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Randomized, Double-blind, Efficacy, and Safety Study of Doravirine/Islatravir (DOR/ISL) in Treatment-naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)

Primary Purpose

HIV-1 Infection

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DOR/ISL
BIC/FTC/TAF
Placebo to BIC/FTC/TAF
Placebo to DOR/ISL
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-1 Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Is HIV-1 positive
  • Is naïve to antiretroviral therapy (ART) defined as having received ≤10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection including prevention of mother-to-child transmission up to 1 month prior to screening.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); 2) Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis); 3) 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; 4) If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required

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 HBV infection (defined as hepatitis B surface antigen [HBsAg]-positive or hepatitis B virus deoxyribonucleic acid [HBV DNA]-positive)
  • 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
  • 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
  • Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1
  • Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapy from 45 days prior to Day 1 through the study intervention period
  • 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 intervention period
  • Has a documented or known virologic resistance to any approved HIV-1 reverse transcriptase inhibitor, or any study intervention
  • Has exclusionary laboratory values within 45 days prior to Day 1
  • Is female and is expecting to conceive or donate eggs at any time during the study

Sites / Locations

  • University of Alabama at Birmingham 1917 Research Clinic ( Site 5610)
  • Pueblo Family Physicians ( Site 5606)
  • Ruane Clinical Research Group, Inc. ( Site 5624)
  • Midway Immunology and Research ( Site 5622)
  • Floridian Clinical Research, LLC ( Site 5625)
  • The Kinder Medical Group ( Site 5615)
  • Orlando Immunology Center ( Site 5613)
  • CAN Community Health ( Site 5627)
  • Triple O Research Institute, P.A. ( Site 5621)
  • Columbus Regional Research Institute ( Site 5616)
  • Infectious Disease Specialists Of Atlanta PC ( Site 5608)
  • Hennepin Healthcare-Hennepin Healthcare-ID ( Site 5633)
  • Kansas City CARE Clinic ( Site 5607)
  • University of Pennsylvania ( Site 5630)
  • Saint Hope Foundation, Inc. ( Site 5629)
  • North Texas ID Consultants, PA ( Site 5604)
  • Texas Centers for Infectious Disease Associates P.A. ( Site 5619)
  • IDEAA Foundation ( Site 5807)
  • Fundación Huesped ( Site 5801)
  • Helios Salud S.A. ( Site 5802)
  • Instituto CAICI ( Site 5803)
  • Instituto Oulton ( Site 5804)
  • Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 5703)
  • Toronto General Hospital - University Health Network ( Site 5705)
  • Clinique Medicale L Actuel ( Site 5714)
  • McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 5702)
  • Hospital Dr. Hernan Henriquez Aravena ( Site 5905)
  • Clinica Universidad Catolica del Maule ( Site 5909)
  • Clinica Arauco Salud ( Site 5900)
  • Hospital Clinico de la Universidad Catolica ( Site 5903)
  • Fundacion Arriaran ( Site 5901)
  • Centro Cardiovascular Cardiosur ( Site 5907)
  • Hospital Universitario San Ignacio ( Site 6005)
  • Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 6006)
  • Fundacion Valle del Lili ( Site 6001)
  • A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 6124)
  • Centre Hospitalier Regional du Orleans ( Site 6108)
  • Hopital Francois Mitterrand ( Site 6119)
  • CHU de Bordeaux. Hopital Pellegrin ( Site 6116)
  • Centre Hospitalier de Tourcoing ( Site 6100)
  • Hopital de la Croix-Rousse ( Site 6127)
  • Hopital Avicenne ( Site 6102)
  • A.P.H. Paris, Hopital Saint Louis ( Site 6114)
  • Hopital Saint-Antoine ( Site 6113)
  • Hopital Pitie Salpetriere ( Site 6111)
  • Universitaetsklinik Freiburg ( Site 6206)
  • Klinikum der LMU München ( Site 6204)
  • MVZ Munchen am Goetheplatz ( Site 6202)
  • Infektiologikum ( Site 6201)
  • Universitaetsklinikum Bonn ( Site 6200)
  • EPIMED- Ges. f. epidemiolog. u. klin. Forschung in der Medizin mbH ( Site 6208)
  • Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 6210)
  • Rambam Medical Center ( Site 6701)
  • Hadassah Ein Kerem Medical Center ( Site 6702)
  • Chaim Sheba Medical Center. ( Site 6704)
  • Kaplan Medical Center ( Site 6700)
  • Sourasky Medical Center ( Site 6705)
  • A.O.R.N. dei Colli - Ospedale Cotugno ( Site 6407)
  • Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 6404)
  • ASST Papa Giovanni XXIII ( Site 6411)
  • Ospedale San Gerardo ASST Monza ( Site 6412)
  • Ospedale Amedeo di Savoia ( Site 6414)
  • Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 6401)
  • Salute San Raffaele ( Site 6402)
  • Azienda Ospedaliera San Paolo ( Site 6403)
  • ASST Fatebenefratelli-Ospedale Sacco ( Site 6400)
  • IRCCS Policlinico San Matteo ( Site 6410)
  • Azienda USL di Pescara-Presidio Ospedaliero di Pescara ( Site 6413)
  • Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 6405)
  • National Hospital Organization Nagoya Medical Center ( Site 6903)
  • Kumamoto University Hospital ( Site 6905)
  • National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 69
  • Tokyo Medical University Hospital ( Site 6904)
  • Center Hospital of the National Center for Global Health and Medicine ( Site 6901)
  • JOSHA Research ( Site 6605)
  • Chris Hani Baragwanath Hospital - ICU ( Site 6608)
  • Wits Health Consortium. Clinical HIV Research Unit ( Site 6614)
  • Ezintsha ( Site 6609)
  • Wentworth Hospital ( Site 6607)
  • Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6617)
  • Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 6613)
  • Be Part Yoluntu Centre ( Site 6603)
  • Hospital General de Elche ( Site 6308)
  • Hospital Universitari Germans Trias i Pujol ( Site 6301)
  • Hospital Universitari de Bellvitge ( Site 6312)
  • Hospital Vall D Hebron ( Site 6302)
  • Hospital Clinic i Provincial ( Site 6300)
  • Hospital General Universitario Gregorio Maranon ( Site 6303)
  • Hospital Universitario Fundacion Jimenez Diaz ( Site 6307)
  • Hospital Universitario 12 de Octubre ( Site 6305)
  • Hospital Universitario La Paz ( Site 6304)
  • Hospital Universitario Virgen de la Victoria ( Site 6309)
  • Kaohsiung Veterans General Hospital ( Site 7102)
  • National Cheng Kung University Hospital ( Site 7101)
  • National Taiwan University Hospital ( Site 7100)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1: DOR/ISL

Group 2: BIC/FTC/TAF

Arm Description

Treatment-naïve participants with HIV-1 receive blinded DOR/ISL and placebo to BIC/FTC/TAF once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. Participants who are benefitting from treatment are then eligible to continue on open-label DOR/ISL up to Week 168.

Treatment-naïve participants with HIV-1 receive blinded BIC/FTC/TAF and placebo to DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. Participants who are benefitting from treatment are then eligible to continue on open-label BIC/FTC/TAF up to Week 168.

Outcomes

Primary Outcome Measures

Percentage of participants with HIV-1 RNA <50 copies/mL
The percentage of participants with HIV-1 RNA <50 copies/mL 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.
Percentage of participants experiencing ≥1 adverse events (AEs)
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 interventions.
Percentage of participants discontinuing from study treatment due to AE(s)
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 interventions.

Secondary Outcome Measures

Percentage of participants with HIV-1 RNA <50 copies/mL
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.
Percentage of participants with HIV-1 RNA <50 copies/mL
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.
Percentage of participants with HIV-1 RNA <40 copies/mL
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.
Percentage of participants with HIV-1 RNA <200 copies/mL
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.
Percentage of participants with HIV-1 RNA <40 copies/mL
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.
Percentage of participants with HIV-1 RNA <200 copies/mL
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.
Percentage of participants with HIV-1 RNA <40 copies/mL
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.
Percentage of participants with HIV-1 RNA <200 copies/mL
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.
Change from baseline in cluster of differentiation 4+ (CD4+) T-cell counts
CD4+ T-cell counts will be measured by a central laboratory.
Change from baseline in cluster of differentiation 4+ (CD4+) T-cell counts
CD4+ T-cell counts will be measured by a central laboratory.
Change from baseline in cluster of differentiation 4+ (CD4+) T-cell counts
CD4+ T-cell counts will be measured by a central laboratory.
Incidence of viral resistance-associated substitutions (RASs)
The incidence of viral RASs will be determined.
Incidence of viral RASs
The incidence of viral RASs will be determined.
Incidence of viral RASs
The incidence of viral RASs will be determined.
Change from baseline in body weight
The change from baseline in participant body weight will be determined.
Change from baseline in body weight
The change from baseline in participant body weight will be determined.
Change from baseline in body weight
The change from baseline in participant body weight will be determined.
Percentage of participants experiencing ≥1 adverse events (AEs)
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 interventions.
Percentage of participants discontinuing from study treatment due to AE(s)
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 interventions.

Full Information

First Posted
January 15, 2020
Last Updated
November 28, 2022
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04233879
Brief Title
Randomized, Double-blind, Efficacy, and Safety Study of Doravirine/Islatravir (DOR/ISL) in Treatment-naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)
Official Title
A Phase 3 Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir Once-Daily in HIV-1 Infected Treatment-Naïve Participants
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
November 17, 2022 (Actual)
Study Completion Date
March 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL [also known as MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type-1 (HIV-1) infection. The primary objectives are to evaluate the antiretroviral activity, safety, and tolerability of DOR/ISL compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that DOR/ISL is noninferior or superior to BIC/FTC/TAF treatment based on the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.
Detailed Description
Double-blind treatment with the assigned intervention occurs from Day 1 to Week 96, followed by an open-label portion up to Week 144. Participants who benefit from treatment in the opinion of the Investigator may continue their assigned intervention up to Week 168 (or until they have the option to enroll in a DOR/ISL 100 mg/0.25 mg study, whichever is sooner).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
599 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: DOR/ISL
Arm Type
Experimental
Arm Description
Treatment-naïve participants with HIV-1 receive blinded DOR/ISL and placebo to BIC/FTC/TAF once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. Participants who are benefitting from treatment are then eligible to continue on open-label DOR/ISL up to Week 168.
Arm Title
Group 2: BIC/FTC/TAF
Arm Type
Active Comparator
Arm Description
Treatment-naïve participants with HIV-1 receive blinded BIC/FTC/TAF and placebo to DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. Participants who are benefitting from treatment are then eligible to continue on open-label BIC/FTC/TAF up to Week 168.
Intervention Type
Drug
Intervention Name(s)
DOR/ISL
Other Intervention Name(s)
MK-8591A, Doravirine/islatravir
Intervention Description
100 mg DOR/0.75 mg ISL FDC tablet taken once daily by mouth.
Intervention Type
Drug
Intervention Name(s)
BIC/FTC/TAF
Other Intervention Name(s)
Bictegravir/emtricitabine/tenofovir alafenamide
Intervention Description
BIC/FTC/TAF 50/200/25 mg FDC tablet taken once daily by mouth.
Intervention Type
Drug
Intervention Name(s)
Placebo to BIC/FTC/TAF
Intervention Description
Placebo tablet matched to BIC/FTC/TAF taken by mouth.
Intervention Type
Drug
Intervention Name(s)
Placebo to DOR/ISL
Intervention Description
Placebo tablet matched to DOR/ISL taken by mouth.
Primary Outcome Measure Information:
Title
Percentage of participants with HIV-1 RNA <50 copies/mL
Description
The percentage of participants with HIV-1 RNA <50 copies/mL 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.
Time Frame
Week 48
Title
Percentage of participants experiencing ≥1 adverse events (AEs)
Description
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 interventions.
Time Frame
Up to 48 weeks
Title
Percentage of participants discontinuing from study treatment due to AE(s)
Description
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 interventions.
Time Frame
Up to 48 weeks
Secondary Outcome Measure Information:
Title
Percentage of participants with HIV-1 RNA <50 copies/mL
Description
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.
Time Frame
Week 96
Title
Percentage of participants with HIV-1 RNA <50 copies/mL
Description
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.
Time Frame
Week 144
Title
Percentage of participants with HIV-1 RNA <40 copies/mL
Description
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.
Time Frame
Week 48
Title
Percentage of participants with HIV-1 RNA <200 copies/mL
Description
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.
Time Frame
Week 48
Title
Percentage of participants with HIV-1 RNA <40 copies/mL
Description
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.
Time Frame
Week 96
Title
Percentage of participants with HIV-1 RNA <200 copies/mL
Description
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.
Time Frame
Week 96
Title
Percentage of participants with HIV-1 RNA <40 copies/mL
Description
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.
Time Frame
Week 144
Title
Percentage of participants with HIV-1 RNA <200 copies/mL
Description
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.
Time Frame
Week 144
Title
Change from baseline in cluster of differentiation 4+ (CD4+) T-cell counts
Description
CD4+ T-cell counts will be measured by a central laboratory.
Time Frame
Day 1 (baseline) and Week 48
Title
Change from baseline in cluster of differentiation 4+ (CD4+) T-cell counts
Description
CD4+ T-cell counts will be measured by a central laboratory.
Time Frame
Day 1 (baseline) and Week 96
Title
Change from baseline in cluster of differentiation 4+ (CD4+) T-cell counts
Description
CD4+ T-cell counts will be measured by a central laboratory.
Time Frame
Day 1 (baseline) and Week 144
Title
Incidence of viral resistance-associated substitutions (RASs)
Description
The incidence of viral RASs will be determined.
Time Frame
Week 48
Title
Incidence of viral RASs
Description
The incidence of viral RASs will be determined.
Time Frame
Week 96
Title
Incidence of viral RASs
Description
The incidence of viral RASs will be determined.
Time Frame
Week 144
Title
Change from baseline in body weight
Description
The change from baseline in participant body weight will be determined.
Time Frame
Day 1 (baseline) and Week 48
Title
Change from baseline in body weight
Description
The change from baseline in participant body weight will be determined.
Time Frame
Day 1 (baseline) and Week 96
Title
Change from baseline in body weight
Description
The change from baseline in participant body weight will be determined.
Time Frame
Day 1 (baseline) and Week 144
Title
Percentage of participants experiencing ≥1 adverse events (AEs)
Description
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 interventions.
Time Frame
Up to 156 weeks
Title
Percentage of participants discontinuing from study treatment due to AE(s)
Description
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 interventions.
Time Frame
Up to 144 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is HIV-1 positive Is naïve to antiretroviral therapy (ART) defined as having received ≤10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection including prevention of mother-to-child transmission up to 1 month prior to screening. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); 2) Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis); 3) 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; 4) If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required 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 HBV infection (defined as hepatitis B surface antigen [HBsAg]-positive or hepatitis B virus deoxyribonucleic acid [HBV DNA]-positive) 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 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 Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1 Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapy from 45 days prior to Day 1 through the study intervention period 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 intervention period Has a documented or known virologic resistance to any approved HIV-1 reverse transcriptase inhibitor, or any study intervention Has exclusionary laboratory values within 45 days prior to Day 1 Is female and is expecting to conceive or donate eggs at any time during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham 1917 Research Clinic ( Site 5610)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35222
Country
United States
Facility Name
Pueblo Family Physicians ( Site 5606)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Ruane Clinical Research Group, Inc. ( Site 5624)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Midway Immunology and Research ( Site 5622)
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
Floridian Clinical Research, LLC ( Site 5625)
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
The Kinder Medical Group ( Site 5615)
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Orlando Immunology Center ( Site 5613)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
CAN Community Health ( Site 5627)
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34237
Country
United States
Facility Name
Triple O Research Institute, P.A. ( Site 5621)
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Columbus Regional Research Institute ( Site 5616)
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Infectious Disease Specialists Of Atlanta PC ( Site 5608)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Hennepin Healthcare-Hennepin Healthcare-ID ( Site 5633)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Kansas City CARE Clinic ( Site 5607)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
University of Pennsylvania ( Site 5630)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Saint Hope Foundation, Inc. ( Site 5629)
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
North Texas ID Consultants, PA ( Site 5604)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Centers for Infectious Disease Associates P.A. ( Site 5619)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
IDEAA Foundation ( Site 5807)
City
Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1405CKC
Country
Argentina
Facility Name
Fundación Huesped ( Site 5801)
City
C.a.b.a
State/Province
Caba
ZIP/Postal Code
C1202ABB
Country
Argentina
Facility Name
Helios Salud S.A. ( Site 5802)
City
Ciudad Autonoma de Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1141ACG
Country
Argentina
Facility Name
Instituto CAICI ( Site 5803)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000PBJ
Country
Argentina
Facility Name
Instituto Oulton ( Site 5804)
City
Cordoba
ZIP/Postal Code
X5000JJS
Country
Argentina
Facility Name
Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 5703)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 14K
Country
Canada
Facility Name
Toronto General Hospital - University Health Network ( Site 5705)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Clinique Medicale L Actuel ( Site 5714)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4P9
Country
Canada
Facility Name
McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 5702)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Hospital Dr. Hernan Henriquez Aravena ( Site 5905)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4781151
Country
Chile
Facility Name
Clinica Universidad Catolica del Maule ( Site 5909)
City
Talca
State/Province
Maule
ZIP/Postal Code
3460000
Country
Chile
Facility Name
Clinica Arauco Salud ( Site 5900)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7560994
Country
Chile
Facility Name
Hospital Clinico de la Universidad Catolica ( Site 5903)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8331150
Country
Chile
Facility Name
Fundacion Arriaran ( Site 5901)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8360159
Country
Chile
Facility Name
Centro Cardiovascular Cardiosur ( Site 5907)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8910259
Country
Chile
Facility Name
Hospital Universitario San Ignacio ( Site 6005)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110231
Country
Colombia
Facility Name
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 6006)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
111321
Country
Colombia
Facility Name
Fundacion Valle del Lili ( Site 6001)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Facility Name
A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 6124)
City
Paris
State/Province
Ain
ZIP/Postal Code
75018
Country
France
Facility Name
Centre Hospitalier Regional du Orleans ( Site 6108)
City
Orleans
State/Province
Centre
ZIP/Postal Code
45000
Country
France
Facility Name
Hopital Francois Mitterrand ( Site 6119)
City
Dijon
State/Province
Cote-d Or
ZIP/Postal Code
21079
Country
France
Facility Name
CHU de Bordeaux. Hopital Pellegrin ( Site 6116)
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Hospitalier de Tourcoing ( Site 6100)
City
Tourcoing
State/Province
Nord
ZIP/Postal Code
59208
Country
France
Facility Name
Hopital de la Croix-Rousse ( Site 6127)
City
Lyon
State/Province
Rhone-Alpes
ZIP/Postal Code
69004
Country
France
Facility Name
Hopital Avicenne ( Site 6102)
City
Bobigny
State/Province
Seine-Saint-Denis
ZIP/Postal Code
93000
Country
France
Facility Name
A.P.H. Paris, Hopital Saint Louis ( Site 6114)
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Saint-Antoine ( Site 6113)
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital Pitie Salpetriere ( Site 6111)
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Universitaetsklinik Freiburg ( Site 6206)
City
Freiburg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Klinikum der LMU München ( Site 6204)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
Facility Name
MVZ Munchen am Goetheplatz ( Site 6202)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80337
Country
Germany
Facility Name
Infektiologikum ( Site 6201)
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Facility Name
Universitaetsklinikum Bonn ( Site 6200)
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53127
Country
Germany
Facility Name
EPIMED- Ges. f. epidemiolog. u. klin. Forschung in der Medizin mbH ( Site 6208)
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 6210)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Rambam Medical Center ( Site 6701)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah Ein Kerem Medical Center ( Site 6702)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Chaim Sheba Medical Center. ( Site 6704)
City
Ramat-Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Kaplan Medical Center ( Site 6700)
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Sourasky Medical Center ( Site 6705)
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
A.O.R.N. dei Colli - Ospedale Cotugno ( Site 6407)
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 6404)
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41124
Country
Italy
Facility Name
ASST Papa Giovanni XXIII ( Site 6411)
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Facility Name
Ospedale San Gerardo ASST Monza ( Site 6412)
City
Monza
State/Province
Monza E Brianza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Ospedale Amedeo di Savoia ( Site 6414)
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10149
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 6401)
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Salute San Raffaele ( Site 6402)
City
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
Azienda Ospedaliera San Paolo ( Site 6403)
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
ASST Fatebenefratelli-Ospedale Sacco ( Site 6400)
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
IRCCS Policlinico San Matteo ( Site 6410)
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda USL di Pescara-Presidio Ospedaliero di Pescara ( Site 6413)
City
Pescara
ZIP/Postal Code
65129
Country
Italy
Facility Name
Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 6405)
City
Roma
ZIP/Postal Code
00149
Country
Italy
Facility Name
National Hospital Organization Nagoya Medical Center ( Site 6903)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Kumamoto University Hospital ( Site 6905)
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 69
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Tokyo Medical University Hospital ( Site 6904)
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine ( Site 6901)
City
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
JOSHA Research ( Site 6605)
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Chris Hani Baragwanath Hospital - ICU ( Site 6608)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1862
Country
South Africa
Facility Name
Wits Health Consortium. Clinical HIV Research Unit ( Site 6614)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2041
Country
South Africa
Facility Name
Ezintsha ( Site 6609)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Wentworth Hospital ( Site 6607)
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4052
Country
South Africa
Facility Name
Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6617)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 6613)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Be Part Yoluntu Centre ( Site 6603)
City
Mbekweni, Paarl
State/Province
Western Cape
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Hospital General de Elche ( Site 6308)
City
Elche
State/Province
Alicante
ZIP/Postal Code
03202
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol ( Site 6301)
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitari de Bellvitge ( Site 6312)
City
LHospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Vall D Hebron ( Site 6302)
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial ( Site 6300)
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon ( Site 6303)
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz ( Site 6307)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre ( Site 6305)
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz ( Site 6304)
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria ( Site 6309)
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Kaohsiung Veterans General Hospital ( Site 7102)
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
National Cheng Kung University Hospital ( Site 7101)
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 7100)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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

Learn more about this trial

Randomized, Double-blind, Efficacy, and Safety Study of Doravirine/Islatravir (DOR/ISL) in Treatment-naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)

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