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Trial record 1 of 1 for:    MK-8591A-051
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A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)

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: NCT05631093
Recruitment Status : Active, not recruiting
First Posted : November 30, 2022
Last Update Posted : November 18, 2023
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
The primary objectives of this study are to evaluate the safety and tolerability of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued baseline antiretroviral therapy (ART), through Week 48; and to evaluate the antiretroviral activity of a switch to DOR/ISL compared with continued baseline ART at Week 48. The primary hypothesis is that DOR/ISL is non-inferior to continued baseline ART, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 501 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Antiretroviral Therapy
Actual Study Start Date : February 20, 2023
Estimated Primary Completion Date : October 30, 2024
Estimated Study Completion Date : October 1, 2025

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
Active Comparator: ART + DOR/ISL
Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months on a stable oral ART are first treated with standard of care (SOC) ART for 48 weeks, followed by 48 weeks of treatment with DOR/ISL
 Drug: ART
Standard of care ART, per approved product list, taken orally

Drug: DOR/ISL
Combination of 100 mg doravirine (DOR) with 0.25 mg Islatravir (ISL) in tablet form, taken orally, once daily.
Other Name: MK-8591A
Experimental: DOR/ISL
Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months on a stable oral ART are treated with DOR/ISL for 96 weeks
 Drug: DOR/ISL
Combination of 100 mg doravirine (DOR) with 0.25 mg Islatravir (ISL) in tablet form, taken orally, once daily.
Other Name: MK-8591A


Outcome Measures
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Primary Outcome Measures :
  1. Participants with HIV-1 RNA ≥50 copies/mL at Week 48 [ Time Frame: Week 48 ]
    Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48

  2. Participants with one or more AEs at Week 48 [ Time Frame: Up to Week 48 ]
    Percentage of participants with one or more AEs from Day 1 up to Week 48

  3. Participants with an AE leading to discontinuation of study intervention at Week 48 [ Time Frame: Up to Week 48 ]
    Percentage of participants with an AE leading to discontinuation of study intervention from Day 1 up to Week 48


Secondary Outcome Measures :
  1. Participants with HIV-1 RNA <200 copies/mL at Week 48 [ Time Frame: Week 48 ]
    Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48

  2. Participants with HIV-1 RNA <50 copies/mL at Week 48 [ Time Frame: Week 48 ]
    Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48

  3. Participants with HIV-1 RNA <200 copies/mL at Week 96 [ Time Frame: Week 96 ]
    Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96

  4. Participants with HIV-1 RNA ≥50 copies/mL at Week 96 [ Time Frame: Week 96 ]
    Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96

  5. Participants with HIV-1 RNA <50 copies/mL at Week 96 [ Time Frame: Week 96 ]
    Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96

  6. Change from Day 1 in cluster of differentiation 4+ (CD4+) T-cell count at Week 48 [ Time Frame: Baseline at Day 1 and Week 48 ]
    Mean change from baseline at Day 1 in CD4+ T-cell count at Week 48

  7. Change from Week 48 in CD4+ T-cell count at Week 96 [ Time Frame: Baseline at Week 48 and Week 96 ]
    Mean change from baseline at Week 48 in CD4+ T-cell count at Week 96. This outcome measure is applicable to participants who were randomized to switch to DOR/ISL at Week 48.

  8. Change from Day 1 in CD4+ T-cell count at Week 96 [ Time Frame: Baseline at Day 1 and Week 96 ]
    Mean change from baseline at Day 1 in CD4+ T-cell count at Week 96. This outcome measure is applicable to those randomized to start DOR/ISL on Day 1.

  9. Participants with viral resistance-associated substitutions [ Time Frame: Up to Week 96 ]
    Number of participants with viral resistance-associated substitutions

  10. Low density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline and Week 48 ]
    Mean change from Baseline to Week 48 in fasting LDL-C

  11. High density lipoprotein cholesterol (HDL-C) [ Time Frame: Baseline and Week 48 ]
    Mean change from baseline to Week 48 in fasting HDL-C

  12. Participants with one or more AEs at Week 96 [ Time Frame: Up to Week 96 ]
    Percentage of participants with one or more AEs from Day 1 up to Week 96

  13. Participants with AEs leading to discontinuation of study intervention at Week 96 [ Time Frame: Up to Week 96 ]
    Percentage of participants with an AE leading to discontinuation of study intervention from Day 1 up to Week 96

  14. Participants with one or more AEs from Week 48 up to Week 96 [ Time Frame: Week 48 up to Week 96 ]
    Percentage of participants with one or more AEs from Week 48 up to Week 96

  15. Participants with AEs leading to discontinuation of study intervention from Week 48 up to Week 96 [ Time Frame: Week 48 up to Week 96 ]
    Percentage of participants with an AE leading to discontinuation of study intervention from Week 48 up to Week 96


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 HIV-1 positive with plasma HIV-1 RNA <50 copies/mL at screening
  • Has been receiving continuous, stable oral 2-drug or 3-drug combination (± PK booster) ART with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen
  • Female is not a participant of childbearing potential (POCBP); or if a POCBP uses an acceptable contraceptive method or abstains from penile-vaginal intercourse as their preferred and usual lifestyle; has a negative highly sensitive pregnancy test; and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator

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 a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening
  • Has active hepatitis B virus (HBV) infection
  • Has chronic hepatitis C virus (HCV) infection consistent with cirrhosis
  • Has a ≤5 years prior history of malignancy
  • Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A ) inducers
  • Has taken long-acting HIV therapy at any time
  • Is currently participating in or has participated in a clinical study and received (or is receiving) an investigational compound or device from 45 days prior to Day 1 through the study treatment period
  • Has a documented or known virologic resistance to DOR
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): NCT05631093


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: NCT05631093    
Other Study ID Numbers: 8591A-051
MK-8591A-051 ( Other Identifier: Merck )
jRCT2031220698 ( Registry Identifier: jRCT )
2022-502127-22 ( EudraCT Number )
First Posted: November 30, 2022    Key Record Dates
Last Update Posted: November 18, 2023
Last Verified: November 2023
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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Islatravir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Anti-Retroviral Agents