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

A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV-1 Infection
• Intervention / Treatment: Drug: DOR/ISL; Drug: Placebo to BIC/FTC/TAF; Drug: BIC/FTC/TAF; Drug: Placebo to DOR/ISL

• Study Type: Interventional
• Enrollment (Actual): 537
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1405CKC
    • Fundación IDEAA ( Site 5851)
  • Córdoba, Argentina, X5000JJS
    • Instituto Oulton ( Site 5853)
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, C1427CEA
      • Fundación Huésped ( Site 5850)
    • Mar del Plata, Buenos Aires, Argentina, B7600FZO
      • Instituto de Investigaciones Clínicas Mar del Plata ( Site 5854)
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000PBJ
      • Instituto CAICI SRL ( Site 5852)
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 1A4
      • Hamilton Health Sciences-Urgent Care Centre ( Site 5750)
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital ( Site 5753)
  • Quebec
    • Montreal, Quebec, Canada, H2L 4P9
      • Clinique Medicale lActuel ( Site 5752)
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre ( Site 5751)
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4P 0W5
      • Regina General Hospital ( Site 5754)
• Chile
  • Maule Region
    • Talca, Maule Region, Chile, 3465584
      • Clinica Universidad Catolica del Maule ( Site 5954)
  • Region M. de Santiago
    • Santiago, Region M. de Santiago, Chile, 7500710
      • Biomedica Research Group-Infectology ( Site 5951)
    • Santiago, Region M. de Santiago, Chile, 7770086
      • Espacio Eme ( Site 5952)
    • Santiago, Region M. de Santiago, Chile, 8330034
      • Centro de Investigacion Clinicadela Universidad Catolica ( Site 5953)
    • Santiago, Region M. de Santiago, Chile, 8380420
      • Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 5950)
  • Región de la Araucanía
    • Temuco, Región de la Araucanía, Chile, 4781151
      • Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 5955)
• Colombia
  • Atlántico
    • Barranquilla, Atlántico, Colombia, 08001
      • Ciensalud Ips S A S ( Site 6050)
    • Barranquilla, Atlántico, Colombia, 080020
      • Clinica de la Costa S.A.S. ( Site 6055)
  • Bogota D.C.
    • Bogotá, Bogota D.C., Colombia, 110231
      • Hospital Universitario San Ignacio-Infectious ( Site 6053)
    • Bogotá, Bogota D.C., Colombia, 111321
      • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 6051)
  • Valle del Cauca Department
    • Cali, Valle del Cauca Department, Colombia, 760032
      • Fundación Valle del Lili ( Site 6052)
• Dominican Republic
  • Santo Domingo Province
    • Santo Domingo de Guzman, Santo Domingo Province, Dominican Republic, 10305
      • Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 8250)
• France
  • Paris, France, 75018
    • Hôpital Bichat - Claude-Bernard ( Site 6162)
  • Paris, France, 75571
    • Hôpital Saint Antoine ( Site 6158)
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06202
      • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 6153)
  • Nord
    • Tourcoing, Nord, France, 59200
      • Tourcoing Hospital ( Site 6150)
  • Île-de-France Region
    • Bobigny, Île-de-France Region, France, 93000
      • Hôpital Avicenne ( Site 6160)
    • Paris, Île-de-France Region, France, 75010
      • Hôpital Saint-Louis ( Site 6159)
    • Paris, Île-de-France Region, France, 75013
      • Pitie Salpetriere University Hospital ( Site 6156)
• Germany
  • Hamburg, Germany, 20146
    • ICH Study Center GmbH & Co. KG ( Site 6259)
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 6260)
  • Bavaria
    • München, Bavaria, Germany, 80336
      • Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik und Poliklinik IV, Sektio
  • Brandenburg
    • Freiburg, Brandenburg, Germany, 79106
      • Universitaetsklinikum Freiburg ( Site 6256)
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53127
      • Universitätsklinikum Bonn-Immunologie ( Site 6250)
• Guatemala
  • Guatemala City, Guatemala, 01001
    • CLINIPHARM ( Site 8352)
  • Guatemala City, Guatemala, 01009
    • Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 8350)
  • Guatemala City, Guatemala, 01010
    • CELAN,S.A ( Site 8351)
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 6751)
  • Jerusalem, Israel, 9120
    • Hadassah Medical Center-Infecious Disease ( Site 6752)
  • Ramat Gan, Israel, 5262100
    • Sheba Medical Center-HIV unit ( Site 6753)
  • Tel Aviv, Israel, 6423906
    • Sourasky Medical Center ( Site 6754)
• Japan
  • Osaka, Japan, 540-0006
    • National Hospital Organization Osaka National Hospital ( Site 6952)
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 460-0001
      • National Hospital Organization Nagoya Medical Center ( Site 6953)
  • Tokyo
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Tokyo Medical University Hospital ( Site 6954)
    • Shinjyuku-ku, Tokyo, Japan, 162-8655
      • Center Hospital of the National Center for Global Health and Medicine ( Site 6951)
• Kenya
  • Kisumu, Kenya, 40100
    • KEMRI-CMR-RCTP ( Site 8650)
  • Nairobi City
    • Nairobi, Nairobi City, Kenya, 00200
      • CCR KEMRI (Center for Clinical Research) ( Site 8652)
    • Nairobi, Nairobi City, Kenya, 00202
      • PHRD KEMRI (Partners in Health Research & Development) ( Site 8651)
• Malaysia
  • Kuala Lumpur, Malaysia, 50586
    • Hospital Kuala Lumpur ( Site 7773)
  • Kedah
    • Alor Star, Kedah, Malaysia, 05460
      • Hospital Sultanah Bahiyah ( Site 7776)
  • Kuala Lumpur
    • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
      • University Malaya Medical Centre-Clinical Investigation Centre (CIC) ( Site 7777)
  • Pulau Pinang
    • George Town, Pulau Pinang, Malaysia, 10450
      • Hospital Pulau Pinang ( Site 7779)
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • Sarawak General Hospital ( Site 7772)
  • Selangor
    • Batu Caves, Selangor, Malaysia, 68100
      • Hospital Selayang ( Site 7770)
    • Sungai Buloh, Selangor, Malaysia, 47000
      • Hospital Sungai Buloh ( Site 7778)
• Mexico
  • Mexico City
    • Mexico City, Mexico City, Mexico, 14080
      • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 7251)
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Ponce Medical School Foundation Inc. ( Site 7452)
  • San Juan, Puerto Rico, 00909
    • Clinical Research Puerto Rico ( Site 7450)
  • San Juan, Puerto Rico, 00909
    • HOPE Clinical Research ( Site 7451)
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • Josha Research ( Site 6652)
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2013
      • Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 6654)
    • Johannesburg, Gauteng, South Africa, 2092
      • Helen Joseph Hospital-Clinical HIV Research Unit ( Site 6661)
    • Johannesburg, Gauteng, South Africa, 2193
      • Ezintsha-Clinical Research Site ( Site 6656)
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4052
      • Wentworth Hospital ( Site 6653)
    • Ladysmith, KwaZulu-Natal, South Africa, 3370
      • Qhakaza Mbokodo Research Clinic ( Site 6659)
    • Pietermaritzburg, KwaZulu-Natal, South Africa, 3201
      • Human Sciences Research Council-Centre for Community Based Research ( Site 6664)
  • North West
    • Brits, North West, South Africa, 0250
      • Madibeng Centre for Research ( Site 6660)
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7500
      • Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6657)
    • Cape Town, Western Cape, South Africa, 7925
      • Desmond Tutu Health Foundation ( Site 6651)
    • Paarl, Western Cape, South Africa, 7626
      • Be Part Yoluntu Centre ( Site 6650)
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron-Infectious Diseases: HIV unit ( Site 6352)
  • Madrid, Spain, 28015
    • Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 6357)
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre ( Site 6355)
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz ( Site 6354)
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria ( Site 6359)
  • Alicante
    • Elche, Alicante, Spain, 03202
      • Hospital General Universitario de Elche-Infectius Disease ( Site 6358)
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 6351)
  • Catalonia
    • Barcelona, Catalonia, Spain, 08036
      • HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 6350)
    • L'Hospitalet de Llobregat,Barcelona, Catalonia, Spain, 08907
      • Hospital Universitari de Bellvitge ( Site 6360)
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28007
      • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 6353)
    • Madrid, Madrid, Comunidad de, Spain, 28034
      • Hospital Universitario Ramón y Cajal-ENFERMEDADES INFECCIOSAS ( Site 6361)
• Switzerland
  • Canton of Basel-City
    • Basel, Canton of Basel-City, Switzerland, 4031
      • University Hospital Basel-Infectiology ( Site 8151)
  • Canton of Geneva
    • Geneva, Canton of Geneva, Switzerland, 1205
      • Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 8150)
• Thailand
  • Chiang Mai, Thailand, 50200
    • Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 7852
  • Bangkok
    • Bangkok, Bangkok, Thailand, 10330
      • HIV Netherlands Australia Thailand Research Collaboration ( Site 7851)
    • Bangkok, Bangkok, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 7850)
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 7659)
  • Ankara
    • Altindağ, Ankara, Turkey (Türkiye), 06230
      • Hacettepe Universite Hastaneleri ( Site 7650)
• United Kingdom
  • Bristol, City of
    • Bristol, Bristol, City of, United Kingdom, BS10 5NB
      • Southmead Hospital ( Site 7952)
  • England
    • London, England, United Kingdom, E1 1BB
      • Royal London Hospital ( Site 7951)
    • Manchester, England, United Kingdom, M13 0FH
      • The Hathersage Centre ( Site 7953)
  • London, City of
    • London, London, City of, United Kingdom, SE5 9RL
      • King's College Hospital ( Site 7950)
    • London, London, City of, United Kingdom, WC1E 6JB
      • The Mortimer Market Centre for Sexual Health and HIV Research ( Site 7954)
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Pueblo Family Physicians ( Site 5674)
  • California
    • Beverly Hills, California, United States, 90211
      • Pacific Oaks Medical Group ( Site 5681)
    • Los Angeles, California, United States, 90036
      • Ruane Clinical Research Group, Inc ( Site 5658)
  • Colorado
    • Denver, Colorado, United States, 80246
      • Vivent Health ( Site 5694)
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20017
      • Washington Health Institute ( Site 5689)
  • Florida
    • Ft. Pierce, Florida, United States, 34982
      • Midway Immunology and Research Center ( Site 5657)
    • Miami, Florida, United States, 33133
      • AHF The Kinder Medical Group ( Site 5672)
    • Miami Beach, Florida, United States, 33140
      • AHF South Beach ( Site 5663)
    • Orlando, Florida, United States, 32803
      • Orlando Immunology Center ( Site 5654)
    • Sarasota, Florida, United States, 34237
      • CAN Community Health - Sarasota ( Site 5668)
    • West Palm Beach, Florida, United States, 33407
      • Triple O Research Institute, P.A ( Site 5666)
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University and Grady Health System-Medicine ( Site 5690)
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown Infectious Disease Clinic ( Site 5673)
    • Atlanta, Georgia, United States, 30309
      • Atlanta I.D. Group ( Site 5680)
    • Decatur, Georgia, United States, 30033
      • Metro Infectious Diseases Consultants L.L.C. ( Site 5653)
    • Macon, Georgia, United States, 31201
      • Mercer University, Department of Internal Medicine ( Site 5655)
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center-Infectious Disease ( Site 5671)
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago-Project WISH ( Site 5685)
    • Chicago, Illinois, United States, 60613
      • Howard Brown Health Center-Clinical Research ( Site 5665)
  • Michigan
    • Berkley, Michigan, United States, 48072
      • Be Well Medical Center ( Site 5650)
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital ( Site 5667)
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • KC CARE Health Center-Clinical Trials ( Site 5670)
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Jubilee Clinical Research ( Site 5679)
    • Las Vegas, Nevada, United States, 89106
      • Las Vegas Research Center ( Site 5691)
  • New Jersey
    • Hillsborough, New Jersey, United States, 08844
      • ID Care ( Site 5676)
    • Newark, New Jersey, United States, 07102
      • Saint Michael's Medical Center ( Site 5682)
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center-Division of Infectious Diseases ( Site 5688)
    • The Bronx, New York, United States, 10461
      • Jacobi Medical Center ( Site 5683)
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 5675)
    • Greensboro, North Carolina, United States, 27401
      • Regional Center for Infectious Diseases ( Site 5687)
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0405
      • University of Cincinnati Medical Center-Infectious Diseases - Outpatient ( Site 5662)
  • Texas
    • Austin, Texas, United States, 78705
      • Central Texas Clinical Research ( Site 5661)
    • Bellaire, Texas, United States, 77401
      • St Hope Foundation ( Site 5659)
    • Dallas, Texas, United States, 75208
      • Prism Health North Texas, Oak Cliff Health Center ( Site 5660)
    • Dallas, Texas, United States, 75246
      • North Texas Infectious Diseases Consultants, P.A ( Site 5651)
    • El Paso, Texas, United States, 79902
      • AXCES Research - Texas - El Paso ( Site 5692)
    • Fort Worth, Texas, United States, 76104
      • Texas Centers for Infectious Disease Associates ( Site 5656)
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research ( Site 5664)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DOR/ISL; Participants take DOR/ISL and placebo to BIC/FTC/TAF once daily (qd) for 144 weeks.	Drug: DOR/ISL; Fixed dose combination tablet containing DOR/ISL 100 mg/0.25 mg taken by mouth.; Other Names: MK-8591A; Drug: Placebo to BIC/FTC/TAF; Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth.
Active Comparator: BIC/FTC/TAF; Participants take BIC/FTC/TAF and placebo to DOR/ISL qd for 144 weeks.	Drug: BIC/FTC/TAF; Fixed dose combination tablet containing BIC/FTC/TAF 50 mg/200 mg/25 mg taken by mouth.; Drug: Placebo to DOR/ISL; Placebo tablet matched to DOR/ISL tablet taken by mouth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants experiencing ≥1 adverse event (AE) through Week 48	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.	Up to 48 weeks
Percentage of participants discontinuing from study treatment due to an AE through Week 48	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.	Up to 48 weeks
Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 48	Plasma HIV-1 RNA quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay with a lower limit of detection of <50 copies/mL.	Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96	Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL.	Week 96
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48	Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL.	Week 48
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96	Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL.	Week 96
Change from baseline in cluster of differentiation 4+ (CD4+) T-cells at Week 48	CD4+ T-cells are quantified with a T and B lymphocyte and natural killer cell (TBNK) panel.	Baseline (Day 1) and Week 48
Change from baseline in CD4+ T-cells at Week 96	CD4+ T-cells are quantified with a TBNK panel.	Baseline (Day 1) and Week 96
Incidence of viral drug resistance	Plasma samples will be collected for genotypic and phenotypic HIV-1 viral drug resistance testing and used to assess resistance-associated substitutions and viral susceptibility as applicable during the study.	Up to 96 weeks
Change from baseline in body weight at Week 48	Body weight will be collected throughout the study.	Baseline (Day 1) and Week 48
Change from baseline in body weight at Week 96	Body weight will be collected throughout the study.	Baseline (Day 1) and Week 96
Percentage of participants with HIV-1 RNA <50 copies/mL at Week 144	Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL.	Week 144
Percentage of participants with HIV-1 RNA <200 copies/mL at Week 144	Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of <50 copies/mL.	Week 144
Change from baseline in CD4+ T-cells at Week 144	CD4+ T-cells are quantified with a TBNK panel.	Baseline (Day 1) and Week 144
Change from baseline in body weight at Week 144	Body weight will be collected throughout the study.	Baseline (Day 1) and Week 144
Percentage of participants experiencing ≥1 AE through Week 144	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.	Up to 144 weeks
Percentage of participants discontinuing from study treatment due to an AE through Week 144	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.	Up to 144 weeks

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Actual): October 13, 2025
• Study Completion (Estimated): August 5, 2029

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Estimated): October 23, 2025
• Last Update Submitted That Met QC Criteria: October 21, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Retroviral Agents; Islatravir
• Other Study ID Numbers: 8591A-053; 2022-502099-22-00 (Registry Identifier: EU CT); jRCT2031220720 (Registry Identifier: jRCT); U1111-1283-2516 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/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