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

Primary Purpose

HIV-1 Infection

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ISL
DOR
DOR/ISL
Placebo to ISL
Placebo to DOR
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

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

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.

Sites / Locations

  • University of Alabama at Birmingham 1917 Research Clinic ( Site 4031)
  • Men's Health Foundation ( Site 4018)
  • Palmtree Clinical Research, Inc. ( Site 4016)
  • Yale School of Medicine ( Site 4007)
  • Georgetown University Hospital ( Site 4015)
  • The Kinder Medical Group ( Site 4014)
  • Orlando Immunology Center ( Site 4012)
  • Triple O Research Institute, P.A. ( Site 4020)
  • Chatham County Health Department ( Site 4029)
  • Howard Brown Health Center ( Site 4006)
  • Northstar Healthcare ( Site 4004)
  • University of Maryland ( Site 4023)
  • The University of Mississippi Medical Center ( Site 4036)
  • Saint Michael's Medical Center-Research - Infectious Disease ( Site 4035)
  • Icahn School of Medicine at Mount Sinai ( Site 4000)
  • University of North Carolina at Chapel Hill ( Site 4026)
  • Saint Hope Foundation, Inc. ( Site 4034)
  • North Texas Infectious Diseases Consultants, PA ( Site 4005)
  • Dr. Peter Shalit, MD ( Site 4002)
  • Holdsworth House Medical Practice ( Site 5300)
  • St Vincent's Hospital ( Site 5309)
  • Holdsworth House Medical Practice - Brisbane ( Site 5312)
  • Monash Health-Monash Medical Centre ( Site 5313)
  • The Alfred Hospital ( Site 5304)
  • Vancouver ID Research and Care Centre Society ( Site 4100)
  • Hamilton Health Sciences ( Site 4115)
  • Ottawa Hospital Research Institute ( Site 4111)
  • Toronto General Hospital - University Health Network ( Site 4105)
  • McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 4102)
  • Hospital Dr. Hernan Henriquez Aravena ( Site 4405)
  • Fundacion Arriaran ( Site 4401)
  • Centro Cardiovascular Cardiosur ( Site 4407)
  • Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 4306)
  • Fundacion Valle del Lili ( Site 4301)
  • Hopital Edouard Herriot ( Site 4726)
  • A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 4724)
  • CHU de Nice Hopital Archet 1 ( Site 4703)
  • Hopital Europeen Marseille ( Site 4717)
  • CHU de Bordeaux- Hopital Saint Andre ( Site 4715)
  • CHU de Rouen ( Site 4705)
  • CHU de Montpellier - Hopital Saint-Eloi ( Site 4721)
  • Centre Hospitalier de Tourcoing ( Site 4700)
  • Hopital Avicenne ( Site 4702)
  • Hopital Hotel Dieu [Paris, France] ( Site 4723)
  • A.P.H. Paris, Hopital Saint Louis ( Site 4714)
  • Medizinische Hochschule Hannover ( Site 4612)
  • Universitaetsklinikum Bonn ( Site 4600)
  • Universitaetsklinikum Essen ( Site 4607)
  • ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 4603)
  • EPIMED GmbH ( Site 4608)
  • ICH Study Center GmbH & Co.KG ( Site 4609)
  • Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 5004)
  • Ospedale San Gerardo ASST Monza ( Site 5012)
  • Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 5001)
  • Universita' Vita Salute. Ospedale San Raffaele ( Site 5002)
  • Azienda Ospedaliera San Paolo ( Site 5003)
  • ASST Fatebenefratelli-Ospedale Sacco ( Site 5000)
  • IRCCS Policlinico San Matteo ( Site 5010)
  • Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 5005)
  • Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 5006)
  • Center Hospital of the National Center for Global Health and Medicine ( Site 5401)
  • Pusan National University Hospital ( Site 5503)
  • Severance Hospital Yonsei University Health System ( Site 5500)
  • The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 5502)
  • INMENSA ( Site 4506)
  • Via Libre ( Site 4500)
  • Policlinico Universidad Nacional Mayor de San Marcos ( Site 4501)
  • Hospital de Nossa Senhora da Oliveira- EPE ( Site 4905)
  • Hospital Dr. Fernando Fonseca, EPE - Amadora/Sintra ( Site 4902)
  • Centro Hospitalar de Lisboa Norte Hospital de Santa Maria ( Site 4913)
  • Hospital Geral de Santo Antonio ( Site 4908)
  • Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 4907)
  • HOPE Clinical Research ( Site 5700)
  • Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 5101)
  • Infectious Clinical Hospital #2 ( Site 5114)
  • Gbuz Samarskiy Oblastnoy Klinicheskiy Tsentr Profilaktiki I Bor'by So Spid ( Site 5113)
  • FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 5100)
  • Smolensk Center On Aids And Infectious Diseases Prophylaxis ( Site 5115)
  • Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 5106)
  • Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 5104)
  • FARMOVS ( Site 4805)
  • Wits Clinical HIV Research Unit ( Site 4804)
  • Ezintsha ( Site 4806)
  • King Edward Hospital ( Site 4802)
  • Hospital Universitari Germans Trias i Pujol ( Site 5600)
  • Hospital Clinic i Provincial ( Site 5601)
  • Hospital Santa Lucia ( Site 5603)
  • Hospital Universitario La Paz ( Site 5604)
  • Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 5619)
  • Regional Clinical Infectious Hospital ( Site 5614)
  • Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 5620)
  • Institute of Epidemiology and Infect Diseases of the NAMS of Ukraine ( Site 5615)
  • Mykolaiv center of paliative assistance and integrated services ( Site 5621)
  • MNE Odesa Regional Center of Socially Significant Diseases ( Site 5611)
  • MI Vinnytsia Regional Center of AIDS Prevention and Care ( Site 5618)
  • Kyiv City Clinical Hospital 5 ( Site 5616)
  • Royal Free Hospital ( Site 5202)
  • Western General Hospital ( Site 5201)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

ISL + ART

DOR + ART

DOR/ISL + ART

Placebo + ART

Arm Description

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; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97.

HTE participants with HIV-1 infection take DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.

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; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.

HTE participants with HIV-1 infection take placebo QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.

Outcomes

Primary Outcome Measures

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
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.
Percentage of participants with ≥1 adverse events (AEs)
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.
Percentage of participants withdrawing from study treatment due to AE(s)
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

Percentage of participants with ≥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 intervention.
Percentage of participants discontinuing from study therapy 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 intervention.
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
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.
Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART), DOR, or ISL compared to placebo treatment
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.
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
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.
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
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.
Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) compared to DOR or ISL treatment
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT
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.
Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT
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.
Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT
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.
Percentage of participants receiving DOR/ISL (given with ART) + OBT 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 receiving DOR/ISL (given with ART) + OBT 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 receiving DOR/ISL (given with ART) + OBT 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 receiving DOR/ISL (given with ART) + OBT 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 receiving DOR/ISL (given with ART) + OBT 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 receiving DOR/ISL (given with ART) + OBT 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 receiving DOR/ISL (given with ART) + OBT 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 receiving DOR/ISL (given with ART) + OBT 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 receiving DOR/ISL (given with ART) + OBT 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.
Prevalence of viral drug resistance to DOR
The prevalence of viral drug resistance to DOR will be determined. Viral resistance testing will be performed by the central laboratory.
Prevalence of viral drug resistance to DOR
The prevalence of viral drug resistance to DOR will be determined. Viral resistance testing will be performed by the central laboratory.
Prevalence of viral drug resistance to ISL
The prevalence of viral drug resistance to ISL will be determined. Viral resistance testing will be performed by the central laboratory.
Prevalence of viral drug resistance to ISL
The prevalence of viral drug resistance to ISL will be determined. Viral resistance testing will be performed by the central laboratory.
Prevalence of viral drug resistance to optimized background therapy (OBT) components
The prevalence of viral drug resistance to OBT components will be determined. Viral resistance testing will be performed by the central laboratory.
Prevalence of viral drug resistance to OBT components
The prevalence of viral drug resistance to OBT components will be determined. Viral resistance testing will be performed by the central laboratory.
Role of baseline antiviral resistance on viral resistance-associated substitutions (RASs)
The role of baseline antiviral resistance on viral RAS will be determined.
Role of baseline antiviral resistance on viral RASs
The role of baseline antiviral resistance on viral RAS will be determined.
Role of baseline antiviral resistance on viral RASs
The role of baseline antiviral resistance on viral RAS will be determined.
Role of baseline antiviral resistance on HIV-1 RNA
The role of baseline antiviral resistance on HIV-1 RNA will be determined.
Role of baseline antiviral resistance on HIV-1 RNA
The role of baseline antiviral resistance on HIV-1 RNA will be determined.
Role of baseline antiviral resistance on HIV-1 RNA
The role of baseline antiviral resistance on HIV-1 RNA will be determined.
Change from baseline in cluster of differentiation 4+ (CD4+) T-cell counts
The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
Change from baseline in CD4+ T-cell counts
The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
Change from baseline in CD4+ T-cell counts
The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
Change from baseline in CD4+ T-cell counts
The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
Change from baseline in CD4+ T-cell counts
The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
Change from baseline in CD4+ T-cell counts
The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.

Full Information

First Posted
January 15, 2020
Last Updated
September 28, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04233216
Brief Title
Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 18, 2020 (Actual)
Primary Completion Date
November 21, 2022 (Actual)
Study Completion Date
November 8, 2023 (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 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).
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).

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
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ISL + ART
Arm Type
Experimental
Arm Description
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; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97.
Arm Title
DOR + ART
Arm Type
Experimental
Arm Description
HTE participants with HIV-1 infection take DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.
Arm Title
DOR/ISL + ART
Arm Type
Experimental
Arm Description
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; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.
Arm Title
Placebo + ART
Arm Type
Placebo Comparator
Arm Description
HTE participants with HIV-1 infection take placebo QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.
Intervention Type
Drug
Intervention Name(s)
ISL
Other Intervention Name(s)
Islatravir, MK-8591
Intervention Description
ISL 0.75 mg capsule taken by mouth.
Intervention Type
Drug
Intervention Name(s)
DOR
Other Intervention Name(s)
Doravirine, MK-1439
Intervention Description
DOR 100 mg tablet taken by mouth.
Intervention Type
Drug
Intervention Name(s)
DOR/ISL
Other Intervention Name(s)
Doravirine/Islatravir, MK-8591A
Intervention Description
100 mg DOR/0.75 mg ISL FDC taken by mouth.
Intervention Type
Drug
Intervention Name(s)
Placebo to ISL
Intervention Description
Placebo capsule matched to ISL taken by mouth.
Intervention Type
Drug
Intervention Name(s)
Placebo to DOR
Intervention Description
Placebo tablet matched to DOR taken by mouth.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Day 1 (baseline) and Day 8
Title
Percentage of participants with ≥1 adverse events (AEs)
Description
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.
Time Frame
Up to 49 weeks
Title
Percentage of participants withdrawing from study treatment due to AE(s)
Description
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.
Time Frame
Up to 49 weeks
Secondary Outcome Measure Information:
Title
Percentage of participants with ≥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 intervention.
Time Frame
Up to 97 weeks
Title
Percentage of participants discontinuing from study therapy 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 intervention.
Time Frame
Up to 97 weeks
Title
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
Description
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.
Time Frame
Day 1 (baseline) and Day 8
Title
Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART), DOR, or ISL compared to placebo treatment
Description
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.
Time Frame
Day 1 (baseline) and Day 8
Title
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
Description
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.
Time Frame
Day 1 (baseline) and Day 8
Title
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
Description
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.
Time Frame
Day 1 (baseline) and Day 8
Title
Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) compared to DOR or ISL treatment
Description
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.
Time Frame
Day 1 (baseline) and Day 8
Title
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
Description
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.
Time Frame
Day 1 (baseline) and Day 8
Title
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
Description
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.
Time Frame
Day 8 (baseline) and Week 25
Title
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
Description
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.
Time Frame
Day 1 (baseline) and Week 49
Title
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
Description
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.
Time Frame
Day 1 (baseline) and Week 97
Title
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
Description
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.
Time Frame
Day 8 (baseline) and Week 25
Title
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
Description
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.
Time Frame
Day 1 (baseline) and Week 49
Title
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
Description
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.
Time Frame
Day 1 (baseline) and Week 97
Title
Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT
Description
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.
Time Frame
Day 8 (baseline) and Week 25
Title
Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT
Description
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.
Time Frame
Day 1 (baseline) and Week 49
Title
Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT
Description
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.
Time Frame
Day 8 (baseline) and Week 97
Title
Percentage of participants receiving DOR/ISL (given with ART) + OBT 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
Day 8 (baseline) and Week 25
Title
Percentage of participants receiving DOR/ISL (given with ART) + OBT 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
Day 1 (baseline) and Week 49
Title
Percentage of participants receiving DOR/ISL (given with ART) + OBT 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
Day 1 (baseline) and Week 97
Title
Percentage of participants receiving DOR/ISL (given with ART) + OBT 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
Day 8 (baseline) and Week 25
Title
Percentage of participants receiving DOR/ISL (given with ART) + OBT 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
Day 1 (baseline) and Week 49
Title
Percentage of participants receiving DOR/ISL (given with ART) + OBT 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
Day 1 (baseline) and Week 97
Title
Percentage of participants receiving DOR/ISL (given with ART) + OBT 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
Day 8 (baseline) and Week 25
Title
Percentage of participants receiving DOR/ISL (given with ART) + OBT 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
Day 1 (baseline) and Week 49
Title
Percentage of participants receiving DOR/ISL (given with ART) + OBT 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
Day 1 (baseline) and Week 97
Title
Prevalence of viral drug resistance to DOR
Description
The prevalence of viral drug resistance to DOR will be determined. Viral resistance testing will be performed by the central laboratory.
Time Frame
Week 25
Title
Prevalence of viral drug resistance to DOR
Description
The prevalence of viral drug resistance to DOR will be determined. Viral resistance testing will be performed by the central laboratory.
Time Frame
Week 49
Title
Prevalence of viral drug resistance to ISL
Description
The prevalence of viral drug resistance to ISL will be determined. Viral resistance testing will be performed by the central laboratory.
Time Frame
Week 25
Title
Prevalence of viral drug resistance to ISL
Description
The prevalence of viral drug resistance to ISL will be determined. Viral resistance testing will be performed by the central laboratory.
Time Frame
Week 49
Title
Prevalence of viral drug resistance to optimized background therapy (OBT) components
Description
The prevalence of viral drug resistance to OBT components will be determined. Viral resistance testing will be performed by the central laboratory.
Time Frame
Week 25
Title
Prevalence of viral drug resistance to OBT components
Description
The prevalence of viral drug resistance to OBT components will be determined. Viral resistance testing will be performed by the central laboratory.
Time Frame
Week 49
Title
Role of baseline antiviral resistance on viral resistance-associated substitutions (RASs)
Description
The role of baseline antiviral resistance on viral RAS will be determined.
Time Frame
Day 1 (baseline) and Week 25
Title
Role of baseline antiviral resistance on viral RASs
Description
The role of baseline antiviral resistance on viral RAS will be determined.
Time Frame
Day 1 (baseline) and Week 49
Title
Role of baseline antiviral resistance on viral RASs
Description
The role of baseline antiviral resistance on viral RAS will be determined.
Time Frame
Day 1 (baseline) and Week 97
Title
Role of baseline antiviral resistance on HIV-1 RNA
Description
The role of baseline antiviral resistance on HIV-1 RNA will be determined.
Time Frame
Day 8 (baseline) and Week 25
Title
Role of baseline antiviral resistance on HIV-1 RNA
Description
The role of baseline antiviral resistance on HIV-1 RNA will be determined.
Time Frame
Day 8 (baseline) and Week 49
Title
Role of baseline antiviral resistance on HIV-1 RNA
Description
The role of baseline antiviral resistance on HIV-1 RNA will be determined.
Time Frame
Day 8 (baseline) and Week 97
Title
Change from baseline in cluster of differentiation 4+ (CD4+) T-cell counts
Description
The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
Time Frame
Day 1 (baseline) and Week 25
Title
Change from baseline in CD4+ T-cell counts
Description
The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
Time Frame
Day 1 (baseline) and Week 49
Title
Change from baseline in CD4+ T-cell counts
Description
The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
Time Frame
Day 1 (baseline) and Week 97
Title
Change from baseline in CD4+ T-cell counts
Description
The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
Time Frame
Day 8 (baseline) and Week 25
Title
Change from baseline in CD4+ T-cell counts
Description
The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
Time Frame
Day 8 (baseline) and Week 49
Title
Change from baseline in CD4+ T-cell counts
Description
The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
Time Frame
Day 8 (baseline) and Week 97

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
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 4031)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35222
Country
United States
Facility Name
Men's Health Foundation ( Site 4018)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Palmtree Clinical Research, Inc. ( Site 4016)
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Yale School of Medicine ( Site 4007)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Georgetown University Hospital ( Site 4015)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
The Kinder Medical Group ( Site 4014)
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Orlando Immunology Center ( Site 4012)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Triple O Research Institute, P.A. ( Site 4020)
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Chatham County Health Department ( Site 4029)
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31410
Country
United States
Facility Name
Howard Brown Health Center ( Site 4006)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60613
Country
United States
Facility Name
Northstar Healthcare ( Site 4004)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
University of Maryland ( Site 4023)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
The University of Mississippi Medical Center ( Site 4036)
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Saint Michael's Medical Center-Research - Infectious Disease ( Site 4035)
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai ( Site 4000)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina at Chapel Hill ( Site 4026)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Saint Hope Foundation, Inc. ( Site 4034)
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
North Texas Infectious Diseases Consultants, PA ( Site 4005)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Dr. Peter Shalit, MD ( Site 4002)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Holdsworth House Medical Practice ( Site 5300)
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
St Vincent's Hospital ( Site 5309)
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Holdsworth House Medical Practice - Brisbane ( Site 5312)
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
Monash Health-Monash Medical Centre ( Site 5313)
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
The Alfred Hospital ( Site 5304)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Vancouver ID Research and Care Centre Society ( Site 4100)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2C7
Country
Canada
Facility Name
Hamilton Health Sciences ( Site 4115)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Ottawa Hospital Research Institute ( Site 4111)
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Toronto General Hospital - University Health Network ( Site 4105)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 4102)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Hospital Dr. Hernan Henriquez Aravena ( Site 4405)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4781151
Country
Chile
Facility Name
Fundacion Arriaran ( Site 4401)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8360159
Country
Chile
Facility Name
Centro Cardiovascular Cardiosur ( Site 4407)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8910259
Country
Chile
Facility Name
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 4306)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
111321
Country
Colombia
Facility Name
Fundacion Valle del Lili ( Site 4301)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Facility Name
Hopital Edouard Herriot ( Site 4726)
City
Lyon
State/Province
Ain
ZIP/Postal Code
69003
Country
France
Facility Name
A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 4724)
City
Paris
State/Province
Ain
ZIP/Postal Code
75018
Country
France
Facility Name
CHU de Nice Hopital Archet 1 ( Site 4703)
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Europeen Marseille ( Site 4717)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13003
Country
France
Facility Name
CHU de Bordeaux- Hopital Saint Andre ( Site 4715)
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33075
Country
France
Facility Name
CHU de Rouen ( Site 4705)
City
Rouen
State/Province
Haute-Normandie
ZIP/Postal Code
76031
Country
France
Facility Name
CHU de Montpellier - Hopital Saint-Eloi ( Site 4721)
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Hospitalier de Tourcoing ( Site 4700)
City
Tourcoing
State/Province
Nord
ZIP/Postal Code
59208
Country
France
Facility Name
Hopital Avicenne ( Site 4702)
City
Bobigny
State/Province
Seine-Saint-Denis
ZIP/Postal Code
93000
Country
France
Facility Name
Hopital Hotel Dieu [Paris, France] ( Site 4723)
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Name
A.P.H. Paris, Hopital Saint Louis ( Site 4714)
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Medizinische Hochschule Hannover ( Site 4612)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Bonn ( Site 4600)
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitaetsklinikum Essen ( Site 4607)
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Name
ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 4603)
City
Berlin
ZIP/Postal Code
10439
Country
Germany
Facility Name
EPIMED GmbH ( Site 4608)
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
ICH Study Center GmbH & Co.KG ( Site 4609)
City
Hamburg
ZIP/Postal Code
20146
Country
Germany
Facility Name
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 5004)
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41124
Country
Italy
Facility Name
Ospedale San Gerardo ASST Monza ( Site 5012)
City
Monza
State/Province
Monza E Brianza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 5001)
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Universita' Vita Salute. Ospedale San Raffaele ( Site 5002)
City
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
Azienda Ospedaliera San Paolo ( Site 5003)
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
ASST Fatebenefratelli-Ospedale Sacco ( Site 5000)
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
IRCCS Policlinico San Matteo ( Site 5010)
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 5005)
City
Roma
ZIP/Postal Code
00149
Country
Italy
Facility Name
Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 5006)
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Center Hospital of the National Center for Global Health and Medicine ( Site 5401)
City
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Pusan National University Hospital ( Site 5503)
City
Busan
State/Province
Pusan-Kwangyokshi
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 5500)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 5502)
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
INMENSA ( Site 4506)
City
Lima
State/Province
Muni Metro De Lima
ZIP/Postal Code
15046
Country
Peru
Facility Name
Via Libre ( Site 4500)
City
Lima
ZIP/Postal Code
15001
Country
Peru
Facility Name
Policlinico Universidad Nacional Mayor de San Marcos ( Site 4501)
City
Lima
ZIP/Postal Code
15081
Country
Peru
Facility Name
Hospital de Nossa Senhora da Oliveira- EPE ( Site 4905)
City
Guimaraes
State/Province
Braga
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Hospital Dr. Fernando Fonseca, EPE - Amadora/Sintra ( Site 4902)
City
Amadora
State/Province
Lisboa
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Norte Hospital de Santa Maria ( Site 4913)
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital Geral de Santo Antonio ( Site 4908)
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 4907)
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
HOPE Clinical Research ( Site 5700)
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 5101)
City
Saint Petersburg
State/Province
Leningradskaya Oblast
Country
Russian Federation
Facility Name
Infectious Clinical Hospital #2 ( Site 5114)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
105275
Country
Russian Federation
Facility Name
Gbuz Samarskiy Oblastnoy Klinicheskiy Tsentr Profilaktiki I Bor'by So Spid ( Site 5113)
City
Samara
State/Province
Samarskaya Oblast
ZIP/Postal Code
443124
Country
Russian Federation
Facility Name
FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 5100)
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
196645
Country
Russian Federation
Facility Name
Smolensk Center On Aids And Infectious Diseases Prophylaxis ( Site 5115)
City
Smolensk
State/Province
Smolenskaya Oblast
ZIP/Postal Code
214006
Country
Russian Federation
Facility Name
Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 5106)
City
Yekaterinburg
State/Province
Sverdlovskaya Oblast
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 5104)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420140
Country
Russian Federation
Facility Name
FARMOVS ( Site 4805)
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Wits Clinical HIV Research Unit ( Site 4804)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2041
Country
South Africa
Facility Name
Ezintsha ( Site 4806)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
King Edward Hospital ( Site 4802)
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4013
Country
South Africa
Facility Name
Hospital Universitari Germans Trias i Pujol ( Site 5600)
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Clinic i Provincial ( Site 5601)
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Santa Lucia ( Site 5603)
City
Cartagena
State/Province
Murcia, Region De
ZIP/Postal Code
30202
Country
Spain
Facility Name
Hospital Universitario La Paz ( Site 5604)
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 5619)
City
Dnipro
State/Province
Dnipropetrovska Oblast
ZIP/Postal Code
49115
Country
Ukraine
Facility Name
Regional Clinical Infectious Hospital ( Site 5614)
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61096
Country
Ukraine
Facility Name
Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 5620)
City
Kherson
State/Province
Khersonska Oblast
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Institute of Epidemiology and Infect Diseases of the NAMS of Ukraine ( Site 5615)
City
Kyiv
State/Province
Kyivska Oblast
ZIP/Postal Code
03038
Country
Ukraine
Facility Name
Mykolaiv center of paliative assistance and integrated services ( Site 5621)
City
Mykolaiv
State/Province
Mykolaivska Oblast
ZIP/Postal Code
54003
Country
Ukraine
Facility Name
MNE Odesa Regional Center of Socially Significant Diseases ( Site 5611)
City
Odesa
State/Province
Odeska Oblast
ZIP/Postal Code
65014
Country
Ukraine
Facility Name
MI Vinnytsia Regional Center of AIDS Prevention and Care ( Site 5618)
City
Berezina
State/Province
Vinnytska Oblast
ZIP/Postal Code
23222
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital 5 ( Site 5616)
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Royal Free Hospital ( Site 5202)
City
London
State/Province
Camden
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Western General Hospital ( Site 5201)
City
Edinburgh
State/Province
Edinburgh, City Of
ZIP/Postal Code
EH4 2XU
Country
United Kingdom

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
Links:
URL
http://www.merckclinicaltrials.com
Description
Merck Clinical Trials Information

Learn more about this trial

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

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