Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)

A Phase 3 Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Antiretroviral Therapy

This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a protocol-specified background antiretroviral regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with baseline antiretroviral therapy (ART) 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 Infection
• Intervention / Treatment: Drug: DOR/ISL; Drug: ART

• Study Type: Interventional
• Enrollment (Actual): 672
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice ( Site 2300)
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 2309)
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Melbourne Sexual Health Centre ( Site 2305)
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital ( Site 2301)
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2R 0X7
      • Southern Alberta HIV Clinic ( Site 1108)
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2C7
      • Vancouver ID Research and Care Centre Society ( Site 1100)
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton Health Sciences ( Site 1103)
    • Toronto, Ontario, Canada, M5G 1K2
      • Maple Leaf Research ( Site 1112)
    • Toronto, Ontario, Canada, M5G 2N2
      • Toronto General Hospital - University Health Network ( Site 1105)
  • Quebec
    • Montreal, Quebec, Canada, H2L 4E9
      • Clinique de Medecine Urbaine du Quartier Latin ( Site 1104)
    • Montreal, Quebec, Canada, H2L 4P9
      • Clinique Medicale L Actuel ( Site 1114)
• Chile
  • Araucania
    • Temuco, Araucania, Chile, 4781151
      • Hospital Dr. Hernan Henriquez Aravena ( Site 1305)
  • Region Metropolitana De Santiago
    • Santiago, Region Metropolitana De Santiago, Chile, 7560994
      • Clinica Arauco Salud ( Site 1300)
    • Santiago, Region Metropolitana De Santiago, Chile, 8330034
      • Centro de Investigacion Clinica UC CICUC ( Site 1303)
• Colombia
  • Valle Del Cauca
    • Cali, Valle Del Cauca, Colombia, 760032
      • Fundacion Valle del Lili ( Site 1201)
• France
  • Paris, France, 75010
    • A.P.H. Paris, Hopital Saint Louis ( Site 2014)
  • Cote-d'Or
    • Dijon, Cote-d'Or, France, 21079
      • Hopital Francois Mitterrand ( Site 2019)
  • Gironde
    • Bordeaux, Gironde, France, 33075
      • CHU de Bordeaux- Hopital Saint Andre ( Site 2015)
  • Haute-Garonne
    • Toulouse, Haute-Garonne, France, 31059
      • CHU de Toulouse - Hopital Purpan ( Site 2004)
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • CHU Hotel Dieu Nantes ( Site 2020)
  • Rhone-Alpes
    • Lyon, Rhone-Alpes, France, 69317
      • Hopital de la Croix-Rousse ( Site 2027)
  • Seine-Maritime
    • Rouen, Seine-Maritime, France, 76031
      • CHU de Rouen ( Site 2005)
• Italy
  • Milano, Italy, 20157
    • ASST Fatebenefratelli-Ospedale Sacco ( Site 2200)
  • Napoli, Italy, 80131
    • A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 2208)
  • Roma, Italy, 00168
    • Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 2206)
• Japan
  • Osaka, Japan, 540-0006
    • National Hospital Organization Osaka National Hospital ( Site 2402)
  • Tokyo, Japan, 113-8677
    • Tokyo Metropolitan Komagome Hospital ( Site 2406)
  • Tokyo, Japan, 160-0023
    • Tokyo Medical University Hospital ( Site 2404)
  • Tokyo, Japan, 162-8655
    • Center Hospital of the National Center for Global Health and Medicine ( Site 2401)
  • Aichi
    • Nagoya, Aichi, Japan, 460-0001
      • National Hospital Organization Nagoya Medical Center ( Site 2403)
• New Zealand
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8011
      • Christchurch Hospital ( Site 2303)
• Poland
  • Wroclaw, Poland, 50-136
    • Wroclawskie Centrum Zdrowia SP ZOZ ( Site 1507)
  • Dolnoslaskie
    • Wroclaw, Dolnoslaskie, Poland, 50-220
      • EMC Instytut Medyczny SA Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1500)
  • Lodzkie
    • Lodz-Baluty, Lodzkie, Poland, 91-347
      • Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 1503)
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 01-201
      • SP ZOZ Wojewodzki Szpital Zakazny ( Site 1505)
• Russian Federation
  • Kemerovskaya Oblast'
    • Kemerovo, Kemerovskaya Oblast', Russian Federation, 650056
      • Kemerovo Regional Center for the Prevention and Control of AIDS ( Site 1713)
  • Krasnoyarskiy Kray
    • Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation, 660049
      • Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 1712)
  • Leningradskaya Oblast'
    • Saint Petersburg, Leningradskaya Oblast', Russian Federation, 190020
      • Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 1701)
  • Moskva
    • Moscow, Moskva, Russian Federation, 105275
      • Federal Scientific Methodological AIDS Prevention and Control Center ( Site 1703)
    • Moscow, Moskva, Russian Federation, 105275
      • Infectious Clinical Hospital #2 ( Site 1719)
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russian Federation, 196645
      • FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 1700)
  • Sverdlovskaya Oblast'
    • Yekaterinburg, Sverdlovskaya Oblast', Russian Federation, 620102
      • Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 1715)
  • Tatarstan, Respublika
    • Kazan, Tatarstan, Respublika, Russian Federation, 420140
      • Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 1707)
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • JOSHA Research ( Site 1406)
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7925
      • Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1414)
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial ( Site 1600)
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon ( Site 1603)
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor ( Site 1601)
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz ( Site 1602)
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz ( Site 1604)
  • Alicante
    • Elche, Alicante, Spain, 03202
      • Hospital General de Elche ( Site 1608)
  • Barcelona [Barcelona]
    • Badalona, Barcelona [Barcelona], Spain, 08916
      • Hospital Universitari Germans Trias i Pujol ( Site 1606)
• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • Universitaetsspital Basel ( Site 3302)
  • Berne
    • Bern, Berne, Switzerland, 3010
      • Inselspital Universitaetsspital Bern ( Site 3303)
  • Geneve
    • Geneva, Geneve, Switzerland, 1211
      • Hopitaux Universitaires de Geneve HUG. ( Site 3304)
  • Sankt Gallen
    • St. Gallen, Sankt Gallen, Switzerland, 9007
      • Kantonsspital St. Gallen ( Site 3301)
  • Ticino
    • Lugano, Ticino, Switzerland, 6903
      • Ospedale Regionale di Lugano Civico ( Site 3305)
  • Zurich
    • Zuerich, Zurich, Switzerland, 8091
      • Universitaetsspital Zuerich ( Site 3300)
• United Kingdom
  • Manchester, United Kingdom, M8 5RB
    • North Manchester General Hospital ( Site 1902)
  • Brighton And Hove
    • Brighton, Brighton And Hove, United Kingdom, BN2 1ES
      • Brighton and Sussex University Hospital NHS Trust ( Site 1908)
  • Bristol, City Of
    • Bristol, Bristol, City Of, United Kingdom, BS10 5NB
      • Southmead Hospital ( Site 1910)
  • Camden
    • London, Camden, United Kingdom, NW3 2QG
      • Royal Free Hospital ( Site 1904)
  • London, City Of
    • London, London, City Of, United Kingdom, SE5 9RJ
      • Kings College Hospital NHS Foundation Trust ( Site 1907)
• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Hospital ( Site 1018)
  • Florida
    • Fort Pierce, Florida, United States, 34982
      • Midway Immunology and Research ( Site 1030)
    • Orlando, Florida, United States, 32803
      • Orlando Immunology Center ( Site 1007)
    • Orlando, Florida, United States, 32806
      • Bliss Healthcare Services ( Site 1025)
    • West Palm Beach, Florida, United States, 33407
      • Triple O Research Institute, P.A. ( Site 1026)
  • Georgia
    • Savannah, Georgia, United States, 31401
      • Chatham County Health Department ( Site 1043)
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Northstar Healthcare ( Site 1002)
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Kansas City CARE Health Center ( Site 1008)
  • New Jersey
    • Hillsborough, New Jersey, United States, 08844
      • ID Care ( Site 1023)
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill ( Site 1042)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania ( Site 1038)
  • Texas
    • Bellaire, Texas, United States, 77401
      • Saint Hope Foundation, Inc. ( Site 1037)
    • Dallas, Texas, United States, 75246
      • North Texas ID Consultants, PA ( Site 1003)
    • Fort Worth, Texas, United States, 76104
      • Texas Centers for Infectious Disease Associates P.A. ( Site 1022)
    • Houston, Texas, United States, 77098
      • The Crofoot Research Center, Inc. ( Site 1005)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Is HIV-1 positive
• Has been receiving continuous, stable oral 2-drug or 3-drug combination (± pharmacokinetic (PK) booster) with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen.
• Female is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; 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; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive

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 an active diagnosis of hepatitis due to any cause, including active Hepatitis B Virus (HBV) co-infection
• 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
• Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies
• Is currently taking long-acting cabotegravir-rilpivirine
• 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 treatment period
• Has a documented or known virologic resistance to DOR
• Female expects to conceive or donate eggs at any time during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Doravirine/Islatravir (DOR/ISL); Participants who were previously treated with continuous background antiretroviral therapy (ART) will receive DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Drug: DOR/ISL; A FDC of 100 mg DOR/ 0.75 mg ISL taken in tablet form, orally, once daily; Other Names: MK-8591A
Active Comparator: Baseline Background Antiretroviral Therapy (ART); Participants will receive continuous background ART for 48 weeks and DOR/ISL, a FDC of 100 mg DOR/0.75 mg ISL orally once daily for 48 weeks.	Drug: DOR/ISL; A FDC of 100 mg DOR/ 0.75 mg ISL taken in tablet form, orally, once daily; Other Names: MK-8591A; Drug: ART; Baseline background ART regimen will be administered as per approved label. ART medication will not be provided by the Sponsor; participants will provide their own ART medications. Allowed drug classes include nucleoside analog reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transferase inhibitors (InSTIs), fusion inhibitors, chemokine receptor 5 (CCR5) antagonists, post-attachment inhibitor, and pharmacokinetic (PK) boosters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) ≥50 Copies/mL at Week 48	HIV-1 RNA levels in blood samples taken at each visit were measured by the Abbott RealTime polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.	Week 48
Percentage of Participants With One or More Adverse Events (AEs) up to Week 48	An AE was defined as 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. The percentage of participants who experienced at least one AE was reported.	Up to ~48 Weeks
Percentage of Participants Who Discontinued Study Intervention up to Week 48	An AE was defined as 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. The percentage of participants who discontinued study intervention due to an AE was reported.	Up to ~48 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 48	HIV-1 RNA levels in blood samples taken at each visit were measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA <40 copies/mL or <50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.	Week 48
Percentage of Participants With HIV-1 RNA ≥50 Copies/mL, <40 Copies/mL or <50 Copies/mL From Week 48 to Week 96	HIV-1 RNA levels in blood samples taken at each visit will be measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL, <40 copies/mL, or <50 copies/mL from Week 48 to Week 96 will be presented using the FDA Snapshot missing data approach.	Weeks 48-96 (up to ~48 weeks)
Percentage of Participants With HIV-1 RNA ≥50 Copies/mL, <40 Copies/mL or <50 Copies/mL at Week 96	HIV-1 RNA levels in blood samples taken at each visit will be measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL, <40 copies/mL, or <50 copies/mL at Week 96 will be presented using the FDA Snapshot missing data approach.	Week 96
Percentage Change From Baseline in CD4+ T-cell Count at Week 48	Plasma CD4+ T-Cell Count was measured in cells/mm^3 for baseline and 48 weeks. Baseline measurements were defined as the Day 1 value of each participant. The percentage change from baseline to Week 48 is presented.	Baseline and Week 48
Percentage Change From Baseline in CD4+ T-cell Count at Week 96	Plasma CD4+ T-Cell Count will be measured in cells/mm^3 for baseline and 96 weeks. Baseline measurements will be defined as the Day 1 value of each participant. The percentage change from baseline to Week 96 will be presented.	Baseline and Week 96
Percentage Change From Week 48 in CD4+ T-cell Count at Week 96	Plasma CD4+ T-Cell Count will be measured in cells/mm^3 for Week 48 and Week 96. The percentage change from Week 48 to Week 96 will be presented.	Week 48 and Week 96
Percentage of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 48	Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrated drug resistance at Week 48 is presented.	Week 48
Percentage of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96	Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance at Week 96 will be presented.	Week 96
Change From Baseline to Week 24 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens)	Blood serum samples were taken at baseline and Week 24. Per protocol, this outcome analysis was conducted in participants on PI-containing regimens (including PI- and InSTI-containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 24 in fasting lipids is presented.	Baseline and Week 24
Change From Baseline to Week 24 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens)	Blood serum samples were taken at baseline and Week 24. Per protocol, this outcome analysis was conducted in participants on InSTI-based regimens (non-PI containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 24 in fasting lipids is presented.	Baseline and Week 24
Change From Baseline to Week 24 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens	Blood serum samples were taken at baseline and Week 24. Per protocol, this outcome analysis was conducted in participants on all other non-PI- and non-InSTI containing regimens, excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 24 in fasting lipids is presented.	Baseline and Week 24
Change From Baseline to Week 48 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens)	Blood serum samples were taken at baseline and Week 48. Per protocol, this outcome analysis was conducted in participants on PI-containing regimens (including PI- and InSTI-containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 48 in fasting lipids is presented.	Baseline and Week 48
Change From Baseline to Week 48 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens)	Blood serum samples were taken at baseline and Week 48. Per protocol, this outcome analysis was conducted in participants on InSTI-based regimens (non-PI containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 48 in fasting lipids is presented.	Baseline and Week 48
Change From Baseline to Week 48 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens	Blood serum samples were taken at baseline and Week 48. Per protocol, this outcome analysis was conducted in participants on all other non-PI- and non-InSTI containing regimens, excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 48 in fasting lipids is presented.	Baseline and Week 48
Change From Baseline in Body Weight at Week 48 for InSTI-based Regimens (Non-PI-containing Regimens)	Baseline measurements were defined as the Day 1 value of each participant. The change from baseline to Week 48 is presented for participants who received InSTI- based regimens.	Baseline and Week 48
Percentage of Participants With One or More AEs up to Week 96	An AE is defined as 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. The percentage of participants who experience at least one AE will be reported.	Up to ~96 Weeks
Percentage of Participants Who Discontinued Study Intervention up to Week 96	An AE is defined as 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. The percentage of participants who discontinue study intervention due to an AE will be reported.	Up to ~96 Weeks
Percentage of Participants With One or More AEs From Week 48 to Week 96	An AE is defined as 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. The percentage of participants who experience at least one AE will be reported.	Weeks 48-96
Percentage of Participants Who Discontinued Study Intervention From Week 48 to Week 96	An AE is defined as 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. The percentage of participants who discontinue study intervention due to an AE will be reported.	Weeks 48-96

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

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2020
• Primary Completion (Actual): September 8, 2021
• Study Completion (Estimated): November 22, 2024

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; 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-017; MK-8591A-017 (Other Identifier: Merck); 205165 (Registry Identifier: JAPIC-CTI); 2019-000586-20 (EudraCT Number)

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