Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)

Completed · Phase 3 · Has a placebo group

Conditions studied: HIV-1 Infection

In brief

This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL \[also known as MK-8591A\]) in treatment-naïve participants living with human immunodeficiency virus type-1 (HIV-1) infection. The primary objectives are to evaluate the antiretroviral activity, safety, and tolerability of DOR/ISL compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that DOR/ISL is noninferior or superior to BIC/FTC/TAF treatment based on the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.

Key facts

Study ID

NCT04233879

Run by

Merck Sharp & Dohme LLC

People needed

599

Starts

2020-02-28

Expected to finish

2025-01-29

Last updated by the study team

2026-06-03

Who can join

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

You may qualify if…

• Is human immunodeficiency virus type 1 (HIV-1) positive
• Is naïve to antiretroviral therapy (ART) defined as having received ≤10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection including prevention of mother-to-child transmission up to 1 month prior to screening.
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); 2) Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis); 3) 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; 4) If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required

You may not qualify if…

• Has human immunodeficiency virus type 2 (HIV-2) infection
• Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
• Has an active diagnosis of hepatitis due to any cause, including active hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen [HBsAg]-positive or hepatitis B virus deoxyribonucleic acid [HBV DNA]-positive)
• 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
• Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study
• Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1
• Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapy from 45 days prior to Day 1 through the study intervention period
• 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 intervention period
• Has a documented or known virologic resistance to any approved HIV-1 reverse transcriptase inhibitor, or any study intervention
• Has exclusionary laboratory values within 45 days prior to Day 1
• Is female and is expecting to conceive or donate eggs at any time during the study

Where it is running

• Pueblo Family Physicians ( Site 5606) — Phoenix, Arizona, United States
• Ruane Clinical Research Group, Inc. ( Site 5624) — Los Angeles, California, United States
• Midway Immunology and Research ( Site 5622) — Ft. Pierce, Florida, United States
• The Kinder Medical Group ( Site 5615) — Miami, Florida, United States
• Floridian Clinical Research, LLC ( Site 5625) — Miami Lakes, Florida, United States
• Orlando Immunology Center ( Site 5613) — Orlando, Florida, United States
• CAN Community Health ( Site 5627) — Sarasota, Florida, United States
• Triple O Research Institute, P.A. ( Site 5621) — West Palm Beach, Florida, United States
• Columbus Regional Research Institute ( Site 5616) — Columbus, Georgia, United States
• Infectious Disease Specialists Of Atlanta PC ( Site 5608) — Decatur, Georgia, United States
• Hennepin Healthcare-Hennepin Healthcare-ID ( Site 5633) — Minneapolis, Minnesota, United States
• Kansas City CARE Clinic ( Site 5607) — Kansas City, Missouri, United States
• University of Pennsylvania ( Site 5630) — Philadelphia, Pennsylvania, United States
• Saint Hope Foundation, Inc. ( Site 5629) — Bellaire, Texas, United States
• North Texas ID Consultants, PA ( Site 5604) — Dallas, Texas, United States
• Texas Centers for Infectious Disease Associates P.A. ( Site 5619) — Fort Worth, Texas, United States
• Helios Salud S.A. ( Site 5802) — Buenos Aires, Buenos Aires F.D., Argentina
• IDEAA Foundation ( Site 5807) — Buenos Aires, Buenos Aires F.D., Argentina
• Fundación Huesped ( Site 5801) — C.a.b.a, Buenos Aires F.D., Argentina
• Instituto CAICI ( Site 5803) — Rosario, Santa Fe Province, Argentina
• Instituto Oulton ( Site 5804) — Córdoba, Argentina
• Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 5703) — Hamilton, Ontario, Canada
• Toronto General Hospital - University Health Network ( Site 5705) — Toronto, Ontario, Canada
• Clinique Medicale L Actuel ( Site 5714) — Montreal, Quebec, Canada
• University of Alabama at Birmingham 1917 Research Clinic ( Site 5610) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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