A Phase 3, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Antiretroviral Therapy

Tanaka Yoshiyuki0 个研究点目标入组 501 人开始时间: 2023年3月14日最近更新: 2023年11月20日

适应症

试验速览

暂无简介。

•Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL at screening
•-Has been receiving continuous, stable oral 2-drug or 3-drug combination (+- PK booster) ART with documented viral suppression (HIV-1 RNA <50 copies/mL) for >=3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen
•-Female is not a participant of childbearing potential (POCBP); or if a POCBP uses an acceptable contraceptive method or abstains from penile-vaginal intercourse as their preferred and usual lifestyle; has a negative highly sensitive pregnancy test; and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator

•-Has HIV-2 infection
•-Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
•-Has a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening
•-Has active hepatitis B virus (HBV) infection
•-Has chronic hepatitis C virus (HCV) infection consistent with cirrhosis
•-Has a <=5 years prior history of malignancy
•-Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A) inducers
•-Has taken long-acting HIV therapy at any time
•-Is currently participating in or has participated in a clinical study and received (or is receiving) an investigational compound or device from 45 days prior to Day 1 through the study treatment period
•-Has a documented or known virologic resistance to DOR

发起方

Tanaka Yoshiyuki