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Trial record 1 of 1 for:    8591A-054
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A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05766501
Recruitment Status : Active, not recruiting
First Posted : March 13, 2023
Last Update Posted : January 5, 2024
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: DOR/ISL Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) QD in a Phase 3 Clinical Study
Actual Study Start Date : March 17, 2023
Estimated Primary Completion Date : January 14, 2026
Estimated Study Completion Date : January 14, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV
Drug Information available for: Doravirine

Arms and Interventions
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Arm Intervention/treatment
Experimental: DOR/ISL
Participants will receive fixed dose combination (FDC) tablet of DOR/ISL (100 mg/0.25 mg) taken once daily (QD) orally from Day 1 to Week 96.
 Drug: DOR/ISL
FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily
Other Names:
  • MK-8591A
  • Doravirine/islatravir


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with One or More Adverse Event (AE) [ Time Frame: Up to 102 Weeks ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE through Week 102 will be presented.

  2. Percentage of participants who Discontinue Study Intervention Due to an AE [ Time Frame: Up to 96 Weeks ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE through Week 96 will be presented.


Secondary Outcome Measures :
  1. Percentage of Participants with HIV-1 Ribonucleic Acid (RNA) ≥50 copies/mL at Week 96 [ Time Frame: Week 96 ]
    The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 will be reported.

  2. Percentage of Participants with HIV-1 RNA <50 copies/mL at Week 96 [ Time Frame: Week 96 ]
    The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 will be reported.

  3. Percentage of Participants with HIV-1 RNA ≥200 copies/mL at Week 96 [ Time Frame: Week 96 ]
    The percentage of participants with HIV-1 RNA ≥200 copies/mL at Week 96 will be reported

  4. Percentage of Participants with Evidence of Viral Drug Resistance-Associated Substitutions [ Time Frame: Up to Week 96 ]
    Viral drug resistance is defined as participants with HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic data showing evidence of resistance to the study intervention. The percentage of participants who demonstrate drug resistance through Week 96 will be presented.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp & Dohme (MSD)-sponsored clinical studies (MK-8591A-017, -018, -020, and -033 [except for heavily treatment-experienced (HTE) participants]).

Exclusion Criteria:

  • Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-017 /-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033.
  • Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL.
  • Is a HTE participant receiving treatment in MK-8591A-019 or -033.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05766501


Locations
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Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
More Information
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Additional Information:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT05766501    
Other Study ID Numbers: 8591A-054
MK-8591A-054 ( Other Identifier: Merck )
2022-502126-40-00 ( Registry Identifier: EU CT )
jRCT2051230002 ( Registry Identifier: jRCT )
First Posted: March 13, 2023    Key Record Dates
Last Update Posted: January 5, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Disease Attributes
Pathologic Processes
Islatravir
Antiviral Agents
 Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Anti-Retroviral Agents