DOR/ISL 100 mg/0.25 mg QD Open-Label Switch
- Conditions
- HIV-1 Infection
- Registration Number
- JPRN-jRCT2031220698
- Lead Sponsor
- Tanaka Yoshiyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 501
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method