A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)
- Conditions
- HIV-1 Infection
- Registration Number
- NCT05630755
- 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
The key inclusion and exclusion criteria include but are not limited to the following:<br><br>Inclusion Criteria:<br><br> - Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL<br><br> - Has been receiving BIC/FTC/TAF therapy with documented viral suppression (HIV-1 RNA<br> <50 copies/mL) for =3 consecutive months prior to providing documented informed<br> consent and has no history of prior virologic treatment failure on any past or<br> current regimen<br><br> - Female is not a participant of childbearing potential (POCBP); or if a participant<br> of childbearing potential, not pregnant or breastfeeding, and is willing to use an<br> acceptable contraceptive method or abstain from heterosexual intercourse for study<br> duration<br><br>Exclusion Criteria:<br><br> - Has HIV-2 infection<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 with laboratory values consistent with<br> cirrhosis<br><br> - Has a history of malignancy =5 years prior to providing documented informed consent<br> except for adequately treated basal cell or squamous cell skin cancer, in situ<br> cervical cancer, or cutaneous Kaposi's sarcoma<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 a documented or known virologic resistance to DOR<br><br> - Has taken long-acting HIV therapy at any time (e.g., cabotegravir, lenacapavir)<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 except those currently enrolled in the comparator<br> arm of an ongoing DOR/ISL study
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants with HIV-1 RNA =50 copies/mL at Week 48;Percentage of participants who experience adverse events (AEs) through Week 48;Percentage of participants who discontinue study intervention due to AEs through Week 48
- Secondary Outcome Measures
Name Time Method