DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: HIV-1 Infection

In brief

This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL \[MK-8591A\]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.

Key facts

Study ID

NCT05705349

Run by

Merck Sharp & Dohme LLC

People needed

537

Starts

2023-03-08

Expected to finish

2029-08-05

Last updated by the study team

2025-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Is HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL at screening
• Is naïve to antiretroviral therapy (ART) defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection
• If female, is not a participant of childbearing potential (POCBP); or if a POCBP, is not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration

You may not qualify if…

• Has HIV-2 infection
• Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
• Has a diagnosis of an active AIDS-defining opportunistic infection within 30 days prior to screening
• Has active hepatitis B infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA]-positive).
• Has chronic hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid [RNA]) and lab values are 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
• 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, such that it is not in the best interest of the participant to participate

Where it is running

• Pacific Oaks Medical Group ( Site 5681) — Beverly Hills, California, United States
• Ruane Clinical Research Group, Inc ( Site 5658) — Los Angeles, California, United States
• Vivent Health ( Site 5694) — Denver, Colorado, United States
• Washington Health Institute ( Site 5689) — Washington D.C., District of Columbia, United States
• Midway Immunology and Research Center ( Site 5657) — Ft. Pierce, Florida, United States
• AHF The Kinder Medical Group ( Site 5672) — Miami, Florida, United States
• AHF South Beach ( Site 5663) — Miami Beach, Florida, United States
• Orlando Immunology Center ( Site 5654) — Orlando, Florida, United States
• CAN Community Health - Sarasota ( Site 5668) — Sarasota, Florida, United States
• Triple O Research Institute, P.A ( Site 5666) — West Palm Beach, Florida, United States
• Emory University and Grady Health System-Medicine ( Site 5690) — Atlanta, Georgia, United States
• Emory University Hospital Midtown Infectious Disease Clinic ( Site 5673) — Atlanta, Georgia, United States
• Atlanta I.D. Group ( Site 5680) — Atlanta, Georgia, United States
• Metro Infectious Diseases Consultants L.L.C. ( Site 5653) — Decatur, Georgia, United States
• Mercer University, Department of Internal Medicine ( Site 5655) — Macon, Georgia, United States
• Rush University Medical Center-Infectious Disease ( Site 5671) — Chicago, Illinois, United States
• University of Illinois at Chicago-Project WISH ( Site 5685) — Chicago, Illinois, United States
• Howard Brown Health Center-Clinical Research ( Site 5665) — Chicago, Illinois, United States
• Be Well Medical Center ( Site 5650) — Berkley, Michigan, United States
• Henry Ford Hospital ( Site 5667) — Detroit, Michigan, United States
• KC CARE Health Center-Clinical Trials ( Site 5670) — Kansas City, Missouri, United States
• Jubilee Clinical Research ( Site 5679) — Las Vegas, Nevada, United States
• Las Vegas Research Center ( Site 5691) — Las Vegas, Nevada, United States
• ID Care ( Site 5676) — Hillsborough, New Jersey, United States
• Pueblo Family Physicians ( Site 5674) — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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