Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)

• ClinicalTrials.gov Identifier: NCT04233216
• Recruitment Status: Active, not recruiting
• First Posted: January 18, 2020
• Last Update Posted: January 6, 2023
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Study Description

Brief Summary:

This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily treatment-experienced (HTE) participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that the percentage of participants receiving DOR/ISL to achieve ≥0.5 log10 decrease in HIV-1 ribonucleic acid (RNA) from study baseline (Day 1) to Day 8 is superior to placebo, each given in combination with failing antiretroviral therapy (ART).

Condition or disease	Intervention/treatment	Phase
HIV-1 Infection	Drug: ISL; Drug: DOR; Drug: DOR/ISL; Drug: Placebo to ISL; Drug: Placebo to DOR	Phase 3

Detailed Description:

Part 1 of this study (Day 1 to Day 7) is the double-blind period in which participants receive either ISL, DOR, DOR/ISL, or placebo. Part 2 of this study (Day 8 to Week 97) is the open-label period in which all participants receive DOR/ISL + optimized background therapy (OBT).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Randomized, Clinical Study in HIV-1-Infected Heavily Treatment-Experienced Participants Evaluating the Antiretroviral Activity of Blinded Islatravir (ISL), Doravirine (DOR), and Doravirine/Islatravir (DOR/ISL), Each Compared to Placebo, and the Antiretroviral Activity, Safety, and Tolerability of Open-Label DOR/ISL
• Actual Study Start Date: March 18, 2020
• Actual Primary Completion Date: November 21, 2022
• Estimated Study Completion Date: October 17, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Part 1, Group 1: ISL + ART; HTE participants with HIV-1 infection take ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7 in Part 1.	Drug: ISL; ISL 0.75 mg capsule taken by mouth.; Other Names: Islatravir; MK-8591
Experimental: Part 1, Group 2: DOR + ART; HTE participants with HIV-1 infection take DOR 100 mg QD in combination with failing ART from Day 1 to Day 7 in Part 1.	Drug: DOR; DOR 100 mg tablet taken by mouth.; Other Names: Doravirine; MK-1439
Experimental: Part 1, Group 3: DOR/ISL + ART; HTE participants with HIV-1 infection take 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7 in Part 1.	Drug: DOR/ISL; 100 mg DOR/0.75 mg ISL FDC taken by mouth.; Other Names: Doravirine/Islatravir; MK-8591A
Placebo Comparator: Part 1, Group 4: Placebo + ART; HTE participants with HIV-1 infection take placebo QD in combination with failing ART from Day 1 to Day 7 in Part 1.	Drug: Placebo to ISL; Placebo capsule matched to ISL taken by mouth.; Drug: Placebo to DOR; Placebo tablet matched to DOR taken by mouth.
Experimental: Part 2, Group 5: Open-Label DOR/ISL + OBT; HTE participants from Groups 1 to 4 with HIV-1 infection take open-label 100 mg DOR/0.75 mg ISL + OBT in Part 2 (Day 8 to Week 97).	Drug: DOR/ISL; 100 mg DOR/0.75 mg ISL FDC taken by mouth.; Other Names: Doravirine/Islatravir; MK-8591A

Outcome Measures

Primary Outcome Measures :

1. Percentage of participants receiving doravirine/islatravir (DOR/ISL) with ≥0.5 log10 decrease from baseline in human immunodificiency virus type 1 (HIV-1) ribonucleic acid (RNA) compared to placebo treatment [ Time Frame: Day 1 (baseline) and Day 8 ]
   The change from baseline in HIV-1 RNA will be determined at the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay with a lower limit of detection (LLOD) of 40 copies/mL.
2. Percentage of participants with ≥1 adverse events (AEs) [ Time Frame: Up to 49 weeks ]
   An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
3. Percentage of participants withdrawing from study treatment due to AE(s) [ Time Frame: Up to 49 weeks ]
   An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Secondary Outcome Measures :

1. Percentage of participants with ≥1 adverse events (AEs) [ Time Frame: Up to 97 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.
2. Percentage of participants discontinuing from study therapy due to AE(s) [ Time Frame: Up to 97 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.
3. Percentage of participants receiving DOR or ISL (given with antiretoviral therapy [ART]) with ≥0.5 log10 decrease in HIV-1 RNA compared to placebo treatment [ Time Frame: Day 1 (baseline) and Day 8 ]
   The percentage of participants with ≥0.5 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
4. Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART), DOR, or ISL compared to placebo treatment [ Time Frame: Day 1 (baseline) and Day 8 ]
   The mean change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
5. Percentage of participants receiving DOR/ISL (given with ART), DOR, or ISL with ≥1.0 log10 decrease from baseline in HIV-1 RNA compared to placebo treatment [ Time Frame: Day 1 (baseline) and Day 8 ]
   The percentage of participants with ≥1.0 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
6. Percentage of participants receiving DOR/ISL (given with ART) with ≥0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment [ Time Frame: Day 1 (baseline) and Day 8 ]
   The percentage of participants with ≥0.5 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
7. Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) compared to DOR or ISL treatment [ Time Frame: Day 1 (baseline) and Day 8 ]
   The mean change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
8. Percentage of participants receiving DOR/ISL (given with ART) with ≥1.0 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment [ Time Frame: Day 1 (baseline) and Day 8 ]
   The percentage of participants with ≥1.0 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
9. Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment [ Time Frame: Day 8 (baseline) and Week 25 ]
   The percentage of participants with ≥0.5 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
10. Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment [ Time Frame: Day 1 (baseline) and Week 49 ]
    The percentage of participants with ≥0.5 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
11. Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment [ Time Frame: Day 1 (baseline) and Week 97 ]
    The percentage of participants with ≥0.5 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
12. Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥1.0 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment [ Time Frame: Day 8 (baseline) and Week 25 ]
    The percentage of participants with ≥1.0 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
13. Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥1.0 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment [ Time Frame: Day 1 (baseline) and Week 49 ]
    The percentage of participants with ≥1.0 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
14. Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥1.0 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment [ Time Frame: Day 1 (baseline) and Week 97 ]
    The percentage of participants with ≥1.0 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
15. Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT [ Time Frame: Day 8 (baseline) and Week 25 ]
    The mean change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
16. Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT [ Time Frame: Day 1 (baseline) and Week 49 ]
    The mean change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
17. Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT [ Time Frame: Day 8 (baseline) and Week 97 ]
    The mean change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
18. Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <200 copies mL [ Time Frame: Day 8 (baseline) and Week 25 ]
    The percentage of participants with HIV-1 RNA <200 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
19. Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <200 copies mL [ Time Frame: Day 1 (baseline) and Week 49 ]
    The percentage of participants with HIV-1 RNA <200 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
20. Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <200 copies mL [ Time Frame: Day 1 (baseline) and Week 97 ]
    The percentage of participants with HIV-1 RNA <200 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
21. Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <50 copies mL [ Time Frame: Day 8 (baseline) and Week 25 ]
    The percentage of participants with HIV-1 RNA <50 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
22. Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <50 copies mL [ Time Frame: Day 1 (baseline) and Week 49 ]
    The percentage of participants with HIV-1 RNA <50 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
23. Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <50 copies mL [ Time Frame: Day 1 (baseline) and Week 97 ]
    The percentage of participants with HIV-1 RNA <50 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
24. Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <40 copies mL [ Time Frame: Day 8 (baseline) and Week 25 ]
    The percentage of participants with HIV-1 RNA <40 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
25. Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <40 copies mL [ Time Frame: Day 1 (baseline) and Week 49 ]
    The percentage of participants with HIV-1 RNA <40 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
26. Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <40 copies mL [ Time Frame: Day 1 (baseline) and Week 97 ]
    The percentage of participants with HIV-1 RNA <40 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
27. Prevalence of viral drug resistance to DOR [ Time Frame: Week 25 ]
    The prevalence of viral drug resistance to DOR will be determined. Viral resistance testing will be performed by the central laboratory.
28. Prevalence of viral drug resistance to DOR [ Time Frame: Week 49 ]
    The prevalence of viral drug resistance to DOR will be determined. Viral resistance testing will be performed by the central laboratory.
29. Prevalence of viral drug resistance to ISL [ Time Frame: Week 25 ]
    The prevalence of viral drug resistance to ISL will be determined. Viral resistance testing will be performed by the central laboratory.
30. Prevalence of viral drug resistance to ISL [ Time Frame: Week 49 ]
    The prevalence of viral drug resistance to ISL will be determined. Viral resistance testing will be performed by the central laboratory.
31. Prevalence of viral drug resistance to optimized background therapy (OBT) components [ Time Frame: Week 25 ]
    The prevalence of viral drug resistance to OBT components will be determined. Viral resistance testing will be performed by the central laboratory.
32. Prevalence of viral drug resistance to OBT components [ Time Frame: Week 49 ]
    The prevalence of viral drug resistance to OBT components will be determined. Viral resistance testing will be performed by the central laboratory.
33. Role of baseline antiviral resistance on viral resistance-associated substitutions (RASs) [ Time Frame: Day 1 (baseline) and Week 25 ]
    The role of baseline antiviral resistance on viral RAS will be determined.
34. Role of baseline antiviral resistance on viral RASs [ Time Frame: Day 1 (baseline) and Week 49 ]
    The role of baseline antiviral resistance on viral RAS will be determined.
35. Role of baseline antiviral resistance on viral RASs [ Time Frame: Day 1 (baseline) and Week 97 ]
    The role of baseline antiviral resistance on viral RAS will be determined.
36. Role of baseline antiviral resistance on HIV-1 RNA [ Time Frame: Day 8 (baseline) and Week 25 ]
    The role of baseline antiviral resistance on HIV-1 RNA will be determined.
37. Role of baseline antiviral resistance on HIV-1 RNA [ Time Frame: Day 8 (baseline) and Week 49 ]
    The role of baseline antiviral resistance on HIV-1 RNA will be determined.
38. Role of baseline antiviral resistance on HIV-1 RNA [ Time Frame: Day 8 (baseline) and Week 97 ]
    The role of baseline antiviral resistance on HIV-1 RNA will be determined.
39. Change from baseline in cluster of differentiation 4+ (CD4+) T-cell counts [ Time Frame: Day 1 (baseline) and Week 25 ]
    The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
40. Change from baseline in CD4+ T-cell counts [ Time Frame: Day 1 (baseline) and Week 49 ]
    The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
41. Change from baseline in CD4+ T-cell counts [ Time Frame: Day 1 (baseline) and Week 97 ]
    The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
42. Change from baseline in CD4+ T-cell counts [ Time Frame: Day 8 (baseline) and Week 25 ]
    The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
43. Change from baseline in CD4+ T-cell counts [ Time Frame: Day 8 (baseline) and Week 49 ]
    The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
44. Change from baseline in CD4+ T-cell counts [ Time Frame: Day 8 (baseline) and Week 97 ]
    The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Is HIV-1 positive.
• Has been receiving the same baseline ART for ≥3 months prior to signing the Informed Consent Form/Assent Form.
• Weighs ≥35 kg.
• Has at least triple-class resistance (must include nucleoside reverse transcriptase inhibitor [NRTI], non-nucleoside reverse transcriptase inhibitor [NNRTI], and resistance to either protease inhibitor (PI) or integrase strand transfer inhibitor (InSTI), based on central laboratory-based resistance or proviral DNA resistance testing at the Screening Visit, or historical resistance testing within 12 months of screening.
• Has ≤2 fully active antiretroviral drugs remaining among all antiretroviral classes that can be effectively combined to form a viable regimen based on resistance, tolerability, safety, drug access, or acceptability to participant.
• If female, is not pregnant or breastfeeding, and is: 1) not a woman of childbearing potential (WOCBP); 2) a WOCBP and uses an acceptable method of contraception/is abstinent; or 3) a WOCBP and has a negative pregnancy test within 24 hours of the first dose of study medication.

Exclusion Criteria:

• Has HIV 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 hepatitis B virus (HBV) co-infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA] positive) and is not currently being treated for HBV.
• Has a history or current evidence of any condition, therapy (including active TB co-infection), laboratory abnormality or other circumstance (including drug or alcohol abuse or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with study participation for the full study duration.
• Is taking or is anticipated to require any of the prohibited therapies from the Screening Visit and throughout the study treatment period.
• Is taking DOR as part of his/her current failing antiretroviral regimen.
• Is taking efavirenz (EFV), etravirine, or nevirapine.
• Is currently participating in or has participated in an interventional clinical study with an investigational compound or device from the Screening Visit through the study treatment period.
• Is female and is expecting to conceive or donate eggs at any time during the study.

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham 1917 Research Clinic ( Site 4031)

Birmingham, Alabama, United States, 35222

United States, California

Men's Health Foundation ( Site 4018)

Los Angeles, California, United States, 90069

Palmtree Clinical Research, Inc. ( Site 4016)

Palm Springs, California, United States, 92262

United States, Connecticut

Yale School of Medicine ( Site 4007)

New Haven, Connecticut, United States, 06510

United States, District of Columbia

Georgetown University Hospital ( Site 4015)

Washington, District of Columbia, United States, 20007

United States, Florida

The Kinder Medical Group ( Site 4014)

Miami, Florida, United States, 33133

Orlando Immunology Center ( Site 4012)

Orlando, Florida, United States, 32803

Triple O Research Institute, P.A. ( Site 4020)

West Palm Beach, Florida, United States, 33407

United States, Georgia

Chatham County Health Department ( Site 4029)

Savannah, Georgia, United States, 31410

United States, Illinois

Howard Brown Health Center ( Site 4006)

Chicago, Illinois, United States, 60613

Northstar Healthcare ( Site 4004)

Chicago, Illinois, United States, 60657

United States, Maryland

University of Maryland ( Site 4023)

Baltimore, Maryland, United States, 21201

United States, Mississippi

The University of Mississippi Medical Center ( Site 4036)

Jackson, Mississippi, United States, 39216

United States, New Jersey

Saint Michael's Medical Center-Research - Infectious Disease ( Site 4035)

Newark, New Jersey, United States, 07102

United States, New York

Icahn School of Medicine at Mount Sinai ( Site 4000)

New York, New York, United States, 10029

United States, North Carolina

University of North Carolina at Chapel Hill ( Site 4026)

Chapel Hill, North Carolina, United States, 27599

United States, Texas

Saint Hope Foundation, Inc. ( Site 4034)

Bellaire, Texas, United States, 77401

North Texas Infectious Diseases Consultants, PA ( Site 4005)

Dallas, Texas, United States, 75246

United States, Washington

Dr. Peter Shalit, MD ( Site 4002)

Seattle, Washington, United States, 98104

Australia, New South Wales

Holdsworth House Medical Practice ( Site 5300)

Sydney, New South Wales, Australia, 2000

St Vincent's Hospital ( Site 5309)

Sydney, New South Wales, Australia, 2010

Australia, Queensland

Holdsworth House Medical Practice - Brisbane ( Site 5312)

Brisbane, Queensland, Australia, 4006

Australia, Victoria

Monash Health-Monash Medical Centre ( Site 5313)

Clayton, Victoria, Australia, 3168

The Alfred Hospital ( Site 5304)

Melbourne, Victoria, Australia, 3004

Canada, British Columbia

Vancouver ID Research and Care Centre Society ( Site 4100)

Vancouver, British Columbia, Canada, V6Z 2C7

Canada, Ontario

Hamilton Health Sciences ( Site 4115)

Hamilton, Ontario, Canada, L8L 2X2

Ottawa Hospital Research Institute ( Site 4111)

Ottawa, Ontario, Canada, K1H 8L6

Toronto General Hospital - University Health Network ( Site 4105)

Toronto, Ontario, Canada, M5G 2N2

Canada, Quebec

McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 4102)

Montreal, Quebec, Canada, H4A 3J1

Chile

Hospital Dr. Hernan Henriquez Aravena ( Site 4405)

Temuco, Araucania, Chile, 4781151

Fundacion Arriaran ( Site 4401)

Santiago, Region M. De Santiago, Chile, 8360159

Centro Cardiovascular Cardiosur ( Site 4407)

Santiago, Region M. De Santiago, Chile, 8910259

Colombia

Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 4306)

Bogota, Distrito Capital De Bogota, Colombia, 111321

Fundacion Valle del Lili ( Site 4301)

Cali, Valle Del Cauca, Colombia, 760032

France

Hopital Edouard Herriot ( Site 4726)

Lyon, Ain, France, 69003

A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 4724)

Paris, Ain, France, 75018

CHU de Nice Hopital Archet 1 ( Site 4703)

Nice, Alpes-Maritimes, France, 06202

Hopital Europeen Marseille ( Site 4717)

Marseille, Bouches-du-Rhone, France, 13003

CHU de Bordeaux- Hopital Saint Andre ( Site 4715)

Bordeaux, Gironde, France, 33075

CHU de Rouen ( Site 4705)

Rouen, Haute-Normandie, France, 76031

CHU de Montpellier - Hopital Saint-Eloi ( Site 4721)

Montpellier, Herault, France, 34295

Centre Hospitalier de Tourcoing ( Site 4700)

Tourcoing, Nord, France, 59208

Hopital Avicenne ( Site 4702)

Bobigny, Seine-Saint-Denis, France, 93000

Hopital Hotel Dieu [Paris, France] ( Site 4723)

Paris, France, 75004

A.P.H. Paris, Hopital Saint Louis ( Site 4714)

Paris, France, 75010

Germany

Medizinische Hochschule Hannover ( Site 4612)

Hannover, Niedersachsen, Germany, 30625

Universitaetsklinikum Bonn ( Site 4600)

Bonn, Nordrhein-Westfalen, Germany, 53127

Universitaetsklinikum Essen ( Site 4607)

Essen, Nordrhein-Westfalen, Germany, 45122

ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 4603)

Berlin, Germany, 10439

EPIMED GmbH ( Site 4608)

Berlin, Germany, 10787

ICH Study Center GmbH & Co.KG ( Site 4609)

Hamburg, Germany, 20146

Italy

Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 5004)

Modena, Emilia-Romagna, Italy, 41124

Ospedale San Gerardo ASST Monza ( Site 5012)

Monza, Monza E Brianza, Italy, 20900

Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 5001)

Milano, Italy, 20122

Universita' Vita Salute. Ospedale San Raffaele ( Site 5002)

Milano, Italy, 20127

Azienda Ospedaliera San Paolo ( Site 5003)

Milano, Italy, 20142

ASST Fatebenefratelli-Ospedale Sacco ( Site 5000)

Milano, Italy, 20157

IRCCS Policlinico San Matteo ( Site 5010)

Pavia, Italy, 27100

Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 5005)

Roma, Italy, 00149

Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 5006)

Roma, Italy, 00168

Japan

Center Hospital of the National Center for Global Health and Medicine ( Site 5401)

Tokyo, Japan, 162-8655

Korea, Republic of

Pusan National University Hospital ( Site 5503)

Busan, Pusan-Kwangyokshi, Korea, Republic of, 49241

Severance Hospital Yonsei University Health System ( Site 5500)

Seoul, Korea, Republic of, 03722

The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 5502)

Seoul, Korea, Republic of, 06591

Peru

INMENSA ( Site 4506)

Lima, Muni Metro De Lima, Peru, 15046

Via Libre ( Site 4500)

Lima, Peru, 15001

Policlinico Universidad Nacional Mayor de San Marcos ( Site 4501)

Lima, Peru, 15081

Portugal

Hospital de Nossa Senhora da Oliveira- EPE ( Site 4905)

Guimaraes, Braga, Portugal, 4835-044

Hospital Dr. Fernando Fonseca, EPE - Amadora/Sintra ( Site 4902)

Amadora, Lisboa, Portugal, 2720-276

Centro Hospitalar de Lisboa Norte Hospital de Santa Maria ( Site 4913)

Lisboa, Portugal, 1649-035

Hospital Geral de Santo Antonio ( Site 4908)

Porto, Portugal, 4099-001

Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 4907)

Porto, Portugal, 4200-319

Puerto Rico

HOPE Clinical Research ( Site 5700)

San Juan, Puerto Rico, 00909

Russian Federation

Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 5101)

Saint Petersburg, Leningradskaya Oblast, Russian Federation

Infectious Clinical Hospital #2 ( Site 5114)

Moscow, Moskva, Russian Federation, 105275

Gbuz Samarskiy Oblastnoy Klinicheskiy Tsentr Profilaktiki I Bor'by So Spid ( Site 5113)

Samara, Samarskaya Oblast, Russian Federation, 443124

FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 5100)

Saint Petersburg, Sankt-Peterburg, Russian Federation, 196645

Smolensk Center On Aids And Infectious Diseases Prophylaxis ( Site 5115)

Smolensk, Smolenskaya Oblast, Russian Federation, 214006

Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 5106)

Yekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620102

Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 5104)

Kazan, Tatarstan, Respublika, Russian Federation, 420140

South Africa

FARMOVS ( Site 4805)

Bloemfontein, Free State, South Africa, 9301

Wits Clinical HIV Research Unit ( Site 4804)

Johannesburg, Gauteng, South Africa, 2041

Ezintsha ( Site 4806)

Johannesburg, Gauteng, South Africa, 2193

King Edward Hospital ( Site 4802)

Durban, Kwazulu-Natal, South Africa, 4013

Spain

Hospital Universitari Germans Trias i Pujol ( Site 5600)

Badalona, Barcelona, Spain, 08916

Hospital Clinic i Provincial ( Site 5601)

Barcelona, Cataluna, Spain, 08036

Hospital Santa Lucia ( Site 5603)

Cartagena, Murcia, Region De, Spain, 30202

Hospital Universitario La Paz ( Site 5604)

Madrid, Spain, 28046

Ukraine

Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 5619)

Dnipro, Dnipropetrovska Oblast, Ukraine, 49115

Regional Clinical Infectious Hospital ( Site 5614)

Kharkiv, Kharkivska Oblast, Ukraine, 61096

Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 5620)

Kherson, Khersonska Oblast, Ukraine, 73000

Institute of Epidemiology and Infect Diseases of the NAMS of Ukraine ( Site 5615)

Kyiv, Kyivska Oblast, Ukraine, 03038

Mykolaiv center of paliative assistance and integrated services ( Site 5621)

Mykolaiv, Mykolaivska Oblast, Ukraine, 54003

MNE Odesa Regional Center of Socially Significant Diseases ( Site 5611)

Odesa, Odeska Oblast, Ukraine, 65014

MI Vinnytsia Regional Center of AIDS Prevention and Care ( Site 5618)

Berezina, Vinnytska Oblast, Ukraine, 23222

Kyiv City Clinical Hospital 5 ( Site 5616)

Kyiv, Ukraine, 03115

United Kingdom

Royal Free Hospital ( Site 5202)

London, Camden, United Kingdom, NW3 2QG

Western General Hospital ( Site 5201)

Edinburgh, Edinburgh, City Of, United Kingdom, EH4 2XU

Sponsors and Collaborators

Merck Sharp & Dohme LLC

Investigators

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

More Information

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT04233216
• Other Study ID Numbers: 8591A-019; MK-8591A-019 ( Other Identifier: Merck ); 205243 ( Registry Identifier: JAPIC-CTI ); 2019-000588-26 ( EudraCT Number )
• First Posted: January 18, 2020
• Last Update Posted: January 6, 2023
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infections; Islatravir; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Anti-Retroviral Agents