DOR/ISL 100 mg/0.25 mg QD Blinded Switch
- Conditions
- HIV-1 Infection
- Registration Number
- JPRN-jRCT2051230003
- Lead Sponsor
- Tanaka Yoshiyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 501
Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL
- Has been receiving BIC/FTC/TAF therapy 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 participant of childbearing potential, not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration
- Has HIV-2 infection
- 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 with laboratory values consistent with cirrhosis
- Has a history of malignancy <=5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A) inducers
- Has a documented or known virologic resistance to DOR
- Has taken long-acting HIV therapy at any time (e.g., cabotegravir, lenacapavir)
- 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 except those currently enrolled in the comparator arm of an ongoing DOR/ISL study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method