Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)

Completed · Phase 3 · Has a placebo group

Conditions studied: HIV Infection

In brief

This study will evaluate the safety and efficacy of a switch to Doravirine/Islatravir (DOR/ISL) (MK-8591A) (a fixed dose combination of doravirine 100 mg and islatravir 0.75 mg) in participants living with human immunodeficiency virus-1 (HIV-1) virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to DOR/ISL (MK-8591A) will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Participants who benefit from their assigned intervention (as determined by investigator) will be able to continue treatment through a 24-week study extension.

Key facts

Study ID

NCT04223791

Run by

Merck Sharp & Dohme LLC

People needed

643

Starts

2020-02-18

Expected to finish

2025-02-27

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is HIV-1 positive with plasma Human Immunodeficiency Virus 1 (HIV-1) RNA <50 copies/mL at screening.
• Has been receiving bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) therapy with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen.
• Females are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.

You may not qualify if…

• Has HIV-2 infection.
• Has an active diagnosis of hepatitis due to any cause, including active Hepatitis B Virus (HBV) co-infection.
• Has a history of malignancy ≤5 years prior to signing 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 any prohibited therapies.
• Is currently participating in or has participated in a clinical study with 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 doravirine (DOR).
• expects to conceive or donate eggs at any time during the study.

Where it is running

• Pacific Oaks Medical Group ( Site 2765) — Beverly Hills, California, United States
• Men's Health Foundation ( Site 2749) — Los Angeles, California, United States
• Kaiser Permanente Los Angeles Medical Center ( Site 2775) — Los Angeles, California, United States
• Eisenhower Medical Center ( Site 2744) — Palm Springs, California, United States
• University of California, Davis, Division of ID Research ( Site 2702) — Sacramento, California, United States
• Zuckerberg San Francisco General Hospital UCSF ( Site 2743) — San Francisco, California, United States
• Whitman-Walker Clinic ( Site 2728) — Washington D.C., District of Columbia, United States
• TheraFirst Medical Center ( Site 2742) — Fort Lauderdale, Florida, United States
• Midway Immunology and Research ( Site 2759) — Ft. Pierce, Florida, United States
• The Kinder Medical Group ( Site 2739) — Miami, Florida, United States
• AHF South Beach ( Site 2780) — Miami Beach, Florida, United States
• Orlando Immunology Center ( Site 2734) — Orlando, Florida, United States
• Triple O Research Institute, P.A. ( Site 2755) — West Palm Beach, Florida, United States
• Augusta University ( Site 2752) — Augusta, Georgia, United States
• Infectious Disease Specialists Of Atlanta PC ( Site 2719) — Decatur, Georgia, United States
• Mercer University ( Site 2738) — Macon, Georgia, United States
• Chatham County Health Department ( Site 2731) — Savannah, Georgia, United States
• Hennepin County Medical Center ( Site 2733) — Minneapolis, Minnesota, United States
• Kansas City CARE Clinic ( Site 2718) — Kansas City, Missouri, United States
• ID Care ( Site 2751) — Hillsborough, New Jersey, United States
• Icahn School of Medicine at Mount Sinai ( Site 2700) — New York, New York, United States
• Montefiore Einstein Center ( Site 2730) — The Bronx, New York, United States
• North Texas ID Consultants, PA ( Site 2707) — Dallas, Texas, United States
• The Crofoot Research Center, Inc. ( Site 2715) — Houston, Texas, United States
• Pueblo Family Physicians ( Site 2717) — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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