiatric disease
•vi) creatinine clearance of <50 mL/min/1.73m2

发起方

ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE LAZZARO SPALLANZANI