Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)

April 1, 2024 updated by: Merck Sharp & Dohme LLC

A Phase 3 Open-label Rollover Clinical Study of Doravirine/Islatravir (DOR/ISL) Once-daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL Clinical Study

The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (DOR 100mg) and islatravir (ISL 0.75mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Holdsworth House Medical Practice ( Site 0700)
      • Sydney, New South Wales, Australia, 2010
        • St Vincent's Hospital-IBAC ( Site 0702)
    • Western Australia
      • Murdock, Western Australia, Australia, 6150
        • Fiona Stanley Hospital ( Site 0706)
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2R 0X7
        • Sheldon M. Chumir Health Centre-Southern Alberta Clinic ( Site 0106)
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • Vancouver Infectious Diseases Centre ( Site 0100)
    • Ontario
      • Hamilton, Ontario, Canada, L8S 1A4
        • Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 0109)
      • Toronto, Ontario, Canada, M5G 1K2
        • Maple Leaf Research ( Site 0105)
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital ( Site 0104)
    • Quebec
      • Montreal, Quebec, Canada, H2L 4E9
        • Clinique de médecine Urbaine du Quartier Latin ( Site 0110)
      • Montreal, Quebec, Canada, H2L 4P9
        • Clinique Medicale lActuel ( Site 0108)
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4781151
        • Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0202)
    • Region M. De Santiago
      • Santiago, Region M. De Santiago, Chile, 7500710
        • Biomedica Research Group-Infectology ( Site 0201)
      • Santiago, Region M. De Santiago, Chile, 8330034
        • Centro de Investigacion Clinicadela Universidad Catolica ( Site 0204)
      • Santiago, Region M. De Santiago, Chile, 8380420
        • Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0200)
  • Colombia
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760032
        • Fundacion Valle del Lili- CIC ( Site 0300)
  • France
      • Paris, France, 75018
        • Hôpital Bichat - Claude-Bernard-infectious diseases ( Site 1523)
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06202
        • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1504)
    • Bourgogne
      • Dijon, Bourgogne, France, 21000
        • Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1516)
    • Gironde
      • Bordeaux, Gironde, France, 33075
        • CHU de Bordeaux Hop St ANDRE-Médecine interne et maladies infectieuses ( Site 1512)
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31400
        • CHU de Toulouse-Infectious Disease-Tropical Diseases ( Site 1505)
    • Haute-Normandie
      • Rouen, Haute-Normandie, France, 76031
        • CHU Charles Nicolle-Inefectious disease ( Site 1506)
    • Herault
      • Montpellier, Herault, France, 34090
        • Hospital La Colombière ( Site 1518)
    • Ile-de-France
      • Bobigny, Ile-de-France, France, 93000
        • Hôpital Avicenne ( Site 1502)
      • Paris, Ile-de-France, France, 75010
        • Hôpital Saint-Louis-Infectious Diseases and tropical diseases ( Site 1511)
      • Paris, Ile-de-France, France, 75013
        • Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 1508)
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093 Cedex 1
        • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 1517)
    • Nord
      • Tourcoing, Nord, France, 59200
        • Tourcoing Hospital-Service Universitaire des Maladies Infectieuses et du Voyageur ( Site 1519)
    • Rhone
      • Lyon, Rhone, France, 69004
        • Hôpital de la Croix Rousse-Service des Maladies infectieuses et tropicales ( Site 1503)
  • Germany
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover-Department of Immunology and Rheumatology ( Site 1661)
  • Italy
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli-UOC Malattie Infettive ( Site 1606)
    • Lombardia
      • Milano, Lombardia, Italy, 20127
        • Ospedale San Raffaele-U.O. Malattie Infettive ( Site 1602)
      • Pavia, Lombardia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo-Dipartimento di Malattie Infettive: SC Malattie Infettive (
    • Milano
      • Milan, Milano, Italy, 20157
        • Ospedale Luigi Sacco-UOC Malattie Infettive I ( Site 1600)
  • Japan
      • Osaka, Japan, 540-0006
        • National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 09
      • Tokyo, Japan, 113-8677
        • Tokyo Metropolitan Komagome Hospital ( Site 0906)
    • Aichi
      • Nagoya, Aichi, Japan, 460-0001
        • National Hospital Organization Nagoya Medical Center ( Site 0903)
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital ( Site 0904)
      • Shinjyuku-ku, Tokyo, Japan, 162-8655
        • Center Hospital of the National Center for Global Health and Medicine ( Site 0901)
  • New Zealand
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • Christchurch Hospital-Infectious Diseases ( Site 0800)
  • Poland
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 50-136
        • Wrocl.Centr.Zdrowia SPZOZ Osr. Prof-Lecz Ch. Zak. i Terapii Uzaleznien ( Site 1703)
      • Wrocław, Dolnoslaskie, Poland, 50-220
        • EMC Instytut Medyczny S. A. Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1700)
    • Lodzkie
      • Ód, Lodzkie, Poland, 90-001
        • WSS im. W Bieganskiego O. Chorob Zakaznych i Hepatologii-F ( Site 1701)
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 01-201
        • Wojewódzki Szpital Zakaźny w Warszawie ( Site 1702)
  • Russian Federation
    • Kemerovskaya Oblast
      • Kemerovo, Kemerovskaya Oblast, Russian Federation, 650056
        • Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 2305)
    • Krasnoyarskiy Kray
      • Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation, 660049
        • Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2304)
    • Leningradskaya Oblast
      • Saint Petersburg, Leningradskaya Oblast, Russian Federation, 196645
        • Republican Clinical Infectious Hospital ( Site 2300)
    • Moskva
      • Moscow, Moskva, Russian Federation, 105275
        • Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2306)
      • Moscow, Moskva, Russian Federation, 105275
        • Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2302)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 190020
        • Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for Prophylact
    • Smolenskaya Oblast
      • Smolensk, Smolenskaya Oblast, Russian Federation, 214006
        • Smolensk Center for prevention and control of AIDS ( Site 2308)
    • Tatarstan, Respublika
      • Kazan, Tatarstan, Respublika, Russian Federation, 420140
        • Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2303)
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa, 9300
        • Josha Research ( Site 2403)
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Ezintsha ( Site 2404)
      • Pretoria, Gauteng, South Africa, 0083
        • Mediclinc Muelmed ( Site 2401)
    • Kwazulu-Natal
      • Durban, Kwazulu-Natal, South Africa, 4001
        • King Edward VIII Hospital ( Site 2410)
      • Durban, Kwazulu-Natal, South Africa, 4052
        • Wentworth Hospital ( Site 2400)
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • Desmond Tutu Health Foundation ( Site 2402)
  • Spain
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor ( Site 1906)
      • Madrid, Spain, 28040
        • Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 1902)
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz-Internal Medicine ( Site 1904)
    • Alicante
      • Elche, Alicante, Spain, 03202
        • Hospital General Universitario de Elche-Infectius Disease ( Site 1908)
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 1901)
    • Cataluna
      • Barcelona, Cataluna, Spain, 08036
        • HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 1900)
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28007
        • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 1903)
  • Switzerland
      • Berne, Switzerland, 3010
        • Inselspital Bern-Inselspital Infektiologie ( Site 2003)
    • Aargau
      • Basel, Aargau, Switzerland, 4031
        • University Hospital Basel-Infectiology ( Site 2002)
    • Geneve
      • Geneva, Geneve, Switzerland, 1211
        • Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2004)
    • Sankt Gallen
      • st.Gallen, Sankt Gallen, Switzerland, 9007
        • Cantonal Hospital St.Gallen ( Site 2001)
    • Ticino
      • Lugano, Ticino, Switzerland, 6903
        • Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 2005)
    • Zurich
      • Zürich, Zurich, Switzerland, 8091
        • UniversitätsSpital Zürich ( Site 2000)
  • United Kingdom
      • Manchester, United Kingdom, M8 5RB
        • North Manchester General Hospital ( Site 2105)
    • Brighton And Hove
      • East Sussex, Brighton And Hove, United Kingdom, BN2 5BE
        • Brighton and Sussex University Hospitals NHS Trust ( Site 2104)
    • Bristol, City Of
      • Bristol, Bristol, City Of, United Kingdom, BS10 5NB
        • Southmead Hospital ( Site 2103)
    • England
      • London, England, United Kingdom, NW32QG
        • Royal Free Hospital ( Site 2102)
      • London, England, United Kingdom, SE5 9RS
        • King's College Hospital ( Site 2101)
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Pueblo Family Physicians ( Site 0010)
    • California
      • Sacramento, California, United States, 95811
        • One Community Health ( Site 0045)
    • District of Columbia
      • Washington, District of Columbia, United States, 20005
        • Whitman-Walker Institute ( Site 0039)
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002
    • Florida
      • Fort Pierce, Florida, United States, 34982
        • Midway Immunology and Research Center ( Site 0033)
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center ( Site 0017)
      • Orlando, Florida, United States, 32806
        • Bliss Healthcare Services-Research ( Site 0030)
      • West Palm Beach, Florida, United States, 33407
        • Triple O Research Institute, P.A ( Site 0031)
    • Georgia
      • Savannah, Georgia, United States, 31401
        • Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 0015)
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Northstar Healthcare ( Site 0003)
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • KC CARE Health Center-Clinical Trials ( Site 0012)
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • ID Care ( Site 0028)
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 0006)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site
    • Texas
      • Bellaire, Texas, United States, 77401
        • St Hope Foundation ( Site 0041)
      • Dallas, Texas, United States, 75246
        • North Texas Infectious Diseases Consultants, P.A-Research ( Site 0004)
      • Fort Worth, Texas, United States, 76104
        • Texas Center for Infectious Disease Associates-Clinical Research ( Site 0026)
      • Houston, Texas, United States, 77098
        • The Crofoot Research Center ( Site 0008)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Is currently receiving DOR 100 mg/ISL 0.75 mg adult FDC tablet in an MSD-sponsored clinical study and has completed the last treatment visit.
  • Is considered by the investigator to have derived clinical benefit from receiving DOR/ISL and for whom further treatment with DOR/ISL is considered clinically appropriate.
  • Female is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); or is a non-pregnant WOCBP who agrees to the following during the intervention period and for at least 6 weeks after the last dose of study intervention: Not be sexually active, or if sexually active, to use an acceptable method of contraception; or is pregnant and continues to receive study intervention (where allowed by local regulations and as appropriate based on available data/local standard-of-care guidelines)

Exclusion Criteria:

  • Is taking or is anticipated to require any prohibited therapies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MK-8591A
Fixed dose combination (FDC) tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks.
Drug: MK-8591A
FDC tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants with serious adverse events (SAEs)
Time Frame: Up to Week 198
Percentage of participants with serious adverse events (SAEs)
Up to Week 198
Participants who discontinued due to an adverse event (AE)
Time Frame: Up to Week 192
Percentage of participants who discontinued study treatment due to an AE.
Up to Week 192

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

October 15, 2027

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8591A-033
  • MK-8591A-033 (Other Identifier: Merck)
  • jRCT2031210528 (Registry Identifier: jRCT)
  • 2020-001191-14 (EudraCT Number)
  • 2024-512215-53 (Other Identifier: EU CT)
  • U1111-1304-7926 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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