A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)

January 3, 2024 updated by: Merck Sharp & Dohme LLC

A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) QD in a Phase 3 Clinical Study

The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

650

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 Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1141ACG
        • Helios Salud ( Site 1002)
      • Buenos Aires, Argentina, C1202ABB
        • Fundación Huésped ( Site 1001)
      • Buenos Aires, Argentina, C1405CKC
        • Fundación IDEAA ( Site 1005)
    • Cordoba
      • Córdoba, Cordoba, Argentina, X5000JJS
        • Instituto Oulton ( Site 1004)
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000PBJ
        • Instituto CAICI SRL ( Site 1003)
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Holdsworth House Medical Practice ( Site 1100)
      • Sydney, New South Wales, Australia, 2010
        • St Vincent's Hospital-IBAC ( Site 1103)
    • Queensland
      • Brisbane, Queensland, Australia, 4006
        • Holdsworth House Medical Practice - Brisbane ( Site 1101)
    • Victoria
      • Melbourne, Victoria, Australia, 3181
        • Prahran Market Clinic ( Site 1102)
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 1A4
        • Hamilton Health Sciences- Urgent Care Centre ( Site 1304)
      • Toronto, Ontario, Canada, M5G 1K2
        • Maple Leaf Research ( Site 1301)
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital ( Site 1300)
    • Quebec
      • Montreal, Quebec, Canada, H2L 4E9
        • Clinique de médecine Urbaine du Quartier Latin ( Site 1305)
      • Montréal, Quebec, Canada, H2L 4P9
        • Clinique Medicale lActuel ( Site 1303)
      • Montréal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre ( Site 1306)
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4781151
        • Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 1403)
    • Maule
      • Talca, Maule, Chile, 3460000
        • Clinica Universidad Catolica del Maule ( Site 1405)
    • Region M. De Santiago
      • Santiago, Region M. De Santiago, Chile, 7500710
        • Biomedica Research Group-Infectology ( Site 1401)
      • Santiago, Region M. De Santiago, Chile, 8330034
        • Pontificia Universidad Catolica de Chile ( Site 1407)
      • Santiago, Region M. De Santiago, Chile, 8380420
        • Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 1400)
      • Santiago, Region M. De Santiago, Chile, 8910259
        • Cardio Sur ( Site 1409)
  • Colombia
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 111321
        • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 1502)
      • Bogotá, Distrito Capital De Bogota, Colombia, 110231
        • Hospital Universitario San Ignacio-Infectious ( Site 1501)
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760032
        • Fundación Valle del Lili ( Site 1500)
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 1901)
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center-Infecious Disease ( Site 1902)
      • Ramat Gan, Israel, 5262100
        • Sheba Medical Center-HIV unit ( Site 1903)
      • Tel Aviv, Israel, 64239
        • Sourasky Medical Center ( Site 1904)
  • Japan
      • Osaka, Japan, 540-0006
        • National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 21
    • Aichi
      • Nagoya, Aichi, Japan, 460-0001
        • National Hospital Organization Nagoya Medical Center ( Site 2103)
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8677
        • Tokyo Metropolitan Komagome Hospital ( Site 2105)
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital ( Site 2104)
      • Shinjyuku-ku, Tokyo, Japan, 162-8655
        • Center Hospital of the National Center for Global Health and Medicine ( Site 2101)
  • New Zealand
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • Christchurch Hospital-Infectious Diseases ( Site 2200)
  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Clinical Research Puerto Rico ( Site 2400)
      • San Juan, Puerto Rico, 00909
        • HOPE Clinical Research ( Site 2401)
  • Russian Federation
    • Kemerovskaya Oblast
      • Kemerovo, Kemerovskaya Oblast, Russian Federation, 650056
        • Kemerovo Regional Center for the Prevention and Control of AIDS and Infectious Diseases ( Site 2505)
    • Krasnoyarskiy Kray
      • Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation, 660049
        • Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2504)
    • Leningradskaya Oblast
      • Saint Petersburg, Leningradskaya Oblast, Russian Federation, 196645
        • Republican Clinical Infectious Hospital ( Site 2500)
    • Moskva
      • Moscow, Moskva, Russian Federation, 105275
        • Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2506)
      • Moscow, Moskva, Russian Federation, 115035
        • Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2502)
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 190020
        • Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for Prophylact
    • Tatarstan, Respublika
      • Kazan, Tatarstan, Respublika, Russian Federation, 420140
        • Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2503)
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Josha Research ( Site 2603)
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2013
        • Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 2605)
      • Johannesburg, Gauteng, South Africa, 2092
        • Helen Joseph Hospital-Clinical HIV Research Unit ( Site 2609)
      • Johannesburg, Gauteng, South Africa, 2193
        • Ezintsha-Clinical Research Site ( Site 2607)
      • Pretoria, Gauteng, South Africa, 0083
        • Private Practice Dr. Marleen de Jager ( Site 2600)
    • Kwazulu-Natal
      • Durban, Kwazulu-Natal, South Africa, 4052
        • Wentworth Hospital ( Site 2604)
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7505
        • Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 2608)
      • Cape Town, Western Cape, South Africa, 7925
        • Desmond Tutu Health Foundation ( Site 2602)
      • Paarl, Western Cape, South Africa, 7646
        • Be Part Yoluntu Centre ( Site 2601)
  • Switzerland
      • Berne, Switzerland, 3010
        • Inselspital Bern-Inselspital Infektiologie ( Site 2803)
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4056
        • University Hospital Basel-Infectiology ( Site 2802)
    • Geneve
      • Genève, Geneve, Switzerland, 1211
        • Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2804)
    • Sankt Gallen
      • st.Gallen, Sankt Gallen, Switzerland, 9007
        • Cantonal Hospital St.Gallen ( Site 2801)
    • Ticino
      • Lugano, Ticino, Switzerland, 6903
        • Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 2805)
    • Zurich
      • Zürich, Zurich, Switzerland, 8091
        • UniversitätsSpital Zürich ( Site 2800)
  • Taiwan
      • Kaohsiung, Taiwan, 81362
        • Kaohsiung Veterans General Hospital ( Site 2901)
  • United Kingdom
    • Brighton And Hove
      • East Sussex, Brighton And Hove, United Kingdom, BN2 1ES
        • University Hospitals Sussex NHS Foundation Trust ( Site 3004)
    • Bristol, City Of
      • Bristol, Bristol, City Of, United Kingdom, BS10 5NB
        • Southmead Hospital ( Site 3003)
    • England
      • London, England, United Kingdom, NW32QG
        • Royal Free Hospital ( Site 3002)
    • London, City Of
      • London, London, City Of, United Kingdom, SE5 9RL
        • King's College Hospital ( Site 3001)
    • Manchester
      • Crumpsall, Manchester, United Kingdom, M8 5RB
        • North Manchester General Hospital ( Site 3005)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35222
        • University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 3104)
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Pueblo Family Physicians ( Site 3102)
    • California
      • Beverly Hills, California, United States, 90211
        • Pacific Oaks Medical Group ( Site 3123)
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente ( Site 3124)
      • Los Angeles, California, United States, 90036
        • Ruane Clinical Research Group, Inc ( Site 3126)
      • Los Angeles, California, United States, 90069
        • Mills Clinical Research ( Site 3114)
      • Sacramento, California, United States, 95817
        • University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137)
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center ( Site 3130)
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Therafirst Medical Center ( Site 3110)
      • Fort Pierce, Florida, United States, 34982
        • Midway Immunology and Research Center ( Site 3117)
      • Miami, Florida, United States, 33133
        • AHF The Kinder Medical Group ( Site 3108)
      • Miami Lakes, Florida, United States, 33016
        • Floridian Clinical Research, LLC ( Site 3133)
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center ( Site 3106)
      • Orlando, Florida, United States, 32806
        • Bliss Healthcare Services ( Site 3115)
      • Sarasota, Florida, United States, 34237
        • CAN Community Health - Sarasota ( Site 3118)
      • West Palm Beach, Florida, United States, 33407
        • Triple O Research Institute, P.A ( Site 3116)
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University-Infectious Diseases ( Site 3135)
      • Decatur, Georgia, United States, 30033
        • Infectious Disease Specialists of Atlanta ( Site 3128)
      • Macon, Georgia, United States, 31201
        • Mercer university, Department of internal medicine-Clinical Research ( Site 3129)
      • Savannah, Georgia, United States, 31401
        • Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3105)
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • KC CARE Health Center ( Site 3103)
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • ID Care ( Site 3131)
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 3134)
    • 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 3121)
      • Dallas, Texas, United States, 75246
        • North Texas Infectious Diseases Consultants, P.A ( Site 3100)
      • Fort Worth, Texas, United States, 76104
        • Texas Centers for Infectious Disease Associates ( Site 3111)
      • Houston, Texas, United States, 77098
        • The Crofoot Research Center ( Site 3101)
      • Longview, Texas, United States, 75605
        • DCOL Center for Clinical Research ( Site 3119)
    • Washington
      • Seattle, Washington, United States, 98104
        • Private Practice - Dr. Peter Shalit ( Site 3120)
      • Spokane, Washington, United States, 99202
        • Multicare Institute for Research and Innovation ( Site 3127)

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp & Dohme (MSD)-sponsored clinical studies (MK-8591A-017, -018, -020, and -033 [except for heavily treatment-experienced (HTE) participants]).

Exclusion Criteria:

  • Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-017 /-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033.
  • Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL.
  • Is a HTE participant receiving treatment in MK-8591A-019 or -033.

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: DOR/ISL
Participants will receive fixed dose combination (FDC) tablet of DOR/ISL (100 mg/0.25 mg) taken once daily (QD) orally from Day 1 to Week 96.
Drug: DOR/ISL
FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily
Other Names:
  • MK-8591A
  • Doravirine/islatravir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with One or More Adverse Event (AE)
Time Frame: Up to 102 Weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE through Week 102 will be presented.
Up to 102 Weeks
Percentage of participants who Discontinue Study Intervention Due to an AE
Time Frame: Up to 96 Weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE through Week 96 will be presented.
Up to 96 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with HIV-1 Ribonucleic Acid (RNA) ≥50 copies/mL at Week 96
Time Frame: Week 96
The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 will be reported.
Week 96
Percentage of Participants with HIV-1 RNA <50 copies/mL at Week 96
Time Frame: Week 96
The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 will be reported.
Week 96
Percentage of Participants with HIV-1 RNA ≥200 copies/mL at Week 96
Time Frame: Week 96
The percentage of participants with HIV-1 RNA ≥200 copies/mL at Week 96 will be reported
Week 96
Percentage of Participants with Evidence of Viral Drug Resistance-Associated Substitutions
Time Frame: Up to Week 96
Viral drug resistance is defined as participants with HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic data showing evidence of resistance to the study intervention. The percentage of participants who demonstrate drug resistance through Week 96 will be presented.
Up to Week 96

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)

March 17, 2023

Primary Completion (Estimated)

January 14, 2026

Study Completion (Estimated)

January 14, 2026

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8591A-054
  • MK-8591A-054 (Other Identifier: Merck)
  • 2022-502126-40-00 (Registry Identifier: EU CT)
  • jRCT2051230002 (Registry Identifier: jRCT)

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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