Efficacy and safety of early switching to dolutegravir/lamivudine (DTG/3TC) from INSTI-based three-drug regimens in HIV-1-infected adults previously naïve who achieve virological suppression - Early DOlutegravir/LAmivudine Switching after virological suppression (EDOLAS Study)

SOCIETA' ITALIANA MALATTIE INFETTIVE E TROPICALI0 个研究点目标入组 440 人开始时间: 2021年5月24日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•HIV-1 documented infection
•Age >=18 years
•To be treated as ART naïve for overall less than 18 months before screening
•To receive a stable (not changed) INSTI-based first-line three-drug ART (see Target Population section for regimens allowed); switch between different NRTIs are allowed
•To have reached a HIV-1 RNA <50 copies/mL during INSTI first-line therapy for less than 12 months. At least a single HIV-1 RNA determination below the threshold within the 6 months before enrollment is required (if a following determination in present, this should not be >=50 copies (cp)/mL)
•No known allergy or intolerance to NRTIs, or INSTIs
•Being able to comply with the protocol requirements
•Informed consent signed
•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 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 140

•Having failed virologically
•Having changed the INSTI drug
•Any major INSTI- or NRTI-resistance-associated mutation documented before starting ART
•Pregnancy or breast-feeding
•HBsAg positivity
•HCV-RNA positivity needing for any hepatitis C virus (HCV) therapy during the study
•An active malignancy or opportunistic infection requiring active treatment or primary prophylaxis
•Women of childbearing potential not adopting an effective birth control system throughout the study period
•Creatinine clearance of <50 mL/min/1.73m2 via CKD-EPI method
•A life expectancy <2 years
•Use of HIV immunotherapeutic vaccines; other experimental agents, ART drugs not otherwise specified in the protocol, cytotoxic chemotherapy, systemically administered immunomodulators
•Individuals who in the investigator’s judgment, poses a significant suicidality risk;
•Major Depression, Bipolar Disorders and Psychoses

发起方

SOCIETA' ITALIANA MALATTIE INFETTIVE E TROPICALI