Efficacy and safety of the switch from Efavirenz / emtricitabine / tenofovir difumarate taken once daily or alternate days to Bictegravir / emtricitabine / tenofovir alafenamide in HIV + virologically suppressed patients - EBONY

ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE LAZZARO SPALLANZANI0 个研究点目标入组 240 人开始时间: 2021年6月8日最近更新: 2021年9月7日

适应症

试验速览

暂无简介。

•- Age > 18 years
•- Stable treatment with EFV/TDF/FTC either QD or ATAD for at least 24 weeks before the screening
•-Virological suppression (HVRNA < 50 cp/mL) for at least 24 weeks before the screening.
•-Historical Genotyping Resistance Test (GRT) without known resistance mutations to any antiretroviral drug class
•- No previous virological failures on INI-based regimens
•- eGFR>50 ml/min
•- Women of childbearing potential must accept the use of one of the following contraceptive methods, from the screening for the duration of the study: Combined hormonal contraceptives associated with ovulation inhibitors (oral, intravaginal, transdermal); progestagogenic hormonal contraceptives associated with an ovulation inhibitor (oral, injectable, implantable); intrauterine devices
•d; intrauterine devices with hormonal release system; bilateral tubal ligation; partner's vasectomy; sexual abstinence (hetero).
•-Men must agree to specified highly effective method of contraception during heterosexual intercourse or practice sexual abstinence from first dose throughout the study period
•- 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 220
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•- Women who are pregnant or breastfeeding
•-HCV co-infection
•-Severe hepatic impairment
•-Known hypersensitivity to the study drug, the metabolites or formulation excipients
•-Presence of an opportunistic infection or an AIDS-defining illness, unless they are directly attributable to the acute seroconversion illness
•-Ongoing malignancy (including untreated carcinoma in-situ) other than basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
•-Active, serious infections (other than HIV 1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior the screening.
•-Receipt of immunosuppressive medications or immune-modulators within the past 6 months.
•-Use of pshycoactive substances which can interfere with patients adherence to the prescribed regimen
•-Subjects who do not guarantee an appropriate adherence to the study procedures, according to the investigator’s opinion
•-Enrollement in other clinical trials or pharmacological treatment with sperimental drug within the past 30 days.
•-Inability to express informed consent

发起方

ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE LAZZARO SPALLANZANI