A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)
- Conditions
- HIV-1 Infection
- Registration Number
- NCT05631093
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL at screening<br><br> - Has been receiving continuous, stable oral 2-drug or 3-drug combination (± PK<br> booster) ART with documented viral suppression (HIV-1 RNA <50 copies/mL) for =3<br> consecutive months prior to providing documented informed consent and has no history<br> of prior virologic treatment failure on any past or current regimen<br><br> - Female is not a participant of childbearing potential (POCBP); or if a POCBP uses an<br> acceptable contraceptive method or abstains from penile-vaginal intercourse as their<br> preferred and usual lifestyle; has a negative highly sensitive pregnancy test; and<br> whose medical history, menstrual history, and recent sexual activity has been<br> reviewed by the investigator<br><br>Exclusion Criteria:<br><br> - Has HIV-2 infection<br><br> - Has hypersensitivity or other contraindication to any of the components of the study<br> interventions as determined by the investigator<br><br> - Has a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining<br> opportunistic infection within 30 days prior to screening<br><br> - Has active hepatitis B virus (HBV) infection<br><br> - Has chronic hepatitis C virus (HCV) infection consistent with cirrhosis<br><br> - Has a =5 years prior history of malignancy<br><br> - Is taking or is anticipated to require systemic immunosuppressive therapy, immune<br> modulators, or strong and moderate cytochrome P450 3A (CYP3A ) inducers<br><br> - Has taken long-acting HIV therapy at any time<br><br> - Is currently participating in or has participated in a clinical study and received<br> (or is receiving) an investigational compound or device from 45 days prior to Day 1<br> through the study treatment period<br><br> - Has a documented or known virologic resistance to DOR
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Participants with HIV-1 RNA =50 copies/mL at Week 48;Participants with one or more AEs at Week 48;Participants with an AE leading to discontinuation of study intervention at Week 48
- Secondary Outcome Measures
Name Time Method