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

RECRUITING

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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.

Conditions:

🦠 HIV-1 Infection

🗓️ Study Start (Actual) 8 March 2023

🗓️ Primary Completion (Estimated) 19 October 2025

✅ Study Completion (Estimated) 1 November 2026

👥 Enrollment (Estimated) 500

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE3

Locations:

📍 Phoenix, Arizona, United States

📍 Beverly Hills, California, United States

📍 Los Angeles, California, United States

📍 Washington, District of Columbia, United States

📍 Fort Pierce, Florida, United States

📍 Miami Beach, Florida, United States

📍 Miami, Florida, United States

📍 Orlando, Florida, United States

📍 Sarasota, Florida, United States

📍 West Palm Beach, Florida, United States

📍 Atlanta, Georgia, United States

📍 Decatur, Georgia, United States

📍 Macon, Georgia, United States

📍 Chicago, Illinois, United States

📍 Berkley, Michigan, United States

📍 Detroit, Michigan, United States

📍 Kansas City, Missouri, United States

📍 Las Vegas, Nevada, United States

📍 Hillsborough, New Jersey, United States

📍 Newark, New Jersey, United States

📍 Bronx, New York, United States

📍 New York, New York, United States

📍 Charlotte, North Carolina, United States

📍 Greensboro, North Carolina, United States

📍 Cincinnati, Ohio, United States

📍 Austin, Texas, United States

📍 Bellaire, Texas, United States

📍 Dallas, Texas, United States

📍 El Paso, Texas, United States

📍 Fort Worth, Texas, United States

📍 Longview, Texas, United States

📍 Caba, Buenos Aires, Argentina

📍 Mar del Plata, Buenos Aires, Argentina

📍 Rosario, Santa Fe, Argentina

📍 Buenos Aires, Argentina

📍 Cordoba, Argentina

📍 Hamilton, Ontario, Canada

📍 Toronto, Ontario, Canada

📍 Montréal, Quebec, Canada

📍 Temuco, Araucania, Chile

📍 Talca, Maule, Chile

📍 Santiago, Region M. De Santiago, Chile

📍 Barranquilla, Atlantico, Colombia

📍 Bogota, Distrito Capital De Bogota, Colombia

📍 Cali, Valle Del Cauca, Colombia

📍 Santo Domingo De Guzman, Santo Domingo, Dominican Republic

📍 Nice, Alpes-Maritimes, France

📍 Bobigny, Ile-de-France, France

📍 Paris, Ile-de-France, France

📍 Tourcoing, Nord, France

📍 Paris, France

📍 Freiburg, Baden-Wurttemberg, Germany

📍 München, Bayern, Germany

📍 Bonn, Nordrhein-Westfalen, Germany

📍 Hamburg, Germany

📍 Guatemala, Guatemala

📍 Haifa, Israel

📍 Jerusalem, Israel

📍 Ramat Gan, Israel

📍 Tel Aviv, Israel

📍 Nagoya, Aichi, Japan

📍 Shinjuku-ku, Tokyo, Japan

📍 Shinjyuku-ku, Tokyo, Japan

📍 Osaka, Japan

📍 Alor Setar, Kedah, Malaysia

📍 Lembah Pantai, Kuala Lumpur, Malaysia

📍 George Town, Pulau Pinang, Malaysia

📍 Kuching, Sarawak, Malaysia

📍 Batu Caves, Selangor, Malaysia

📍 Sungai Buloh, Selangor, Malaysia

📍 Kuala Lumpur, Malaysia

📍 Mexico City, Distrito Federal, Mexico

📍 Ponce, Puerto Rico

📍 San Juan, Puerto Rico

📍 Bloemfontein, Free State, South Africa

📍 Johannesburg, Gauteng, South Africa

📍 Durban, Kwazulu-Natal, South Africa

📍 Ladysmith, Kwazulu-Natal, South Africa

📍 Pietermaritzburg, Kwazulu-Natal, South Africa

📍 Brits, North-West, South Africa

📍 Cape Town, Western Cape, South Africa

📍 Paarl, Western Cape, South Africa

📍 Elche, Alicante, Spain

📍 Badalona, Barcelona, Spain

📍 Barcelona, Cataluna, Spain

📍 L'Hospitalet De Llobregat,Barcelona, Cataluna, Spain

📍 Madrid, Madrid, Comunidad De, Spain

📍 Barcelona, Spain

📍 Madrid, Spain

📍 Malaga, Spain

📍 Basel, Basel-Stadt, Switzerland

📍 Genève, Geneve, Switzerland

📍 Bangkok, Krung Thep Maha Nakhon, Thailand

📍 Chiang Mai, Thailand

📍 Altindağ, Ankara, Turkey

📍 Ankara, Turkey

📍 Bristol, Bristol, City Of, United Kingdom

📍 London, England, United Kingdom

📍 Manchester, England, United Kingdom

📍 London, London, City Of, United Kingdom

More locations available...

📋 Eligibility Criteria

Description

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 20 January 2023
First Submitted that Met QC Criteria 20 January 2023
First Posted 30 January 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 22 July 2024
Last Update Posted 23 July 2024
Last Verified July 2024