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NCT04233879

PHASE3

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 3 Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir Once-Daily in HIV-1 Infected Treatment-Naïve Participants

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

599

Start Date

2020-02-28

Completion Date

2025-01-29

Last Updated

2026-06-03

Healthy Volunteers

Conditions

HIV-1 Infection

Interventions

DRUG

DOR/ISL

100 mg DOR/0.75 mg ISL FDC single tablet taken once daily by mouth.

DRUG

BIC/FTC/TAF

BIC/FTC/TAF 50/200/25 mg FDC single tablet taken once daily by mouth.

DRUG

Placebo to BIC/FTC/TAF

Placebo single tablet matched to BIC/FTC/TAF taken by mouth.

DRUG

Placebo to DOR/ISL

Placebo single tablet matched to DOR/ISL taken by mouth.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (95)

University of Alabama at Birmingham 1917 Research Clinic ( Site 5610)

Birmingham, Alabama, United States

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

McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 5702)

Montreal, Quebec, Canada

Hospital Dr. Hernan Henriquez Aravena ( Site 5905)

Temuco, Araucania, Chile

Clinica Universidad Catolica del Maule ( Site 5909)

Talca, Maule Region, Chile

Clinica Arauco Salud ( Site 5900)

Santiago, Region M. de Santiago, Chile

Hospital Clinico de la Universidad Catolica ( Site 5903)

Santiago, Region M. de Santiago, Chile

Fundacion Arriaran ( Site 5901)

Santiago, Region M. de Santiago, Chile

Centro Cardiovascular Cardiosur ( Site 5907)

Santiago, Region M. de Santiago, Chile

Hospital Universitario San Ignacio ( Site 6005)

Bogotá, Bogota D.C., Colombia

Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 6006)

Bogotá, Bogota D.C., Colombia

Fundacion Valle del Lili ( Site 6001)

Cali, Valle del Cauca Department, Colombia

A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 6124)

Paris, Ain, France

Hopital de la Croix-Rousse ( Site 6127)

Lyon, Auvergne-Rhône-Alpes, France

Centre Hospitalier Regional du Orleans ( Site 6108)

Orléans, Centre-Val de Loire, France

Hopital Francois Mitterrand ( Site 6119)

Dijon, Cote-d Or, France

CHU de Bordeaux. Hopital Pellegrin ( Site 6116)

Bordeaux, Gironde, France

Centre Hospitalier de Tourcoing ( Site 6100)

Tourcoing, Nord, France

Hopital Avicenne ( Site 6102)

Bobigny, Seine-Saint-Denis, France

A.P.H. Paris, Hopital Saint Louis ( Site 6114)

Paris, France

Hopital Saint-Antoine ( Site 6113)

Paris, France

Hopital Pitie Salpetriere ( Site 6111)

Paris, France

Universitaetsklinik Freiburg ( Site 6206)

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Klinikum der LMU München ( Site 6204)

Munich, Bavaria, Germany

MVZ Munchen am Goetheplatz ( Site 6202)

Munich, Bavaria, Germany

Infektiologikum ( Site 6201)

Frankfurt am Main, Hesse, Germany

Universitaetsklinikum Bonn ( Site 6200)

Bonn, North Rhine-Westphalia, Germany

EPIMED- Ges. f. epidemiolog. u. klin. Forschung in der Medizin mbH ( Site 6208)

Berlin, Germany

Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 6210)

Hamburg, Germany

Rambam Medical Center ( Site 6701)

Haifa, Israel

Hadassah Ein Kerem Medical Center ( Site 6702)

Jerusalem, Israel

Chaim Sheba Medical Center. ( Site 6704)

Ramat Gan, Israel

Kaplan Medical Center ( Site 6700)

Rehovot, Israel

Sourasky Medical Center ( Site 6705)

Tel Aviv, Israel

A.O.R.N. dei Colli - Ospedale Cotugno ( Site 6407)

Naples, Campania, Italy

Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 6404)

Modena, Emilia-Romagna, Italy

ASST Papa Giovanni XXIII ( Site 6411)

Bergamo, Lombardy, Italy

Ospedale San Gerardo ASST Monza ( Site 6412)

Monza, Monza E Brianza, Italy

Ospedale Amedeo di Savoia ( Site 6414)

Turin, Piedmont, Italy

Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 6401)

Milan, Italy

Salute San Raffaele ( Site 6402)

Milan, Italy

Azienda Ospedaliera San Paolo ( Site 6403)

Milan, Italy

ASST Fatebenefratelli-Ospedale Sacco ( Site 6400)

Milan, Italy

IRCCS Policlinico San Matteo ( Site 6410)

Pavia, Italy

Azienda USL di Pescara-Presidio Ospedaliero di Pescara ( Site 6413)

Pescara, Italy

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 6405)

Roma, Italy

National Hospital Organization Nagoya Medical Center ( Site 6903)

Nagoya, Aichi-ken, Japan

Kumamoto University Hospital ( Site 6905)

Kumamoto, Japan

National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 69

Osaka, Japan

Tokyo Medical University Hospital ( Site 6904)

Tokyo, Japan

Center Hospital of the National Center for Global Health and Medicine ( Site 6901)

Tokyo, Japan

JOSHA Research ( Site 6605)

Bloemfontein, Free State, South Africa

Chris Hani Baragwanath Hospital - ICU ( Site 6608)

Johannesburg, Gauteng, South Africa

Wits Health Consortium. Clinical HIV Research Unit ( Site 6614)

Johannesburg, Gauteng, South Africa

Ezintsha ( Site 6609)

Johannesburg, Gauteng, South Africa

Wentworth Hospital ( Site 6607)

Durban, KwaZulu-Natal, South Africa

Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6617)

Cape Town, Western Cape, South Africa

Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 6613)

Cape Town, Western Cape, South Africa

Be Part Yoluntu Centre ( Site 6603)

Mbekweni, Paarl, Western Cape, South Africa

Hospital General de Elche ( Site 6308)

Elche, Alicante, Spain

Hospital Universitari Germans Trias i Pujol ( Site 6301)

Badalona, Barcelona, Spain

Hospital Universitari de Bellvitge ( Site 6312)

LHospitalet de Llobregat, Barcelona, Spain

Hospital Vall D Hebron ( Site 6302)

Barcelona, Catalonia, Spain

Hospital Clinic i Provincial ( Site 6300)

Barcelona, Catalonia, Spain

Hospital General Universitario Gregorio Maranon ( Site 6303)

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz ( Site 6307)

Madrid, Spain

Hospital Universitario 12 de Octubre ( Site 6305)

Madrid, Spain

Hospital Universitario La Paz ( Site 6304)

Madrid, Spain

Hospital Universitario Virgen de la Victoria ( Site 6309)

Málaga, Spain

Kaohsiung Veterans General Hospital ( Site 7102)

Kaohsiung City, Taiwan

National Cheng Kung University Hospital ( Site 7101)

Tainan, Taiwan

National Taiwan University Hospital ( Site 7100)

Taipei, Taiwan

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (95)